Pharmaceutical Validation Support
Omega offers reasonably priced validation services that are designed specifically for the Pharmaceutical Industry and are in accordance with Gamp Validation Methodology.
Omega's Validation Packages are an efficient and time-saving resource for many clients. The base package consists of a Functional Specification (FS) and a basic test document, which can be prepared as one of the following:
- Factory Acceptance Test (FAT) Protocol
- Site Acceptance Test (SAT) Protocol
- Installation and Operational Qualification (IQ & OQ) Protocols
The Validation Package includes documentation only. Note that the documents are created using Omega's formatting and delivered to the client as Microsoft Word (.doc) and Adobe Acrobat (.pdf) files. Clients are encouraged to modify, expand and re-use the content in these documents to fit their own needs and protocols.
Additional Validation Support
- Protocol execution support
- Custom commissioning and qualification documents
- Detailed and annotated Standard Operating Procedures (SOP)
- Training, training documentation, and training assessment