Eutech Validation specialises in computer systems validation (CSV) - providing quality assurance reviews and supporting frameworks that are concise, consistent, clear and easy to use.
Eutech Validation provides consultancy across all aspects of computer systems validation for a wide range of systems. Our consultants have particular expertise in:
- Validation systems master planning - including assessing and defining risk-based approaches to validation that are cost-effective and appropriate to the system, criticality and client.
- GAMP - providing active participation in ISP/GAMP seminars and forums. We were early adopters of a risk-based and pragmatic approach to CSV and managing director, Per Olsson, is the founder, leader and editor of the GAMP guide for Electronic Data Archiving.
- Electronic records and signatures - creating training and templates for managing the implications of 21 CFR Part 11 for electronic records and signatures (ERES).
Training - creating and delivering training courses covering all aspects of CSV and quality-related matters including GAMP, ERES and SOPs.
- Audits - performing internal and external audits using our bespoke Eutech Validation questionnaires and GAMP to meet client requirements. Source code reviews (PLC and DCS) are also carried out.
- Quality assurance - creating CSV and quality frameworks to suit client needs as well as reviewing existing frameworks. We also offer our own simplified quality farmework - SD Lite.
"Eutech Validation provides computer systems validation for a wide range of systems"