Pharmaceutical Validation Support
Omega offers reasonably priced validation services that are designed especially for the Pharmaceutical Industry and are in accordance with Gamp Validation Methodology.
Validation Package
Omega offers a Validation Package that many of our clients find an efficient and time-saving resource. This package includes a Functional Specification (FS) and a basic test document, which can be prepared as one (or more, as an option) 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. The documents are created in Omega's format and delivered to the client as Microsoft Word (.doc) and Adobe (.pdf) files. Clients are encouraged to modify, expand and re-use these documents on the projects for which they are supplied.
Additional Validation Support
- Protocol execution support
- Custom commissioning and qualification documents
- Detailed, illustrated Operation and Changeover Procedures (SOP)
- Training, training documentation, and training assessment