Regulatory-compliant validation of processes and methods
EXCO Consulting in Lucerne supports manufacturing MedTech and pharmaceutical companies in the regulatory-compliant validation of processes and methods - ensuring that reproducibility, reliability, and regulatory compliance are documented and verifiable.
Regulatory requirements such as EU-GMP, Annex 15 - FDA Guidance for Process Validation - GDP Guidelines - ISO 13485 demand documented evidence that all critical processes operate under controlled conditions. The validation services of EXCO Consulting GmbH include the planning, implementation, and documentation of:
- Process validation: Evidence that manufacturing processes for pharmaceuticals and medical devices deliver consistent results
- Cleaning validation: Ensuring the cleanability of systems, equipment, and product contact surfaces
- Transport validation: Verification of transportation routes and conditions for temperature-sensitive products
- Method validation: Validation of testing methods to ensure analytical accuracy and precision
- Creation of all necessary validation documents such as VMP, VP, risk analyses, test plans, and reports.
Our validation strategies are risk-based, practical, and compliant with regulations – for safe products and stable processes.
More conformity with EXCO Consulting
Our experts have extensive experience in validating manufacturing processes, cleaning procedures, and testing methods. We work closely with your teams to accurately capture and efficiently implement validation-related requirements. EXCO stands for structured validation projects, complete traceability, and seamless documentation – ensuring that your processes meet all requirements and pass audits and inspections with confidence.
