Software
Data or Electronic Document Management Software (EDMS)
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.
Data Management Software:
| Vendor | Claim | Website |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Gould Life Science Suite | Data Security -An optional Data Security feature provides compliance to FDA 21 CFR part11 | |
| 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 |
| 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 |
The above table lists all the Software identified by PharmOut Information Technology.
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