Data Integrity
Data Integrity (DI) has become a focal point of FDA inspections, as is evidenced by the number of Warning Letters citing data integrity and the resulting number of Import Alerts. Company Quality Management Systems are being scrutinized as to how the integrity of raw data (both electronic and manual) generated in the Quality Control Laboratory and in Operations (Manufacturing and Engineering) can be assured. The FDA is now including recommendations for recipients to obtain 3rd party assistance when addressing DI issues.
An indicator of potential Data Integrity issues are an unreasonably low number of deviations, OOS incidents, EM excursions. We have had more experience than most consulting companies with DI assessments, interviewing current and former employees as a part of investigations, and remediation.
We have developed several DI training courses:
- DI auditing demystified – a 2-day course on how to audit a QC laboratory, using FDA audit techniques
- Conducting DI audits of manufacturing operations – a 1-day course on how to audit Manufacturing and Engineering operations
Remediation
Whether the result of compliance activities by Health Authorities (e.g., Consent Decree, Warning Letter or 483 Inspections) or corporate initiatives, DDC’s services can range from data integrity risk assessments, DI awareness training, DI auditing techniques training, to remediation and re-engineering of electronic data procedures to mitigate risk.
Experience includes risk assessments of data handling systems and procedures (both manual and electronic), remediation (including retrospective reviews), and development and delivery of DI training. Training can be customized for your site.
Records Review
Audit of production and QC records, including laboratory notebooks for good documentation practices, and electronic data generated by analytical instrumentation such as HPLCs, GCs, GCMS, ICP, autotitrators, etc, for Part 11 compliance. Potential sources include batch records, lab instrument software and security, intentional sample mislabeling, retesting of samples into compliance, inadequate OOS investigations, and data recording methods.
Experience includes both retrospective and prospective review of batch records and QC release packets, review of automated data capture systems (including audit trails and LIMS systems), computer system security, computer system validation (CSV), review of procedures, actual practices, audit trails, and databases for electronically generated data.
Training
Data Integrity training for Manufacturing and Engineering Operations, QC and QA staff, and internal auditors is critical for effective data integrity compliance and ensures a sustainable solution. Training includes hands-on activities and breakout sessions. Observation by DDC trainers following training is recommended to ensure that training has been effective.
Experience includes development and delivery of interactive data integrity training courses and coaching and mentoring of Quality personnel, investigators, and internal auditors.