Compliance with 21 CFR Part 11 / Annex 11 (ERES)

Part 11 or Annex 11 defines the regulatory requirements for Electronic Records and Electronic Signatures (ERES) in the Healthcare Industry.

Simple, compliant Computer System Validation solutions

PharmOut are specialists in Computer System Validation and can assess your computer systems, or proposed computer system, against the predicant rules. We will then recommend any remediation required to comply with 21 CFR Part 11 or Annex 11 requirements.

A common mistake is to ignore the predicate rules and incur unnecessary expense in areas where it is simply not needed. The FDA recently, after consultation with industry and the ISPE, released an updated risk-based guidance document. In spite of the release over three years ago it is still common practice to over-elaborate this requirement.

Pharmaceutical and Medical device - Part 11 Compliance

We have Part 11 compliance procedures, assessment templates, ensuring that you have the documentary evidence to ensure compliance with the CFR's and Regulatory Requirements and ensuring that you pass your next South African MCC, UK MHRA or US FDA audit.