In 1997 the industry became regulated by the FDA’s Code of Federal Regulations (CFR) Title 21 Part 11: Electronic Records; Electronic Signatures (commonly known as 21 CFR Part 11).

    In 2003, the FDA provided additional guidance for the industry industry titled Part 11, Electronic Records; Electronic Signatures — Scope and Application.

    Despite this and other relevant publications, the regulated industry and its vendors often struggle with identifying and implementing the most effective and defendable Part 11 controls.

    RCM has been providing a broad range of solutions and services relevant to Part 11 compliance since the initial regulation issuance in 1997, including, but not limited to, the following:

    • Regulatory Compliance assessments and audits, including Part 11 compliance
    • Implementation of specific Part 11 compliance controls
    • Specific focus on Part 11 technical controls (for IT organizations)
    • Specific focus on Part 11 procedural controls (for system user organizations)
    • Part 11 training at “as needed” level of detail, from overview to highly detailed
    • Initial deployment and improvements of IT Compliance programs
    • Systems verification and issuance of system specific “Part 11” certificates 
    • Etc.

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    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.