Software
Corrective Action / Preventative Action (CAPA) 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.
Medical Device Manufacturers 21CFR 820.100 - Corrective and preventive action
(a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for:
(1) Analysing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems;
(2) Investigating the cause of nonconformities relating to product, processes, and the quality system;
(3) Identifying the action (s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
(5) Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
(6) Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and
(7) Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
(b) All activities required under this section, and their results, shall be documented.
CAPA Systems 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
The above table lists all the Software identified by PharmOut Information Technology.
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