Software
Enterprise wide software solutions
Please find below our listing of possible software solutions for the Pharmaceutical, Medical Device or Life Sciences Industry wishing to comply with the FDA, TGA, MHRA regulations.
Enterprise Wide Software Solutions
| Vendor | Claim | Website |
| MasterControl™ | MasterControl™ integrated QUALITY and COMPLIANCE management software systems for FDA and ISO regulated industries. Integrated software systems include CAPA, Document Control, Training Management / Tracking, Change Control, Audits, Complaints Handling, eProcess Automation, Sarbanes-Oxley (SOX), etc. | www.mastercontrol.com |
| PFS Suite | PFS-Suite is intended to facilitate the engineering activities involved in automation software. | www.specsoft-pfs.com |
| ValGenesis | There are four modules in ValGenesisto manage the entire validation lifecycle from validation document number assignment to test script execution, approval, and document storage. Rreduces operations, training, and validation costs. | www.valgenesis.com |
| MasterControl™ | MasterControl™ integrated QUALITY and COMPLIANCE management software systems for FDA and ISO regulated industries. Integrated software systems include CAPA, Document Control, Training Management / Tracking, Change Control, Audits, Complaints Handling, eProcess Automation, Sarbanes-Oxley (SOX), etc. | www.mastercontrol.com |
| Datastream 7i | Datastream Systems, Inc. Asset Performance Management software, including more than Datastream’s solutions combine asset management functionality with advanced analytics for optimizing enterprise asset performance. Maintain and manage capital assets such as manufacturing equipment, vehicle fleets and buildings and create analyses and forecasts. Datastream 7iTM, Internet, web services architecture with broad enterprise asset management functionality, integrated procurement, advanced analytics and multi-site capability. | www.datastream.net |
| LiveAudit | DataMirror provides real-time data integration software that helps companies ensure cost-effective compliance with FDA Regulation 21-CFR Part 11. LiveAudit™ for DataMirror Transformation Server enables FDA-regulated companies to create real-time audit trails that preserve historical information | www.datamirror.com |
| MicroMain XM | MicroMain XM™ gives you the tools you need to streamline maintenance operations, maximize productivity and reduce costs. This asset-based computerized maintenance management system (CMMS). Automate work orders, schedule preventive maintenance tasks and completely track assets, comprehensive reports. | www.micromain.com |
| In-Sight | Cognex Corporation, the world's leading supplier of machine vision systems, announced that its In-Sight™ family of network able vision sensors are compliant with the U.S. Food and Drug Administration's 21 CFR Part 11 regulations. Cognex Corporation designs, develops, manufactures, and markets machine vision systems, or computers that can "see." | www.cognex.com |
| COMPU4 | The Compu 4 Automated Control System is specifically designed to meet the needs for all aspects of batch processing – including batch recipe creation and control, data acquisition, batch reporting, and trending. The Compu 4 is designed to meet 21 CFR Part 11 requirements. The Compu 4 is built around your choice of Supervisory Control and Data Acquisition (SCADA) packages (Intellution iFIX , Wonderware InTouch and Rockwell Software RSView32). | www.vectorcorporation.com |
| CMX, Calibration Manager | CMX is calibration management software that assists in documenting, planning, analyzing and, finally, optimizing calibration work. CMX's scalable technology and user configuration allows you to integrate it easily into other systems for a one-of-kind calibration system that fits your specific needs completely. | www.beamex.com |
| Calibration Manager | Calibration Manager® software, is among the world's leading calibration management database programs. Calibration Manager automatically calculates due dates, tracks histories and prints reports of calibration schedules. It also tracks preventive maintenance. Flexible data retrieval and reporting capabilities permit customization according to your exact needs. The electronic signature functionality was designed to meet FDA 21CFR Part 11 requirements. | www.coolblue.com |
| CATSWeb | CATSWeb is a flexible, comprehensive "all-in-one" solution designed to help firms automate a variety of business processes especially those in the quality and regulatory compliance areas. | www.assurx.com |
| Clintrial, Connect, Clintrial, Clintrace, Integrated Review, Review | Clinsoft Corporation is the world's largest provider of clinical research systems. Clinsoft's information platform enables companies to focus development resources on product "winners" sooner and has brought more pharmaceutical products to market than any other software platform. | www.clinsoft.com |
| TrialXS/EDC | TrialXS / EDC complies with FDA 21 CFR Part 11 regulation and conforms to GCP guidelines. | www.clinsource.com |
| CRF Box wireless | KEY FEATURES OF CRF BOX WIRELESS™: Patient-generated data entry via a wireless or handheld device, Edit checks to diary data before entry into trial database, 2-way communication between clinical R&D stakeholders, Diary page amendments during the trial, Multiple languages and technology platforms in the same trial Flexible generation of reminders and alerts to patients, 21 CFR Part 11 compliance. | www.crfbox.com |
| DataTrak EDC | CFR21;Part 11 Compliant. When you compare EDC product you'll find DATATRAK's Audit Trail to be the best of breed. DATATRAK EDC gives you an audit trail down to the data field. This also means that if the Investigator loses a communications connection, they do not lose data. | www.datatrak.net |
| DocuStore Repository eNOW | Biotechnology research, discoveries and applications ultimately find their way to public use. Any entity that accepts, maintains or transmits electronic data must comply with a standardized Electronic Data Interchange (EDI) format. | www.ensurelink.com |
| iSuite | etrials offers iSuite, an innovative and powerful data entry system that allows investigators and site administrators to make immediate decisions based on having cleaner data -- faster. Our eCRF form is 21 CFR Part 11 compliant. | www.etrails.com |
| Xtrials | We offer a breakthrough, workgroup management technology that is native XML-based, fully 21 CFR Part 11 compliant, and able to be customized for individual company implementations. The XTrials TM Application Architecture is a fully-scalable clinical data management environment for EDC, Clinical Data Review, CSR Analysis/Verification/Peer review, and electronic Regulatory Submissions production. | www.mymatrixml.com |
| CTMS, Impact, | IMPACT (International Management Package for Administration of Clinical Trials) is a highly flexible, web based, tried and tested CTMS. It caters for all trials, from large multi-national trials to single site, investigator-sponsored protocols. The product provides planning and tracking support for all aspects of a trial and consolidates all the information from various collection points into a single source. | www.perceptive.com |
| InForm Clinitrial Clinitrace | Phase Forward's scalable, reliable solutions suite – which integrates electronic data capture (EDC), clinical data management (CDM), and drug safety monitoring – accelerates clinical productivity and streamlines drug safety monitoring and reporting. | www.phaseforward.com |
| Esendant Clinical Network | PHT's Esendant Clinical Network fully conforms to CDISC standards and is compliant with FDA 21 CFR Part 11. | www.phtcorp.com |
| Open Text | www.opentext.com | |
| PRO_IRB | PRO_IRB™ is a Microsoft Access-based Institutional Review Board Software Application providing productivity and compliance assurance tools for managing the Institutional Review Board process. Agenda preparation, records SAE, manage continuing review. Complies and exceeds 21CFRpart11 requirements where applicable. | www.proirb.com |
| SymPro V3/V4 | The Symfo is a portable, one-hand operable, electronic patient diary capable of recording patient data in REAL TIME. This secure data transmission will provide a better follow-up of the patient without making a contact between the patient and the investigator necessary. The system has been developed and is produced according to the strict ISO 9001 procedures. The Symfo is a portable, one-hand operable, electronic patient diary capable of recording patient data in REAL TIME. This secure data transmission will provide a better follow-up of the patient without making a contact between the patient and the investigator necessary. The system has been developed and is produced according to the strict ISO 9001 procedures. The system is FDA Part 11 Compliant. | www.symfo.com |
| Silverstream V2.5 | Janssen have successfully removed the paperwork from the change control process The system is compliant with FDA regulation 21 part 11. Because the system is intranet based, changes or amendments can be made at server level and deployed immediately. | www.clients.ie/home_static.html |
| Applied Stats SPC software suite | Our Applied Stats SPC software suite meets all the requirements of 21 CFR Part 11, and provides SPC data collection, analysis and reporting solutions for pharmaceutical manufacturing processes. ASI DataMyte Quantum software, coupled with our data collection devices, provides analysis and reporting capability for process control metrics. | www.appliedstatistics.com |
| Chromeleon | New Electronic Signature and Signoff feature provides electronic signatures in conformance to FDA's 21 CFR Part 11 rules. Unique signoff levels allow users to submit, review, and approve electronic records from CHROMELEON efficiently and completely. | www.dionex.com |
| MCS Now | eMedia-IT's web-based infrastructure allows your company to meet key FDA compliancy requirements while managing the secure sharing of files within your organization as well as with other organizations, features such as: User authentication upon login, Dynamic file viewing, Group and user management, File and folder access permissions, Version control and file history, Read only audit trail. | www.stargate.ca |
| Entrust/PKI | Digital Certificate technology can be used to ensure access control, authentication and non-repudiation of digital transmissions. Entrust provides a digital certificate-based solution for digital signature and encryption, that will meet the requirements of the FDA for organizations that want to use electronic records and signatures. | www.entrust.com |
| eOriginal | The eOriginal™ system meets or exceeds all of the FDA requirements for electronic filings. | www.eoriginal.com |
| EtQ Quality Management Software | EtQ's powerful, yet flexible and configurable software platform allows you to achieve compliance in Quality Assurance, Health & Safety Management, Corrective Action Tracking, Document Control, Reporting, Quality Management and Compliance Management and many more initiatives. | www.knowledgear.com |
| GainSeeker Suite | Hertzler Systems is introducing their newest product, QA/S GainSeeker® 7 Suite. Among the dozens of new features in the new release, noted highlights include: Additional security features such as enhanced 21 CFR Part 11 compliance. | www.hertzler.com |
| DataThread, ROBAR, ROPICS, iSecurity | Innovatum products are developed using strict disciplines of validated systems in highly regulated industries. Consequently, the quality of our products exceeds accepted norms and can readily be validated within environments which currently enjoy that status. | www.innovatum.com |
| PI system | www.osisoft.com | |
| Wonderware Intouch Active X Controls | For industries that do not require validation, all this means is that Innovatum products have passed the strictest quality assurance standards. | www.qmation.com |
| RSA Keon CA RSA Keon RA | Sentry CA provides a certificate issuance and management solution that enables global Public Key Infrastructure (PKI). Xcert Sentry allows pharmaceutical companies to meet 21 CFR Part 11 regulations and take advantage of the cost savings and conveniences that e-business brings. | www.xcert.com |
| Vlog Software | Completely tamper-proof, password-protected and secure, VL-series data loggers and vLog Software produce traceable high-accuracy documentation that meets the electronic record requirements of 21 CFR Part 11. | www.veriteq.com |
| adWATCH | All of Winchester Business Systems' products and services comply with the requirements of the FDA's 21 CFR Part 11 for electronic signatures and electronic records using the ComPac software module. | www.wbsnet.com |
| Qstream iCompliance 5, Change Stream, DOCSTREAM | From the conception of a solution, to creation and delivery of content, Qstream iCompliance 4 provides the technical infrastructure necessary to build applications that must comply with 21 CFR Part 11 regulatory requirements. ChangeStream is a fully electronic Change Control Management Application to manage, track and consolidate under a single roof all activities pertaining to changes within a regulated environment. | www.migg.com |
| NetRegulus NetRM™ Enterprise Software | NetRegulus NetRM™ Software is an exciting new approach to managing Study and Quality information. It is the only product that lets you link both Study and Quality data across the entire enterprise, allowing you to span product life cycles from pre-clinical studies to post market activities. | www.netregulus.com |
| Secure Desktop 6.83 | 21 CFR Part 11 (FDA) - Secure Desktop has several features to aid the pharmaceutical, biotechnology, food, and beverage industries. Using Secure Desktop, program and data access can be controlled, user activity can be logged to disk, and users can be automatically logged off from Windows NT 4.0 or 2000 due to inactivity. | www.visualautomation.com |
| NovaGMP | Cimage NovaSoft GMP solves several major problems for pharmaceuticals manufacturing companies. The FDA requires manufacturers to adhere to Good Manufacturing Practice (GMP). With a Cimage NovaSoft solution you can easily establish, monitor and document quality, and demonstrate responsible decision making. | www.cimagenovasoftgmp.com |
| eInfo Tree, Enterprise series | Designed specifically to meet the regulatory requirements of the life science industries, the eInfotreeTM Digital Compliance solution is fully compliant with 21 CFR Part 11 requirements for Electronic Records and Signatures. eInfotree’s patent-pending Digital Compliance TM Architecture seamlessly integrates disparate "islands of information" into a regulated, controlled and compliant digital nervous system with single point access throughout the workgroup, department or enterprise. | www.part11solutions.com |
| FirstDocs | FirstDocs™ for GMP, a comprehensive prepackaged electronic document management solution in support of pharmaceutical manufacturing and quality processes. It's a part of our FirstDocs™ solution suite, which offers a set of services and software for research and development, case report form management, and regulatory submissions. | www.fcg.com |
| QSI System, | Designed specifically to meet the requirements of ISO 9001:2000, the QSi System for Quality Management helps your organization reap the benefits of ISO certification, including improved customer satisfaction and reduced costs. | www.qualitysys.com |
| LiveLink | www.opentext.com | |
| ProofMark | ProofSpace, Inc. has designed ProofMark to perfect the electronic documentation process, withstanding audit and minimizing risk. ProofMark encapsulates what occurred, when it happened and includes who participated in the activity. In the Pharmaceutical industry, ProofMark aids companies to comply with 21CFR part 11 regulations. | www.proofspace.com |
| DocCompliance | QUMAS DocCompliance® is a complete enterprise compliance application designed exclusively to manage the full lifecycle of regulatory controlled documentation. Organizations are assured of compliance with regulatory bodies' guidelines and directives. The risk of non-conformance is avoided through complete auditing and traceability on document history including event logs, audit trails and comprehensive reports. | www.qumas.com |
| ApproveIT | Meets FDA 21 CFR Part 11 right out of the box. ApproveIt from Silanis moves signature approvals on-line. Its native support for the most widely used document creation tools leverages your organization's existing communications infrastructure so you can continue doing business as usual, with little or no additional training. | www.silanis.com |
| InfoThehna, | Infotehna products and solutions for managing documents and records in the highly regulated pharmaceutical industry. my-Pharma™ consists of the pre-packaged solutions detailed below which cover the requirements of different business areas such as Regulatory Affairs, QA, etc. my-Pharma™ is based on my-Process™ a collaborative web environment developed on Documentum and is in line with 21 CFR 11 regulations. | www.infotehna.com |
| TrackWise | Sparta Systems' TrackWise is a powerful system for tracking and managing: Problem Reports, Bugs/Defects, Change Requests, Customer Complaints, Corrective Action Items, Investigation Reports, Audit Observations/Findings. | www.sparta-systems.com |
| Mobil Data Acquisition | The Sycamore Group is helping companies comply with 21 CFR Part 11 through Mobil Data Acquisition. Mobile wireless devices provide laboratory technicians immediate and real-time access to environmental data systems while meeting regulatory compliance standards. The real-time communication eliminates redundant data entry time, reduces the need for redundant testing and ensures data integrity. | www.thesycamoregroup.com |
| Empower | Millennium 32 Chromatography data system. Adds complete 21 CFR Part 11 compliance, dual-tower control, and data acquisition support for Agilent 5890 and 6890 gas chromatographs and the Waters Alliance dissolution system, pattern recognition algorithms for chromatogram comparisons, and full support of Microsoft Windows web standards. | www.waters.com |
| Chemera | Chemera, inc. has developed proprietary software utilizing 128-bit encryption technology that fully complies with 21 CFR part 11 (FDA regulation). | www.chemera.com |
| Maximo | With MRO Software's vision and usable solutions, you can optimize performance. We have helped thousands of asset-intensive organizations; including all 13 of the largest pharmaceutical companies in the world. | www.mro.com |
| PAS-X-MES | Werum supplies perfect technical MES (Manufacturing Execution Systems) solutions and services for the GxP/FDA related pharmaceutical industry in compliance with 21 CFR 11. The standard PAS-X MES product range provides easy qualification and validation. PAS-X supports a rich set of features that help to streamline the whole pharmaceutical production process e.g. Electronic Batch Recording/EBR | www.werum.com |
| A-S Login | A-S login provides complete 21 CFR Part 11 compliant user login functions, and a comprehensive administrator console. The software uses complex encryption and checksumming techniques to protect data from accidental or deliberate falsification. | www.aitken-sci.co.uk |
| EBR | Siemens has continued to lead the competition in 21 CFR Part 11 with numerous installations in the pharmaceutical industries. Those installations include the creation of one of the first paperless pharmaceutical manufacturing facilities specifically designed to meet the requirements of 21 CFR Part 11. | www.sea.siemens.com |
| SmarTeam for FDA kit | SmarTeam for the FDA solution provides your company instant compliance with the technical requirements of FDA Regulation Rule 21 CFR Part 11 and facilitating compliance with the procedural control requirements. | www.smarteam.com |
| CompasSoft Enterprise | Compassoft’s powerful automated tools for managing the unrecognized risks your company faces every day. Compassoft's software discovers, validates and controls masses of information, keeping you in compliance with regulatory mandates such as Sarbanes-Oxley and the FDA's 21 CFR Part 11, and reducing the risks of accounting errors and fraud. | www.wimmersystems.com |
| eGMP | A complete, integrated software solution that enables companies to create custom enterprise software. The eGMP software suite comes preconfigured with custom data table templates, enables companies to manage ALL aspects of workflow, from SOP, Specifications, Methods, Validation Reports, Qualification Protocols, and Design Reviews to time card management, procurement, inventory and more. eGMP has a complete security model built in. eGMP is compliant with FDA regulations, including 21 CFR Part 11. | www.egmp.com |
| POMS | Honeywell-POMS Corporation is the global leader in providing Manufacturing Execution Systems (MES) for the healthcare products and consumer packaged goods industries. Honeywell-POMS provides integrated solutions that help you control, track, and view every aspect of your product development life cycle. POMS products deliver value and help you | www.poms.com |
| JD Edwards OneWorld | Designed to meet the needs of regulated companies, J.D. Edwards OneWorld solutions not only ensure the integrity of authorized signatures executed within the OneWorld environment, they also enable companies to feel secure that the transactions being executed are meeting the approval, audit trail, and time stamping functions required in 21 CFR Part 11. | www.jdedwards.com |
| Matrix 10 PLM environment | The Matrix PLM Platform serves as the foundation for the overall Matrix 10 environment and combines an open, flexible Internet platform with extensive collaboration services, an array of adaptable development tools. The growing collection of software offerings provides proven product lifecycle capabilities - from concept and design through manufacture and ongoing service. | www.matrixone.com |
| PMX,MES, CTM, RDM, MQS | Propack Data a pioneer and visionary in the Manufacturing Execution System (MES) sector, Focusing on FDA/GxP-regulated industries such as pharmaceuticals, food-stuffs and cosmetics, Propack Data provides validatable standard software for the entire manufacturing and packaging processes in the field of supply chain execution under an ERP system. Propack Data's current release, PMX 3.1, satisfies the requirements of 21 CFR 11. | www.propack-data.com |
| MFG/Pro | QAD understands patient device tracking (PDT), serial traceability, and validation, and what these conditions mean up and down the business chain, from procurement to distribution and all points between. | www.qad.com |
| Revelink's Enterprise Executive | Revelink has developed a validated enterprise application development platform that enables developers serving regulated industries to build enterprise applications in 10% of the time currently required. Building with Revelink’s Enterprise Executive results in Enterprise Applications that are robust & scalable; are based on open software standards; use common enterprise repositories; and are 21CFR11 compliant. | www.revelink.com |
| mySAP ERP | Create of EBR after final completion of Production order, using documentation of process as well as of results of the process, including staged and identified Materials and reconciled material consumptions, EBR approval can be made mandatory for usage decision. Full support for 21 CFR Part 11 signature and record requirements. | www.sap.com |
| Sign IT | Communication Intelligence Corporation (CIC), provides input, security and electronic signature offerings to Enterprises, OEMs, integrators, Asps, Strategic Partners and End Users. And by making possible the legally secure electronic signing of documents anywhere at any time, CIC leadership is a prime mover of businesses toward a paperless world. | www.penop.com |
| DaonSign | Biometrically secured electronic signing capabilities for the Pharmaceutical Industry. Daon's e-signature solution adheres to Worldwide Regulations & Legislation around the use of electronic signatures. | www.daon.com |
| Gould-PoNeMah P3-Plus | The P3-Plus Data Security Option utilizes a ‘Smart Card’ for each user. These smart cards are initialized with unique encryption Public/Private Key set for digital signatures. Files can be electronically signed using the operator’s electronic signature. | www.lintonist.co.uk |
| CyberLAB | CyberLAB™, is designed to help you achieve 21 CFR Part 11 compliance, with features like CyberLAB's Electronic Signature plug-in. Utilizing Adobe Acrobat, an industry-standard technology, CyberLAB lets you electronically sign documents, placing an encrypted signature within the document and an unalterable "watermark" on the page indicating the signatures validity. | www.micromass.com.uk |
| Q&MIS | Pilgrim's Electronic Signature component provides the necessary controls for each electronic signature to be unique to each individual. | www.pilgrimsoftware.com |
| Tamarin Integrity Server | The Zolera Tamarin Integrity Server protects critical information assets and essential online business processes with digital signatures and encryption. It is designed to conform to regulations and best practices associated with information integrity, such as the 21CFR11 FDA regulations | www.zolera.com |
| CoreDossierX | CoreDossierX Features can be used alone or in conjunction with your document management system Audit trail capabilities support 21 CFR Part II compliance on a per publication basis, Enables the assembly of smaller publications that feed into larger submissions. Automatic finishing options: table of contents generation, cross-references, headers, footers, watermarks and pagination schemes. | www.liquent.com |
| Self-sign | The digital signature solution that is provided with the full acrobat package is called “self-sign”. This solution is 21 CFR Part 11 compliant and will provide an immediate solution to using electronic signatures with minimum investment and minimal impact on legacy systems. | www.malvern.co.uk |
| TrendReader Standard Data Logger | ACR Systems TrendReader Standard Data Logger Software, includes data validation that permits our software and hardware to conform to the FDA’s 21 CFR Part 11 regulations. Data viewed on either the PC or printed form is authentic by providing a data file sign-off mechanism, a CRC check (Cyclic Redundancy Check) for data integrity, and an overall data validation pass/fail statement with sign-off right on the graph. | www.acrsystems.com |
| EMSS | Compliance Software Solutions Corporation (CSSC) has developed the Environmental Monitoring Software System (EMSS©) to comply with the requirements defined in the FDA’s 21 CFR Part 11 for Electronic Documents | www.csoftsol.com |
| Validator 2000 LabWatch | The Validator 2000 meets all the new FDA regulations for thermal validation, including 21 CFR Part 11 on electronic signatures and records. It provides many time-saving benefits such as automating sensor calibration and report generation. The LabWatch System operates in compliance with the FDA regulation on 21 CFR Part 11 Electronic Signatures and Records | www.kayeinc.com |
| Inspection Manager | TISCOR designs software for hand-held computers for technicians performing site and equipment inspections. TISCOR solutions prove compliance and prevent the falsifying of records. Among TISCOR's many products is Inspection Manager, which effectively addresses 21CFR Part 11 | www.TISCOR.com |
| UNICORN Control System,V4.1 | Unicorn Control System version 4.1 was audited in May 2001 and was found to fully conform to all current and relevant US FDA guidelines and regulations including 21CFR part 11. | www.amershambiosciences.com |
| Connect Turbochron | Use CONNECT to transfer data between SQL*LIMS and Turbochrom. With Turbochrom Client/Server, the embedded GLP/GMP features provide the most secure and documented data handling system ever. Turbochrom Client/Server provides controls for user and instrument access, user configuration of software menus and screens, file access, controlled modification of active methods and sequences and more. | www.insturments.perkinelmer.com |
| Class VP | Supplier of Chromatography and analytical equipment, data files can be archived by VP Archive software if acquired on either Lab Solutions (GC) software or Class VP (HPLC) software interfaced with Shimadzu equipment | www.shimadzu.com |
| TeC | TeC, Taratec’s e-Compliance Solution, will help ensure compliance for computer systems used in all phases of the product development cycle. | www.taratec.com |
| TPW II | Engineered specifically for time-squeezed labs in a regulated environment, the TPW completely automates content uniformity and composite assay testing, from preparation through sample introduction and provides an audit trail consistent with 21 CFR Part 11. | www.zymark.com |
| EZ Chrom Elite | EZChrom Elite v2.7 chromatography data system fully complies with 21 CFR Part 11 Electronic Signature requirements. the signature information (Who, When, and Why) is stored within the data file with a CRC checksum to prevent tampering with the signature record. This information is also logged in the data file audit trail. | www.scisw.com |
| WinNonlin WinNonMix | Pharsight is also working with our customers to help them achieve compliance with 21 CFR Part 11 regulations. The Enterprise Editions of WinNonlin and WinNonMix are steps toward achieving this compliance which can be implemented today. | www.pharsight.com |
| Pinnacle | Pinnacle is the first CDS to be designed from the ground up to meet Part 11 requirements. Not only do Pinnacle's electronic records meet Part 11 requirements, system administrators can also minimize the compliance burden by determining when electronic signatures and modification reasons are required. | www.beckmancoulter.com |
| Q_DIS/R | The extended use of computer technology and the increasing automation in the field of modern chemical analytic, produces large quantities of analytical data. In consideration of: the diversity of data sources, GLP and GMP guidelines, governmental requirements (FDA 21, CFR Part 11), company objectives | www.creon.com |
| Datastream | Numoda DataStream wireless solution enables the collection and redistribution of error free study data in significantly less time than existing methods. Eliminates time of testing and data entry Greatly reduces paperwork and overall costs Creates a virtually Error-Free Study environment, Works with any handheld device Secure and validated 21 CFR Part 11 compliant | www.numoda.com |
| EndoScan-V | Our EndoScan-V version 1.0.13 is the first endotoxin-specific software that addresses the 21 CFR Part 11 requirement for validation. | www.criver.com |
| OMNIC | Document explains at www.nicolet.com/labsys/pdf/21cfr.pdf how OMNIC is part 11 compliant | www.thermonicolet.com |
| MicroLog & OmniLog systems | The MicroLog and OmniLog systems are designed to exist within a 21CFR Part 11 environment and provide the basic functionality to support our customer's compliance efforts. Biolog provides all of the necessary software features, validation packages, and optional assistance to support full (including 21 CFR Part 11) compliance. | www.biolog.com |
| Chemstation Plus | The system enables users to comply with audit and approval requirements such as 21 CFR Part 11. | www.chem.agilent.com |
| Analyst SQL LIMS | Analyst™ software. Automated software routines rapidly and completely optimize the instrument for quantitative analysis. Queries, metric plots, configurable results table, and slide show. Analyst software provides flexible data acquisition, fast and easy data. SQL*LIMS® software is a complete LIMS that gives you control over sample tracking, laboratory processes and workflow, data access and storage, and regulatory compliance. Supports your laboratory’s compliance with the FDA’s 21 CFR 11 Rule. | www.appliedbiosystems.com |
| LABTrack | LABTrack incorporates (21 CFR Part 11). Electronic Signature is a mechanism to accurately identify the user of the software at the time data is saved. It can do so using either controlled passwords or biometric devices like fingerprint readers. LABTrack supports both. | www.labtrack.com |
| BlazeLIMS Enterprise Plus | BlazeLIMS Enterprise Plus provides flexible sample registration functions, including ad hoc logs, batch/requests, QC batch, and stability studies, with manual or automated results entry in a 21 CFR Part 11-compliant environment. | www.blazesystems.com |
| StatLIA | Brendan develops laboratory software for all immunoassay testing technologies. For automating workflow, the software is designed for easy interfacing and networking to any LIM system, instrument and PC. And all raw, computed and statistically analyzed data are organized, secured, and easily accessible. 21 CFR Part 11 Compliant. | www.brendan.com |
| SLIM | 21 CFR Part 11 Compliant; “All changes are event logged. Audit trail includes references to the date and time of the change, the user making the change, the event type that caused the event to be logged, and description. When data results are changed a change code and comments are logged. Multiple levels of security. “ | www.hascientific.com |
| Cerity | Agilent Cerity Networked Data System for Pharmaceutical QA/QC data system is part of the Agilent Cerity networked data system family of chromatography software. (Formerly Chemstation.) | www.agilent.com |
| 2.0 Dissolution data Management Software | The new Version 2.0 Dissolution Data Management software from Icalis Data Systems employ an extensive range of restrictive access rights to aid compliance to 21 CFR Part 11 and Online Sample processing with Auto samplers including sample dilution. An audit trail is kept of all activity in the system which is also user query able to help keep information in an orderly manner. | www.labocat.nl |
| Watson LIMS | Watson ™ has been expressly built to promote compliance with GLP regulations and the 21 CFR Part 11 guidance. Watson™ is capable of handling standard and complex study protocols, providing audit trails to track deviations and amendments to each study. Watson™ has full bi-directional interface capability to analytical instruments, tracks shipments and samples through user-designed barcode labels, supports a wide range of PK/TK analyses, and organizes study results in a unique document management system. | www.innaphase.com |
| Debra Laura | Debra, by Lablogic Systems, Ltd., is a Protocol-Driven GLP-Compliant Laboratory Information System (LIMS) designed to meet the unique needs of an ADME Laboratory environment. Laura 3 is the latest evolution. Laura 3 offers the researcher the facility to create and edit methods, set up sample runs and view data collection in real time across the network without being confined to the bench-top PC. | www.lablogic.com |
| LimsLink | LimsLink is the complete instrument to LIMS interfacing solution, designed to collect data from a broad range of instruments, reformat that data and report it to any LIMS or database application. With 100 levels of password protection and a full audit trail implementation, LimsLink provides the level of security and accountability required to make it 21 CFR Part 11 compliance. | www.labtronics.com |
| LabWare LIMS | LabWare's successful validation record and compliance to 21 CRF Part 11 guidelines are some of the reasons why many of the world's pharmaceutical companies have standardized on LabWare LIMS. | www.labware.com |
| Sherlock 4.0 | The MIDI Sherlock Microbial Identification System (MIS) is 21 CFR Part 11 compliant. Data is stored in a single, secure file that cannot be altered by ordinary means. Maintains data integrity such that data can be utilized to regenerate the original results. Provides designated personnel with capability to review, approve and electronically sign records. Creates an audit trail of all entries and actions that create, modify or delete an electronic record. | www.midi-inc.com |
| RESULT | RESULT™ Software Provides tools to comply with 21 CFR Part 11 Regulations The operation of Nicolet Industrial Solutions’ analyzers is simplified with its software. RESULT was designed for the specific requirements of process instrumentation. With digital signatures, an audit trail and Logon/Passwords, RESULT helps you meet the requirement of 21 CFR. | www.nicoletindustrial.com |
| ARCHIVE UNIFY VISION | NuGenesis provides an application-independent method for storing and cataloging raw laboratory instrument data as well as human readable information from common business applications. You can provide auditors with documented evidence back to the original source. NuGenesis Technologies products work as an application independent Scientific Data Management System (SDMS) which automatically aggregates data from disparate sources providing greater access and insight into critical knowledge generated in the laboratory. 21 CFR Part 11 compliance. | www.nugensis.com |
| WintSOTAX | WinSOTAX is a modular and configurable software package to collect data from various laboratory instruments, to store this data in a database, to retrieve it for analysis, monitoring and report generation. From the beginning the package has been developed following the rules of GLP, GALP and the GAMP guidelines. It therefore matches the requirements of 21 CFR Part 11 with few exceptions by design. | www.sofax.com |
| Nautilus Atlas | Nautilus sets the standard in delivering LIMS functionality into the laboratory. Nautilus includes assisting customers in complying with 21 CFR part 11. Nautilus can also play a compliance role in organizations certified to ISO9001 standards. Thermo LabSystems has been developing and supporting Chromatography Data Systems (CDS). Atlas™ is our latest generation validated CDS solution. | www.labsystems.com |
| GRAMS/A1 V7 | Thermo Galactic's latest version of its popular spectroscopy data processing software, GRAMS/AI provides tools to help laboratories handle data in a way that is compliant with 21CFR part 11 | www.galactic.com |
| ePMC | VelQuest's ePMC solution acquires data electronically at its source, links the data to analytical test procedures, secures the data and provides a platform for a wide range of IT applications. Furthermore, the VelQuest ePMC solution provides a means to meet 21 CFR Part 11, governing the use of electronic records and signatures in regulated laboratories. | www.velquest.com |
| NoteBookMaker | NoteBookMaker™ is a totally secure, completely electronic Laboratory Notebook. The first electronic notebook that looks and prints like a real notebook. This system is easily modified and can be custom designed to fit any organization. NotebookMaker meets the requirements of 21CFR part 11 | www.NoteBookMaker.com |
| LIMS | DUII develops and markets its products and services of LIMS, 21CFR11-aware computational infrastructure, and Standard Operating Procedure (SOP)-driven networks. These satisfy the requirements of 21CRF11 by authority check, operational system check, device check, SOP, electronic signature and closed systems. DUII creates tools to enhance communication and to enforce compliance. | www.duii.com |
| Mainsaver EAM | Cayenta's Computerized Maintenance Management Software is used by companies to minimize operation costs and maximize productivity. Mainsaver is a total solution for Enterprise Asset Management (EAM). Mainsaver offers a robust Enterprise Asset Management (EAM) solution, professional consulting services, implementation and training services and now compliance to FDA’s 21 CFR 11. | www.cayenta.com |
| Entegreat | EnteGreat has helped our Life Sciences clients plan, select, design, and implement maintenance management systems in both large and small plants. We have helped customers roll out this type of solution on an enterprise basis, while reducing the overall systems implementation and long term ownership costs and speeding up your time to value and reducing your program risks | www.entegreat.com |
| Avantis® | Avantis enterprise asset management system Foxboro I/A, Performance Measurement and Management Consultancy, Home Contact, Upstream Personal Healthcare Pharmaceutical Power Pulp and energy chemicals and maintenance. Updating asset maintenance procedures. Performance Measurement and Management group can help | www.invensys.com |
| MAPICS | With MAPICS, you can schedule and record maintenance functions; manage materials, components and products at multiple locations; and monitor operations at the plant, line or machine level. MAPICS Maintenance & Calibration Management provides you with the tools you need to properly manage your maintenance management program. | www.mapics.com |
| RSMACC | With a Rockwell Software Maintenance Solution you will no longer need multiple databases and spreadsheets to keep track of your people, the jobs they are doing and the tools they need to do their jobs. These activities are centralised, making maintenance more predictable and preventable. Software modules include Maximo Asset Management Software, RSMACC Maintenance Automation Control Centre. | www.rockwellautomation.com.au |
| IntoPlus.21 & Batch 21, eBRS | Aspen Technology Inc. announced new software solutions that provide pharmaceutical and other regulated process manufacturers with a broad range of solutions to comply with Title 21 of the Code of Federal Regulations. | www.aspentech.com |
| ProcessPro | Decision Management International, Inc. develops leading-edge software for FDA regulated industries. The integrated solution set includes a robust document-authoring and control suite, resource-tracking suite, and an RF-enabled Weigh Dispense application. Products are engineered specifically for 21 CFR Part 11 compliant environments, and support electronic signatures, real-time data exchange with legacy systems, and handheld barcode scanning technology | www.processpromfg.com |
| CIS Chemical Inventory Sys | ChemSW announced a new option for its CIS Chemical Inventory System® that provides audit trail and electronic signature, for 21 CFR Part 11 compliance. The system incorporates multiple levels of security, transaction logging and signature verification. Ideal for use in pharmaceutical laboratory applications, the new security and audit trail option allows the system administrator to determine which users are authorized to make various kinds of changes, and enables accurate tracking of all change sources. | www.chemsw.com |
| Vision Software | Foss NIRSystems, Inc., a unit of Foss A/S of Denmark, is the world's leading supplier of scanning Near Infrared products and services for the pharmaceutical and chemical markets. Our extensive application knowledge, global distribution, and support network ensures efficient method development and routine implementation for years to come. Our software is fully compliant to 21 CFR, Part 11 for the benefit of our pharmaceutical customers | www.foss-nirsystems.com |
| Advant | Layered on to and designed to be integrated into the hardware packages is the expertise of ABB’s Knowledge solutions. Continually evolving to meet the current and emerging standards important to the Pharmaceutical business, such as Electronic Batch Records based on 21 CFR part 11, or Batch Control Systems compatible with ISA S88.01 standards, ABB prides itself in providing the customer the optimized package solution for his current and future needs | www.abb.com |
| Rapid Pharm | Automsoft's RAPID-Pharma is the first Plant Information Management System to offer out of the box compliance with the specification, which will enable companies to keep complete audit trails of their electronic records in a highly secure system. | www.automsoft.com |
| CIMScan | The FDA has now started aggressive enforcement of 21 CFR Part 11, which the regulation regarding electronic records and electronic signatures. CIMScan now contains all the necessary functions and capabilities to insure compliance. | www.cimtechniques.com |
| CIWOS | CSEngineering AG has software called CIWOS that is 21 CFR Part 11 compliant. | www.ciwos.com |
| DeltaV | The DeltaV™ digital automation system delivers integrated batch automation that’s easy to engineer, easy to use, and easy to validate. It’s built to S88 standards and fully addresses the FDA’s 21 CFR Part 11 requirements with integrated recipe and campaign management, batch history, automatic version and change management | www.easydeltav.com |
| Acceliant | Enmed's Acceliant™ Clinical Trial Solution is a comprehensive, flexible, and integrated solution designed to improve the speed and efficiency of clinical development. The Acceliant Clinical Trial Solution has been designed to exceed current industry regulations for clinical trial software, including the FDA 21 CFR part 11 | www.enmed.com |
| DeltaV | Significant batch enhancements in the Version 5 release include support for both running batches in campaigns and enhancements focused to support FDA regulations in 21 CFR Part 11. New patented Configuration Audit Trail software controls, manages and tracks all changes to the DeltaV configuration database saving time, effort and improving accuracy of configuration management. This software supports electronic record keeping per 21 CFR Part 11. | www.frco.com |
| Genesis32 | ICONICS, a leader in the development of Web-enabled OPC-based industrial automation software for Microsoft® Windows® operating systems, announced that Version 6.1 of GENESIS32™ offers a wide variety of tools for complying with the FDA 21 CFR 11 regulations. It enables proper handling and recording of FDA-regulated electronic information, and applies "electronic signatures" such that the FDA considers them to be "equivalent" to that of handwritten signatures and documents. | www.iconics.com |
| iFix iBatch | Intellution, Inc., developer of industrial automation software, has been delivering the industry's most advanced HMI/SCADA, batch, softlogic, and internet solutions. Working in unison with key biotech and pharmaceutical representatives, FDA regulatory personnel, original equipment manufacturers and systems integrators, Intellution is developing the tools that will empower all FDA-regulated companies to come into compliance. | www.intellution.com |
| Foxboro I/A Systems Wonderware Avantis Eurotherm | Invensys Pharmaceutical Solutions, a division of Invensys Production Management is a leading supplier of manufacturing control (Foxboro I/A Series System, Wonderware), manufacturing execution (Avantis) and environmental systems (Eurotherm) that meet and exceed the guidelines of 21 CFR part 11. Invensys Pharmaceutical Solutions has a dedicated group of pharmaceutical engineers and specialists focused on this industry, regulations, and new technology tools. Our unique solution includes a full range of products, automated tools, validation services (VTI), and procedures to help comply to 21 CFR part 11. We leverage our expertise to provide systems, tools, policies, and procedures for compliance. | www.foxboro.com |
| O.N.G. Automation are the official Rockwell Automation (Allen Bradley) and Foxboro I/A DCS Authorised integrator in Ireland, providing us direct access to the vast range of services and support which is available from both Companies. O.N.G. Automation has proven experience in the implementation of Control Systems from design stage through to final commissioning, In the Pharmaceutical, Biochemical, Food, Water and Electricity generation industries. We specialise in GAMP3 and 21 CFR part 11 compliant systems. | www.ongautomation.com | |
| APSS-200 Automated Parenteral Sampling System | 21 CFR Part 11 Compliant; Secure System Audit Trails; Encrypted Data; Ease of Validation; Unique User Names And Passwords; Software Validation Notebook | www.prmeasuring.com |
| MAP 80 Prisymedica | Prisymedica is the only label design and production software that exceeds FDA standards for compliance, as demanded by the Pharmaceutical, Clinical Trials and medical device industries. Prisymedica, the latest product from MAP80, has been specifically introduced to meet the requirements of the FDA 21 CFR Part 11 rules regarding Electronic Records and Electronic Signatures. | www.map80.co.uk |
| Many Products | Process Analysis & Automation Ltd provides state-of-the-art automation and measurement technology to the pharmaceutical and chemical industries. Custom software and application services. Many products listed as 21 CFR part 11 compliant | www.paa.co.uk |
| RSView32 | Rockwell Automation has announced that its flagship HMI products, RSView32™ and RSView32 Active Display System™, fully support the development of projects and systems that comply with FDA (Food and Drug Administration) Title 21 - Code of Federal Regulations - Part 11 (21 CFR Part | www.suppor.sofware.rockwell.com |
| InBatch | InBatch has been designed to meet the requirements of even the most regulated industries. InBatch is100% compliant with the United States Food and Drug Administration (FDA) final ruling on Electronic Records and Electronic Signatures referred to as 21CFR Part 11. | www.wonderware.com |
| ICPExpert | Varian, Inc. understands the importance of providing software tools for its customers that facilitate their compliance with US FDA regulations. Varian’s instrument control software provides its customers with a robust, reliable platform that continues to evolve to meet their changing requirements. In continuing with this commitment, it is Varian’s intention to provide software for selected Optical Spectroscopy Instruments to help its customers meet the requirements of the FDA Electronic Records and Electronic Signatures Rule | www.varianinc.com |
| Agile Anywhere | Agile Software Corporation provides collaborative manufacturing commerce solutions for the e-supply chain. The Agile Anywhere™ product suite allows supply chain partners to leverage the Internet and form virtual manufacturing networks for design control, product introduction, manufacture, and change. Agile Buyer™ enables Internet-based demand aggregation, RFQ processes, and online procurement of direct (production) materials. Agile Anywhere is 21 CFR Part 11 compliant for electronic records and electronic signatures with a proven validation methodology. | www.agilesoft.com |
| Compliance Builder | We have developed Compliance Builder: The Turnkey Part 11 Compliance Solution, which has been designed for FDA services. Regulated environments to bring their existing or legacy data collection systems into 21 CFR § 11 compliance. This turnkey solution integrates seamlessly and quickly into existing topology and is delivered with all required software, | www.stelex.com |
| Projeca | Provides compliance with government and regulatory regulations such as FDA 21 CFR Part 11 | www.tenrox.com |
| Gould Life Science Suite | Data Security -An optional Data Security feature provides compliance to FDA 21 CFR part11 | |
| Argus Safety Easy Trak | Argus Safety ™ Features: 21 CFR Part 11 Compliant ICH E2B - Electronic Submission ICH E2C - PSUR Compliant with current MedDRA™ versions CIOMS V EasyTrak ™ Features: 21 CFR Part 11 Compliant Meets FDA complaint handling requirements Integrated adverse-event reporting for FDA and EU Device Vigilance Reporting Return Goods Authorization Alternate Summary Report | www.relsys-inc.com |
| Sample Guardian | Software Associates International,® LLC (SAI), is a leading provider of innovative and practical information-processing solutions that meet the specific sales and marketing needs of the Life Sciences industry. SAI has demonstrated the existence of adequate procedures and controls within Sample Guardian™, which are designed to ensure the authenticity and integrity of electronic records utilized to meet requirements of the PDMA. In addition, SAI implements extensive documentation outlining their processes and procedures. It is PDMA, Inc.'s regulatory opinion that Sample Guardian complies with the requirements 21 CFR Part 11 pertaining to closed systems. | www.dendrite.com |
| cCure 800 security management platform | Software House Enterprise Solutions has years of experience building software solutions for the pharmaceutical industry. Some of our systems have been validated, and all of our work is done according to the high standards maintained in this demanding, regulated environment. Based on our own internal SOP's, our systems are built to comply with 21CFR11 (when required), with full implementation of electronic signatures. | www.swhouse.com |
| TrustedTime | Trusted Time is a solution for providing the necessary components to meet the e-business need for secure and non-repudiatable time stamps. It is comprised of two main concepts: the security of the time stamp and the auditability of the time stamp. The security aspect addresses both the transmission of the time from a National Measurement Institute to the local time stamp system and the protection of time and audit information within any of the systems that the time stamp may reside in along the way. The audit nature of Trusted Time is the storing of time source and cryptographic information within each time component and the PKIX-compliant time stamp itself. | www.datum.com |
| DataPro/DataGuard | Ionics Instrument Business Group (formerly Sievers Instruments) makes the world's most sensitive and selective scientific instruments to measure total organic carbon (TOC) for the pharmaceutical, semiconductor and power industries. A 21 CFR 11 compliant Sievers brand TOC system is available with a new DataPro/DataGuard software package that includes audit trails, electronic signatures and user-level security. | www.ionicsinstruments.com |
| TOCTalk V3.5 For Phoenix 8000 | TOCTalk Version 3.5 combined with the reliable, high-throughput Phoenix 8000 TOC Analyzer is the ideal solution for today's Pharmaceutical water for injection (WFI) and clean in place (CIP) applications. | www.tekmar.com |
| Training Tracker III | The Food and Drug Administration (FDA) mandates strict regulations regarding electronic signatures and audit trailing on electronic data collection methods under 21 CFR Part 11. Healthcare manufacturers using electronic record-keeping systems must comply with stringent regulations regarding the training of their employees, including the methods of recording and reporting such training for audits. Training Tracker III helps companies stay in compliance with these regulations by tracking employee training records and cross-referencing employees with their job titles / grades, courses required for those jobs, instructors and course scheduling. Once an employee's training has been completed, the information is recorded with the electronic signature, and all changes to that record are also date- and time-stamped for auditing purposes. | www.ihshealthgroup.com |
| ISOTrain | ISOtrain is a compliance driven training management software that meets government regulations, ISO 9000 standards and comprehensive validation protocols for a total quality based training. It has been developed based on industry reactions to government inspection observations (FDA, OSHA, EPA, etc.), 483's citations, and current or future client's requirements. Yes, ISOtrain is 21 CFR Part 11 compliant! | www.isotrain.com |
| Isotrain Training Management Solution | ISOtrain Training Management Solution is a powerful compliance driven, quality based training tracking system. ISOtrain allows you to manage employee training records on your global network. With a click of a button, you can notify employees of scheduled training, e-mail a report to management, review employee qualifications, or retrieve a course outline. ISOtrain runs on multiple desktop platforms, network operating systems and databases. Validation is made easy with a comprehensive validation package. | www.isotrain.com |
| TVM(The Validation Manager) | We are on the verge of launching version 2.0 of TVM that is our own Windows-based software package offering an expert knowledgebase of compliance and regulatory information to assist with every kind of validation project. Using The Validation Manager can greatly reduce the cost and complexity of managing validation projects thanks to the unique use of a Tractability Matrix and OneClick preparation of validation TVM also designed to be fully compliant with 21CFR part 11 | www.gmps.com |
| INDexxis | INDexxis™ is designed to manage data in accordance with predicate rules (GxP) and the new regulations on electronic records and electronic signatures, especially FDA 21CFRpart11. | www.biomedian.com |
| SmartSolve | Pilgrim’s solutions help you effectively manage corrective and preventive actions (CAPA), investigations, customer complaints, internal and external assessments, document control, supplier quality, equipment calibration and maintenance, and employee training to help you produce the best products at the lowest cost. | www.pilgrimsoftware.com |
| DocsMinder | Docsminder is powerful yet simple to use Windows based software specifically designed for the effective and efficient management of hard copy documentation throughout its entire life cycle, from the moment of creation through to ultimate disposal. | www.docsminder.com.au |
| Info-Organiser | Info-Organiser is a windows based electronic filing system than allows you to store all your business files, both paper and electronic, in a central location, that is indexed for easy retrieval. | www.info-organiser.com.au |
| DocuXplorer | DocuXplorer offers affordable document management systems that give any size business the ability to quickly find, share and access all document types, both scanned in paper and electronic computer-generated files, from one easy-to-use desktop screen.DocuXplorer Enterprise provides users with a full set of features including; Document Capture, Library Functions, Versions, Audit Trail, Annotation, Viewing, Security, Communication, PDF Print Capture, Integration with Microsoft Office, and extended database, display and reporting features not found in other document management applications. | www.docuxplorer.com |
| Aspentech | Aspen Technology, Inc, is the leading supplier of integrated software and solutions that enable process manufacturers to automate and optimise their plants and extended supply chains while enabling e-Business. AspenTech offers the industry's broadest family of scaleable solutions allowing our customers to be successful in the Internet economy. | www.plantsolutions.com.au |
| ensur | Web-based quality management systems for FDA and ISO regulated companies. One platform provides document control, change control, complaint handling, investigations, CAPAs, employee training/certification tracking, product specification management, version control, and compliance testing. | www.mysticmsi.com |
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