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Medical Device Industry - FDA CFR 21 Part 11 - Electronic Signatures


The Food and Drug Administration regulation FDA 21 CFR Part 11 governs the use of electronic records signatures in adherence to current good manufacturing practices, referred to as cGMP, for the life sciences, pharmaceutical and biotech industries.  Depending on the software under development, adherence to FDA 21 CFR Part 11 within the organization may be very strict and require a very literal interpretation.  The more life-critical the software (such as embedded software in a pacemaker) the more stringent the requirement.  This regulation fits into an overall program for computer validation that exists within life sciences companies.

Companies where MKS Integrity is aiding with FDA 21 CFR Part 11 compliance include:

The following MKS Integrity capabilities directly support FDA 21 CFR Part 11 compliance:

  • Automated workflow - MKS Integrity's flexible automated process and workflow management establishes and enforces policies that hold individual users accountable and responsible for their activities, ensuring the appropriate sequencing of steps and events and the confidentiality of records where appropriate. It also provides organizations with a granular means to limit access to artifacts and process by project, role or user
  • Server side auditing and audit trails - The MKS Integrity server generates secure and time-stamped audit trails to record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes do not obscure previously recorded information, and the organization can establish the length of time such audit trail documentation is retained and it is easily available for agency review and copying
  • Roles based security and approval - With support for enterprise access and directory services such as Microsoft Active Directory or other LDAP based systems combined with its flexible role and project based user access control mechanisms, MKS Integrity meets the regulatory requirement to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output devices, alter a record, or perform the operation at hand
  • e-Signature support - e-signatures can be applied at any step or stage in workflow requiring approval or authorization. In accordance with section 11.50, MKS Integrity records the name of the signer, the date and time when the signature was executed and context of the signature, such as review, approval, responsibility, or authorship. The signature can also be produced in a human readable format in the history of the artifact.


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