Services
Computer System Validation (CSV)
Computer System Validation (CSV) in the life sciences presents a significant challenge as it requires compliance with a wide range of regulatory requirements. FDA, ISO 13485, GMP guidelines or GAMP 5 require strict standards to ensure the integrity and reliability of computer systems in production. These regulations require comprehensive documentation, risk assessments and regular audits to ensure that systems operate consistently and safely. This requires a deep understanding of the regulatory landscape as well as continuous training and adaptation to keep pace with ever-changing regulations. This is a complex but essential task for companies.
With experienced validation experts and a methodical, risk-based approach - in line with the GAMP5 guidelines - we systematically tackle your challenges.
Our solutions have proven themselves in many projects and our methods are constantly being improved. We support you in the validation of your computer systems in the highly regulated environment of the life sciences industry.
Strategic changes
- FIT/ GAP analyses of existing systems and IT service processes, definition of corrective measures
- Checking, correcting and setting up the necessary CSV guidelines and templates in the IT service process
- Suggestions for improving the validation system (lean validation)
- Audit preparations (e.g. FDA, authority or customer audits)
- IT audits for our customers at suppliers
- Validation project management
- In-house training courses
Prospective validation consulting and support for the introduction of software systems
- IT-supported business processes, e.g. ERP, CAQ, DMS
- LIMS for laboratory processes and automation/control of laboratory equipment
- MES /SCADA /SPS in production
- Track & Trace solutions
- Excel spreadsheet validation
Validation of non-validated legacy systems for
- change in regulatory requirements
- change in business model, addition of products or new markets
- merger/demerger situations
Other solutions
- IT infrastructure qualification
- Re-validation for release changes
- CAPA, EBR, intranet, cloud-based applications
Relevant Projects
If you have any questions about computer system validation, please contact us
We help you to successfully implement your project.
With professional computer system validation in GMP-regulated areas. Get in touch with us.