Data Integrity and cGMP Services
Maintaining data integrity is an important part in ensuring the manufacturing quality of your medical device. It is crucial in current good manufacturing practices (cGMP), and employees should have the experience and knowledge to properly record and handle data—in order to eliminate any data integrity issues.
RCA’s services include:
- Comprehensive retrospective evaluation of the nature of the data integrity deficiencies
- Perform a risk assessment
- Identification of deviations and root cause
- Implementation of appropriate corrective and prevent actions
- Assistance with performing forensic electronic audit trail examination of both manufacturing and QC-generated data
- Addressing out of specification (“OOS”) investigation and reporting failures
- Support with addressing open observations
- Training
- Good Documentation Practices (GDP)
- Good Manufacturing Practices (GMP)
- Investigations
- Corrective and Preventive Action (CAPA)
- Project Oversight
