Computer System Validation

Simple, compliant Computer System Validation solutions

PharmOut are specialists in Computer System Validation. We can assess your systems, or proposed systems, against GAMP software life cycle development model and part 11 / annex 11. We will then recommend any remediation required to comply with "GAMP" and the 21 CFR Part 11 or Annex 11 requirements.

A common mistake, when seeking to comply with Part 11, is to ignore the predicate rules. This incurs unnecessary expense in areas where it is simply not needed.

The FDA, after consulting the industry and the ISPE, released a risk-based guidance document several years ago. Despite the time industry has had to adopt the guidelines, it is still common practice to over-elaborate validation activities.

Design

PharmOut consultants can assist you in developing the User Requirements Specification (URS), the basis for computer system design. From the URS the design process begins. By using Quality-by-design principles, we then perform design reviews to determine the optimal design, ensuring that profitability and quality targets are met.

Criticality/risk assessment

PharmOut's validation professionals can lead the Risk/Criticality Analysis and assist with determining the impact level of computer systems. This assessment is guided by a Risk Analysis, assessing the likelihood of detection and impact of failure and documented in a matrix which indicates the level of qualification or validation recommended.

Protocols for Qualification/Testing

PharmOut an either provide templates and do the testing on a fixed price basis. Or we can provide the resources to perform the testing & documentation, under your supervision.