We provide high-quality validation life cycle services for equipment, facilities, and utilities in pharmaceutical, biologics, medical devices, diagnostics, consumer products, cosmetics and veterinary industries. Our experience includes projects ranging in size from qualification of a single piece of equipment to complete turnkey validation of the equipment, facilities, utilities and processes in a start-up facility. We have expertise in the qualification of classified environments, containment solutions, clean utility systems and highly complex process equipment. We provide reliable and expert resources and deliver quality solutions.
Our experience in temperature mapping allows us to offer our customers a wide range of services. We have experience mapping extreme temperature environments such as cryogenic environments and tunnels as well as more usual equipment such as autoclaves, warehouses and stability cabinets. We perform temperature-mapping studies utilizing Kaye Instruments metrology equipment. The Kaye application software can be configured to perform data calculations such as minimum, maximum, average, lethality, etc.
In what ways can PSC Biotech help with my validation life cycle?
We can advise you on industry trends and best practices or, if you have established methods and protocols, we can tailor our services to suit. Whether it is executing a client’s protocol or executing a protocol that has been custom produced by PSC Biotech, our validation engineers provide quality on-site protocol execution services. We have expertise in GMP documentation practices and change control procedures. We understand the importance of following SOPs. Our approach can deliver substantial improvements in compliance while minimizing down time and maintaining the highest assurance of product quality and safety.
- Installation Qualification (IQ) demonstrates that equipment is installed according to pre-determined specifications correct installation and configuration of software and hardware as documented in the Design and/or Configuration Specifications (DS/CS)
- Operational Qualification (OQ) demonstrates that equipment operates according within specified operating ranges as defined in pre-approved specifications
- Correct operation of software functionality throughout operating ranges as defined in the Functional Specification (FS)
- Performance Qualifications (PQ) demonstrates that equipment performs as intended according to pre-approved specifications, and that software performs as per its intended use, as defined in the User Requirements Specification (URS)
The diagram shown below depicts the validation life cycle for equipment and computerized systems.
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