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21 CFR Part 11 - Electronic Records/Signatures

During a typical manufacturing process, various measurements are taken to ensure product quality. These measurements associated with manufactured lot numbers are stored within the manufacturer’s information system. At this point, the measurements become electronic records, collectively with other records, for a Device History Record.

21 CFR Part 11 Electronic Records/Signatures

In a typical measurement system, calculation parameters, and at times raw data and calculated results, are stored as electronic records for retrieval at a later time. Regulatory bodies such as the Food and Drug Administration (FDA) require that electronic records and electronic signatures comply with 21 CFR Part 11 – a compliance policy designed to establish controls to ensure electronic records and signatures are:

  • Legally effective and valid
  • Acceptable for meeting the FDA’s recordkeeping and submission requirements
  • Valid for use in lieu of paper records and handwritten signatures

Proper application of available technology and proper system design are key to ensuring that electronic records meet the requirements of 21 CFR Part 11:

  • Systems used to generate, store and maintain electronic signatures must ensure that data is trustworthy and reliable
  • Electronic signatures must be difficult to repudiate by individuals who sign records
  • Data must not be easily altered using backdoor applications without leaving an appropriate audit trail

Konnexis software solutions include regulations and policies which are fully compliant with recordkeeping requirements of the FDA statute. Some requirements implemented are:

  • Validation – systems must be validated as per the requirements of 21 CFR Part 20 and per General Principles of Software Validation; Final Guidance for Industry and FDA Staff
  • Availability – records must be available for review or audit
  • Retention – records must be available for the retention period dictated by the product being processed
  • Audit Trail – system must proved a secure and independently generated audit trail of any actions that create, modify or delete records.
  • Sequence – system must ensure proper steps are followed
  • Authority Checks – privilege based security ensures operator has appropriate privileges to perform a specific function

21 CFR Part 11 Compliant Report

21 CFR Part 11 compliant electronic signatures are applied to various documents including:
  • Receipts
  • Specification Approval Process
  • Shipping
  • Certificates of Processing

21 CFR Part 11 Compliant EO Results Report

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