Quality Assurance Consultancy assists regulated companies with electronic records and electronic signatures support.

Our specialists can help you evaluate your level of compliance with the Electronic Records, Electronic Signatures (ERES) requirements of the 21 code of federal regulations (CFR) Part 11 – providing support with:


  • Evaluate existing systems
  • Gap analysis to Part 11 and to Predicate Rule

Computer System Validations

  • Validate standard operating procedures (SOP)
  • Conduct master validation plans
  • Conduct testing validation plans
  • Audit testing results


  • Conduct electronic signatures introductory seminars
  • Conduct electronic records introductory seminars