Validation

Omega offers validation documentation and services that are designed primarily 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.

Validation Support Documentation

Most documentation packages will consist 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

Support documentation is developed for the customer using Omega's formatting. Customers will receive digital files in Microsoft Word (.doc) and Adobe Acrobat (.pdf) file formats. Customers can modify, expand and re-use the content provided to fit their own needs and protocols.

Validation Services

• Protocol execution support

• Custom commissioning and qualification documents

• Detailed and annotated Standard Operating Procedures (SOP)

• Training, training documentation, and training assessment