ICCON Consulting provides a comprehensive Computer Systems Validation, Analytical Instrument Qualification and GMP Audit services in all stages of the life cycle of your systems. We follow the risk-based GxP principles laid out by PIC/S, ICH, EMA and the FDA, to prioritize the processes and systems to assess.
Our approach to CSV and GMP audits is to provide a positive and pragmatic service which is of optimum benefit to the auditee. A CSV audit involves a review of;
- All related procedures.
- Computer systems validation and qualification documents.
- Operational documentation.
- Operational activities.
- Qualification of the stuff
The objective of the CSV Audits is to assess good computer system management practice, and to verify that the computerized system is validated according to current regulatory requirements such as 21 CFR Part11 and Annex 11.
Before any GMP inspection to your facility, we can immediately begin to address high-risk areas through of SOPs, prospective and retrospective validation, GAP analysis, training, and any other preparation needed for your system compliance audit. Our experts will be working with your team during audit to get you inspection-ready.