CSV and GxP Compliance: Expensive but vital?
Validation of computerised systems according to GxP Guidelines (CSV) has been a basic requirement in the life sciences industry for many years. However, as the complexity in the IT landscape and the degree of automation has increased significantly, the costs for compliance have risen disproportionately over the last few years and against a background of mounting pressure to reduce healthcare costs for the long term. Validating computerised systems (CSV) is crucial to patient safety. But how much does and how much can validation cost?
Nevertheless, the outlay for validating computerised systems can be reduced significantly for both suppliers and for the life science industry, if the right strategy and an implementation that is tailored to compliance requirements and to your needs and processes are used. The NNIT consultants will support you here not only as experts in GxP compliance and validation but also from the commercial aspect of cost efficiency. This is what you can achieve:
- GMP, GLP, GCP compliant IT systems and processes
- The security of working in compliance with FDA and EMA as well as according to current standards (21 CFR part 11, Annex 11, GAMP 5
- Sustainable reduction in outlay and costs for the validation
- Security for internal and external audits
- Validation strategy for implementing the risk-based approach