Computerized Systems Validation (CSV) is a requirement of FDA 21 CFR Part 11, FDA 21 CFR Part 820, EU EudraLex Annex 11, and other regulations. CSV is widely acknowledged as an effective and prudent business strategy as well as a regulatory requirement.

    Despite availability of such guidance documents as FDA’s General Principles of Software Validation; Final Guidance for Industry and FDA Staff and ISPE GAMP5, the costs of validation fluctuate wildly depending on the practices adapted by individual regulated organizations.

    Computerized systems used by the Life Sciences industry in many areas, including the following, need to be validated:

    • Manufacturing and laboratory environments
    • Enterprise governing
    • Quality assurance systems
    • Documentation control
    • Etc.

    RCM specialized in providing CSV and System Verification (Testing) services. Our services include:

    • Hands-on Computerized Systems Validation,
    • Staff augmentation at all levels of experience and responsibility
    • Establishment and deployment of GAMP5-driven Risk-Based Approach to Validation practices
    • Vendor-Client relationship management during CSV efforts
    • Initial system deployment validation
    • Change controls of validated systems
    • Assessment of current system compliance and validated state
    • Etc. 

    Start With a Phone Call

    Speak with one of our SME's. The result may be: 

    • Advice 
    • Free Consultation 
    • Gaining a trusted advisor and networking partner

    Our offerings are as flexible as our clients’ needs and range from staff augmentation to
    scalable turn-key solutions and we look forward to hearing from you.