21 CFR Part 11 still remains in effect after the withdrawal of the respective guidances by the FDA. The implementation of Part 11 will even be enforced more strictly in the future for all the areas which really are relevant to the quality of drug products. Solvias assists you in all the tasks necessary to pass FDA inspections when it comes to computer systems:

• Planning and Performing Computerized Systems Validation
• Implementing 21 CFR Part 11 (Electronic Records & Electronic Signatures)
• Performing Supplier Audits

The Solvias CSV consulting team consists of individuals with substantial experience in both regulatory compliance and information technology. Our approach to Computerized Systems Validation relies on a profound knowledge of Good Software Engineering Practices, quality assurance technologies, and the regulatory requirements in the life science industries. We realize compliance in a timely and cost effective way on behalf of our clients.