Software
Change Control Software for Pharmaceuticals
Please find below an impartial listing on software choices facing a Pharmaceutical Professional when choosing Change Control Software.
21 CFR 211.160 - General requirements
(a) The establishment of any specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms required by this subpart, including any change in such specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms, shall be drafted by the appropriate organizational unit and reviewed and approved by the quality control unit. The requirements in this subpart shall be followed and shall be documented at the time of performance. Any deviation from the written specifications, standards, sampling plans, test procedures, or other laboratory control mechanisms shall be recorded and justified.
The below table lists all the Change Control Software identified by PharmOut Information Technology based on our search of the internet and industry knowledge. To view possible options for other Pharmaceutical Software packages click on the relevant link below.
Change Control 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 |
| 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 |
| 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 |
| 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 |
The above table lists all the Software identified by PharmOut Information Technology.
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