Computer System Validation Training

PharmOut are specialists in Computer System Validation and can train your personnel to validation all of your computer systems to attain regulatory compliance.

We advocate the use of the ISPE guidelines, like GAMP 5, in particular the V model and we will train students on laying out the information in a simple manner that has a built in Requirements Traceability Matrix, RTM.

These Specifications a essential documents which are verified by the Qualification Protocols.

The training course focuses on starting with a Validation Plan, User Requirements Specification (URS), developing Functional Specifications (FS) and Detailed Design Specifications (DS).

Our Trainers can train your personnel in the areas of:

Writing Validation Plans and Specifications.
Documenting Design Reviews.
Risk Assessments.
Creation and execution of protocols, Installation Qualifications and Operational Qualifications.