EXCO - Your Certified Partner for Risk-Based CSV and Regulatory Compliance
We validate your IT systems (CSV) and ensure that your computer systems or software applications in highly regulated industries (e.g., medical technology, pharmaceuticals, life sciences) function correctly and comply with legal and regulatory requirements. Our EXCO Validation Services cover all necessary validation activities - from developing the validation strategy to coordinating and executing validation activities, as well as assessing regulatory compliance and identifying opportunities for optimization.
In addition, we offer process validations and customized workshops for your quality professionals, as well as complete Scrum teams. Together, we establish the foundation for compliant development processes and effective validation activities aligned with your organizational needs.
Services
EXCO Validation Services
Strategy & Planning - CSV
With the right validation strategy, we ensure that your systems meet the required quality and compliance standards. We develop a tailored, risk-based validation strategy and integrate it into your quality management system while taking all applicable regulatory requirements into account, including requirements for Electronic Records and Electronic Signatures (ERES).
Our services:
- Risk management, including risk assessments
- Requirements management, including support for agile development environments
- Review and test management
- Regulatory compliance and conformity assessment
Project Management & Coordination - CSV
EXCO manages all validation activities on your behalf, from project leadership and coordination through to the complete preparation of validation documentation, in accordance with the applicable standards and regulatory requirements of your industry.
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 and 15, US FDA CFR - Code of Federal Regulations Title 21, Part 11, Part 210 and Part 211, ICH E6 (R2) Good Clinical Practice, DIN EN ISO 13485, GAMP® 5.
GxP-Compliant Implementation
Validation activities play a central role in quality assurance in the pharmaceutical, medical technology, and life sciences industries. EXCO supports you in the practical implementation of all validation measures to ensure that your software meets regulatory requirements and is suitable for its intended use.
Our services:
- Configuration and validation of GxP-relevant systems (e.g., QMS, LIMS, ERP)
- Validation of no-code and low-code solutions
- Validation of cloud-based and on-premises systems
- Creation and review of requirements documentation
- Test management, including planning, execution, and documentation
- Compliance with regulatory requirements, including EU GMP Annex 11 and 15, FDA CFR Title 21 Part 11, ISO 13485, the EU AI Act, and GAMP® 5
Compliance Assessment - CSV
Validation is an important prerequisite within the conformity assessment process. It ensures that your software meets the defined requirements and can be approved.
Our services:
- Conducting gap analyses
- Complete, audit-ready documentation
- Workshops on optimization opportunities
- Regulatory consulting
EXCO's Quality Standard
Certified by TÜV SÜD to EN ISO 13485:2016 and DIN EN ISO 9001:2015
EN ISO 13485:2016 - The Provision of Design and Development Services for Components, Semi-Finished Products and Manufacturing Processes for Medical Devices and In Vitro Diagnostics. The Provision of Development Services and of Testing and Production Equipment for the Manufacturing of Medical Devices and In Vitro Diagnostics, including Robot-Based Physical Testing for Use within Product Development, Verification or Validation Activities. The Provision of Regulatory Affairs Services for Medical Devices and In Vitro Diagnostics. The Provision of Qualification and Validation Services for the Manufacturing of Medical Devices and In Vitro Diagnostics.
DIN EN ISO 9001:2015 - Design and development of components, semi-finished products, manufacturing processes, software as well as production of test and production equipment as well as provision of services in laboratory analysis
EXCO Sevices
EXplore our EXCO Services
As a full-service provider, we support SMEs and large corporations with high-quality technical solutions in software engineering, systems development, automation, and quality assurance for highly regulated markets. Our customers include companies in the medical technology, pharmaceutical technology, biotechnology, chemical, and food technology sectors, as well as other regulated industries.
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