Services
What We Do
Seydel Consulting offers your company high-quality services within the framework of computer system validation (CSV) in the pharmaceutical environment.
Through many years of experience, we offer your company the best possible solution to everyday and special challenges.
Seydel Consulting not only provides services in the regulatory environment but also technical understanding and analytical skills to find the best solution for the challenge to be faced.
In our philosophy, a validation service is not without technical understanding. In order to promote this understanding, we select our employees according to both technical and validation comprehension.
Computer System Validation
Today computer-assisted systems play a central role in the development and manufacture of medicinal products and medical devices. If such a system is used in critical business areas, the company must provide the documented proof that the system operates according to predefined specifications and also fulfills these in everyday operation.
In industries such as the pharmaceutical industry and medical technology, which are subject to health-related regulations (GxP), this is ensured by the validation of computer-assisted systems (CSV) according to industry standards (eg GAMP 5, FDA Guidelines, PICs). The term CSV covers various topics of the validation and qualification of computer systems, from the software application through the IT infrastructure to the system control and auditing.
The validation of these systems is an integral part of the System Development Life Cycle (SDLC), without the risk that deviations will be found at a later stage within the project (between the rules and the delivered solution). The validation process provides the documented proof that the system meets the specifications throughout the entire life cycle.
USA FDA 21 CFR, Part 210, 211 and 11, Volume 4 Annex 11 and EU GMP describe the requirements that a computer-controlled system must meet. The rules apply to any computer system that generates data that is used to transfer quality assessments or report to the FDA.
Technical Support
GLP-compliant work requires inter alia. A complete documentation and traceability of the analytical results and the monitoring of their quality. We supported you in a comfortable way. We support you in qualifying and validating your devices, methods and processes. We not only provide you with comprehensive documents such as: Installation qualification (IQ) and operational qualification (OQ). The user can also have these services performed by our trained specialists.
This guarantees you high reliability with regard to correctness and reproducibility of your measurements.
Practice Areas
Validation Documentation
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User Requirements Specification
- Project Plan / Validation Plan / Decommissioning Plan
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System Certification Summary / System Decommissioning Report Summary
Technical Documentation
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Functional Requirements Specification
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System Architecture Description
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System Description
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Code Review Documentation
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Configuration Item Inventory
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Software Installation Qualification
System Testing
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Validation Test Protocol (Regression Test i.e. Business Cycle Test, Unit Test)
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Test Summary