Computer System
Validation
Ensure your computer systems meet stringent regulations with Agidens’ Computer System Validation services, guaranteeing continuity, reliability and data integrity. We can provide support tailored to your needs to help you achieve your goals.
Our experts are familiar with the refinements and details of the relevant regulations, guiding you safely to your objective. Our expertise is based on many years of successful implementation and validation of GxP-CSV projects for both on-premises and cloud-based systems, such as ERP and MES.
COMPUTER SYSTEM VALIDATION (CSV) & GAMP 5
Agidens efficiently supports you in implementing the requirements for computer system validation (CSV) in GLP (Good Laboratory Practice), GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), and for medical devices.
In the area of GCP, GMP, and GDP, the ‘Good Automated Manufacturing Practice 5’ (GAMP 5 & GAMP 5 2nd Edition) guide by the International Society for Pharmaceutical Engineering (ISPE) is widely recognized as a guideline for practical implementation.
The complexity and criticality of the system determine the specific checks within the overall validation process, which are assessed through a risk-based approach.
The ultimate guide for taking a thorough and structured approach to CSV is undoubtedly ISPE’s GAMP5. These guidelines describe procedures and principles by which you can demonstrate that your pharmaceutical products are continuously of the highest quality. This is only possible if you validate all stages in the production process. Moreover, the guidelines apply to any computer system that generates data used to make quality decisions or report to the Regulating Authorities.
AGIDENS IS YOUR PARTNER FOR CSV
Agidens is your dedicated partner for CSV. We offer an end-to-end support and expertise to ensure your operations are consistently reliable, accurate and compliant.
Our approach to CSV involves a meticulous process that covers every aspect of ensuring reliability and compliance according Gamp 5 (2nd edition), ISO 13485 and Data Integrity, whether your software is an on-prem or a SaaS (Software as a Service) system.
Assessments
Our experts conduct thorough assessments of your computer systems, identifying gaps and defining a remediation approach
- DI (ALCOA)
- CSV
- Computer System Assurance (CSA)
- GxP Criticality
- EU regulations (EudraLex Vol 4 Annex 11)
- FDA regulations (USA FDA 21 CFR Part 210, 211, and 11)
CSV
As part of our services, we provide all the necessary deliverables to ensure complete Computer System Validation.
- VMP & VP
- Risk assessments
- URS
- Protocols IQ, OQ, UAT (incl. execution)
- Reports
- Traceability matrix
- VSR
- Periodic review
Services
We tailor our support to meet your needs.
- Full scope projects
- High-level support
- Engineer at your site in support of an existing team
- Managed Service Team (MST): a team at your site that provides a full package service
- SOP and WI creation / Update CSV based
Training
Our experts are ready to offer training initiatives at your site or in our facilities, covering various topics and not limited to the following list.
- Data Integrity
- Gamp 5 and Gamp 5 2nd Edition
- CSV (Computer System Validation)
- GDP & ALCOA
- Audit Trailing
- Excel Validation
TAKE YOUR CSV TO
THE NEXT LEVEL
Can you appreciate our approach? We are already curious to hear what you have to say. Make sure to let us know by filling in the contact form.
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