Validation, Audit, And Technical Management Services
PSC shall complete the following tasks as part of the validation and engineering support for the client, the key deliverables of this project included:
Computer System Validation (CSV) Services
Computer System Validation (CSV) is the process of providing documented evidence that a computer system performs exactly as intended. The goal of this project has been to provide ongoing computer system validation services to the client, covering a wide range of enterprise and desktop applications.
Software Validation
The goal of this project is to provide computer system validation (CSV) services for software developed and commercialized by the client.
Technical Writing For San Francisco Biotech Company
PSC Biotech helps the client by generating and completing new SOPs as well as reviewing, updating and completing pre-existing SOPs for their facilities and laboratories. Examples of the SOPs that need to be developed include:
Full-Service Application Management And Technical Support
PSC Biotech support the client by providing high quality, high value application services that ensure client’s application platform evolves to support their changing business priorities. Some of the deliverables of the project include:
Facility GMP Audit Services
PSC Biotech executed a 2-day GMP audit in compliance with 21 CFR 211 and 21 CFR 212. A PSC Senior Auditor performed the audit, prepped, and generated a comprehensive report of the project.
