Validation

Computer Systems Validation (CSV) has become a major area of investment as well as ongoing discussion in the regulated industries. Many users and developers believe that the validation process adds a significant overhead and contributes minimally to the quality of the system and the integrity of its data. The most common cause for poor CSV efforts is the inefficient execution of CSV projects because of varying interpretations of regulatory requirements that focus attention on the style and format of CSV documentation, rather than the ultimate quality of the system.

In light of FDA’s evolving views regarding the value of implementing risk-based approaches , organizations now have the opportunity to reevaluate, improve, and optimize their system life cycle (SLC) and validation methodologies and thus produce better systems more effectively and more efficiently, while ensuring patient safety, data integrity and regulatory compliance.

How Patni Can Help
Patni's computer system validation and 21 CFR Part 11 services formally incorporate a business process-driven, risk-based approach to compliance as an integral part of the SLC to ensure compliance with regulatory requirements. Patni consultants have expertise in regulatory requirements, CSV methodologies, the technical aspects of computer system development, and the surrounding business processes. The team's comprehensive knowledge and experience are essential for effective and efficient scaling and execution of CSV activities. Our senior consultants are experts in managing and coaching developers, users, and validation teams to ensure successful conclusion of system implementation and validation efforts.

Patni's CSV services cover the full system life cycle, from requirements analysis through system retirement, and are fully integrated with complementary business and regulatory compliance services.

Related Patni Services