EO Control Systems Gamma Control Systems Sterilization
 
 

Electronic Signatures

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 ethylene oxide results

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

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