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 CFR Part 11 –providing support with:
Assessments
- Evaluate existing systems
- Gap analysis to Part 11 and to Predicate Rule
Computer System Validations
- Review standard operating procedures (SOP)
- Prepare master validation plans
- Prepare testing validation plans
- Execute validation test scrips
- Audit testing results
Training
