Computer System Validation (CSV)
We validate your IT systems (CSV) to ensure that your computer systems and software applications in highly regulated industries (e.g. medical technology, pharmaceuticals and life sciences) function correctly and comply with legal and regulatory requirements. Our EXCO Validation Services cover all necessary validation activities, including developing the validation strategy, coordinating and implementing validation activities, assessing regulatory compliance, and identifying areas for optimisation.
We also offer individual workshops for your quality specialists and complete Scrum teams, teaching them everything they need to know about designing development processes and carrying out validation activities.
EXCO Validation Services
Strategy and Planning
We ensure that the systems used meet the required quality and compliance standards by implementing the right validation strategy. We develop an optimal, risk-based validation strategy tailored to your needs and integrate it into your quality management system (QMS), taking into account all regulatory requirements, including those relating to electronic records and electronic signatures (ERES).
Our services:
- Risk management, including analysis
- Requirements management - also in agile environments
- Review and Test management
- Compliance with regulatory requirements
Guidance and Coordination
EXCO handles all validation activities for you, from project management and coordination to complete document creation - in accordance with applicable standards and guidelines.
Our services:
- Project management
- Test management
- Validation documentation (e.g. traceability matrix).
- Validation processes
Standards and guidelines: EU EudraLex - Volume 4 - Good Manufacturing Practice (GMP) Guidelines, Annex 11 und 15, US FDA CFR - Code of Federal Regulations Title 21, Part 11, Part 210 und Part 211, ICH E6 (R2) Good clinical practice, DIN EN ISO 13485, GAMP 5.
Implementation
In the pharmaceutical, medical technology and life sciences industries, validation activities play a central role in quality assurance. EXCO supports you with the practical implementation of all validation measures, ensuring that your software meets regulatory requirements and is appropriate for its intended use.
Our services:
- Configuration and validation of GxP-relevant systems (e.g. QMS, LIMS and ERP)
- Validation of no-code/low-code solutions
- On-site validation of cloud-based or on-premises systems
- Creation and review of requirements documentation
- Test management, including planning, execution and validation documentation
- Ensuring compliance with EU GMP Annexes 11 and 15, FDA CFR Title 21 Part 11, ISO 13485, EU AI Act and GAMP 5
Compliance Assessment
Validation is an important milestone in the compliance assessment process. This confirms that your software meets the specified requirements and is eligible for approval.
Our services:
- GAP analysis
- Complete, audit-ready documentation
- Workshops on optimization potential
- Regulatory consulting
