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| Specifications |
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Valicare has extensive experience in qualifying and supporting pharmaceutical and bio-tech systems.
We regularly handle GMP requirements, GAMP 5 regulations, Code of Federal Regulations
(e.g. CFR 21, part 11), and a wide range of industry standards.
Our familiarity with these requirements and diverse equipment allows us to compile precise User and Equipment Specification rapidly. Valicare
prepared User Requirement Specifications (URS) or
Functional Specification (FS) and Hardware Design
Specifications (HDS) are always thorough and accurate to the existing or desired system.
Our clear document format and our systematic and pragmatic approach to qualification are
the strengths and are some of the benefits of choosing Valicare to assist with the creation of your specifications.
Another benefit is our ability to use our diverse group of specialist to comprehensively analyse your
system specific technical requirements. We assess the applicable requirements and implications, and transfer this knowledge into clear and concise documents specifying your requirements and the testing to ensure their delivery and successful
operation.
Based on broad experience Valicare is able to break down your process into specific disciplines:
Pharmaceutical process, pharmaceutical quality, mechanical engineering, electrical engineering, automation,
information technology (IT), safety, and operations. Then we analyse each area with a specific technical resource specialised in that discipline’s unique attributes, requirements, and specification methods.
Our specifications can be used for the direct review of all quality relevant aspects of your plant via IQ- or OQ-testing. Following the GAMP V-model we can deduce tests directly from our specifications with the Requirements Traceability Matrix
(RTM) being our linked reference.
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