All computerized systems and all connected devices and/or instruments used in regulated environments must be verified. The CSV compliance process is focused on verifying the development process, system and infrastructure qualifications, systems functionality integrity, and specification consistency. It also requires QA to have end-users verify the system meets their business needs, they are trained, and all SOPs have been verified and approved.
Whether the system being implemented is built internally or sourced from a vendor, the requirements are the same. All phases of the system life cycle require well thought out documentation detailing system requirements, design verification, system testing verification, and readiness to support implementation. If purchased from a vendor, requirements must be verified by examining the vendor’s processes and supporting information for CSV.
Our Approach
RegDev takes an education-first approach and partners with clients to tailor solutions that fit their needs and goals. Our industry-expert consultants possess a strong technical foundation and can help implement and maintain IT processes and CSV. We work proactively to meet the current needs, but also provide built-in flexibility to allow clients to pivot when necessary.
IT PROCESSES
SYSTEM QUALIFICATIONS
21 CFR PART 11
SENSITIVE DATA SECURE
SYSTEM REQUIREMENTS
END-USER VERIFICATION
IT IMPLEMENTATION
IT teams generally implement computerized systems and must understand computer system validation for the CSV process. By implementing IT Processes and CSV and remaining in compliance when implementing or maintaining systems, they help support the organization. RegDev’s technical experts provide a foundation for the CSV process.
ONGOING COMPLIANCE MAINTENANCE
CSV verifies compliance with CFR Part 11 for electronic records and signatures. This compliance must be maintained throughout the life of the system. Maintenance needs to be ongoing, and end-users need to be involved in user acceptance testing. RegDev has years of deep experience with validation testing and can help with the development and maintenance of CSV verification processes.
PROACTIVE PLAN FOR COMPLIANCE
It’s beneficial to start planning for CSV before a system has been put in place. As an organization matures and their systems expand, so do the requirements for compliance. RegDev’s proactive planning can help shape how to develop a thoughtful and thorough CSV process and maintenance plan.
Testimonial
“Sid and his experts were instrumental in assisting in the conduct of GMP and GCP risk assessments, the design of mediation plans,
and their participation in the oversight of the execution of such plans. This work has led to both successful PAI inspections, NDA approval, and allowed each company to target vital internal resources on the endgame.”
