Cirrhus9′s Qualification and Validation

Quality Assurance and compliance issues can be major pain points for every life science organization. IT and QA organizations typically find themselves in conflict due to the lack of structured procedures and processes, incomplete understanding of a companies risk tolerance or simply the lack of familiarity with the business drivers behind FDA compliance.

Cirrhus9 has FDA Qualification and Validation subject matter experts that can support a company’s compliance needs from assessment to implementation.

Working with the applicable regulatory requirements (21 CFR Part 11, SOX etc.) and the client’s own risk-based approach, Cirrhus9 can perform qualifications of infrastructure, hardware, and networking. Our deliverables include custom policies and procedures, client training and exhaustive knowledge transfers to maintain continued operational compliance.
The C9 validation services range from processes and procedure creation for validation all the way through to the actual implementation of a validated application.