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21 CFR, Part 11

AVS has expertise in Part 11 ER/ES Ruling interpretations and electronic data applications as pertaining to Pharmaceutical, Biotech and Medical Device industries' data acquisition, Electronic Batch Record, Audit Trail, Closed and Open Systems. We can provide expertise to perform system inventory, evaluation and re-mediation to bring systems into compliance with Part 11.

This includes:

  • Project Strategy and Planning
  • Team Selection
  • System Evaluation
  • Guidelines/Requirements
  • Develop Action Plan
  • Implement Corrective Action
  • Testing
  • Final Report

Part 11 Definitions and Summary:

  • Electronic record - Any information (text, graphics, data, audio, pictorial objects) created, modified, maintained, archived, retrieved, distributed, or reported by a computer system.

  • Electronic signature - A computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be legally binding equivalent of the individual?s handwritten signature.

  • Qualification - To provide a high degree of accuracy, authenticity, integrity, confidentiality, reliability and consistency to generate, record, archive, maintain and electronically approve cGMP records.

  • Firms are required by the ruling to establish adequate control measures to ensure the integrity of system operations and information stored: 1) Validate 2) Generate complete and accurate copies of records 3) Archive protection 4) Use Time-Stamp audit trail 5) Educate and train individuals who use ER/ES systems.

 
 

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