Verification, validation, qualification
As a manufacturer or supplier in a regulated market environment, you have to comply with numerous requirements set by law. And that’s a good thing, because the ultimate goal of these requirements is to ensure the quality and safety of manufactured products, and in this way to protect the user. HEITEC assists and supports you in complying with legal guidelines using a comprehensive approach – from consulting and employee training, through design and planning, to implementation and execution.
Our experienced employees assist you in every phase of validation with specialized expertise in the relevant sectors. Their systematic, risk-based approach takes into account all contingencies and so guarantees the highest standard. This also allows us to ensure efficient project execution and regulatory compliance.
- Design and planning
- User specifications books
- Risk analyses
- Functional specifications
- Design specifications for the system
- Detailed specifications for hardware and software configuration
- Compliance with Good Manufacturing Practice (GMP)
- Certified quality management system (9001, 13485)
- Regulatory requirements: 21 CFR Part 11, Annex 11, Annex 15
- GAMP 5 guidelines
- Verification (testing)
- Installation and system setup (IQ)
- System functionality (OQ)
- Measuring instrumentation and process capability tests
- Software validation
- Cleaning and sterilization validation
- Automated testing
- DORA (Data Organization Report Automation) – Creation and administration of qualification documents
- HeiMAX TestRunner – Test automation at module and I/O level for automation software
- HeiMAX – Q – Digital performance and logging of qualification and validation tests