All computerized systems developed, delivered and/or maintained by PACIV, Inc. are validatable to meet or exceed the newly revised cGMP’s regulations of the FDA such as current Good Manufacturing Practices (cGMP’s) 21 CFR Sections 68, 210, 211.68, 501, 502, 512, 701, 704 and 820 and Part 11. All CSV deliverables will be defended from any regulatory agency (internal/external) inspection up to the retirement of the system.
To reach a validated computer system, seven (7) stages must be completed as documented evidence that provides a high degree of assurance that the system is reliable doing what it was designed to do. In any case that one of the seven stages can not be developed; proper documentation will be generated to justify its exclusion.
The seven stages that must be completed and documented during the system life cycle are the following:
- Validation Plan
- Requirements
- Design
- Source Code Review
- Testing ( test plan, IQ/OQ/PQ protocols, test summary reports)
- Supporting Standard Operating Procedures and Training Programs Security
- Contingency Plan
- Change Management
- Disaster and recovery plans
- Annual System Review
- Validation Reports ( System Acceptance)
Some of the benefits of validating a computerized system will be that REQUIREMENTS are defined, QUALITY is built into the system, START-UP is shorten, PROJECT COST is reduced and MAINTENANCE is less expensive
The implementation of this policy must be in accordance with our customers Computer System Validation Policy. In any case of differences, our client's Policies & Procedures (P&Ps) will take precedence over our P&Ps.
CSV POLICY