Software
Archiving / Mirroring Pharmaceutical Software
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.
Electronic Data Management Software:
| 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 |
| 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 |
| 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 |
| 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 |
| 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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