Validation & Documentation
 
We are conversant with all stages of the GAMP validation life cycle of automated control systems and can provide on-site assistance in mananging it. We have experience in creating change control procedures for automated systems and have developed a complete Management of Change infrastructure for a large  multi-national company at the request of the HSE.
 
Documentation is often an afterthought in Process Control and this can lead to poorly specified and hence poorly designed control systems. Having spent many years working in an FDA / GAMP environment we have become known for to providing high quality, detailed documentation for all phases of a project life cycle on systems designed by ourselves as well as those designed by others. Our knowledge of software design, process control and process dynamics and GAMP Validation allows us to ensure that the documents are worthwhile and improve the robustness and supportability of the system in the long term.
 
A brochure is available for this service, please go to our downloads page to obtain one in PDF format.
     
Requirements Documents Specification Documents Review Documents

Tender Documents

Validation Plans (VP)

User Requirements Specifications (URS)

Software Requirements Specifications (SRS)

Functional Design Specifications (FDS)

Hardware Design Specifications (HDS)

Software Design Specifications (SDS)

3rd-PARTY Code Reviews

Test Documents / Reviews

Traceability Matricies

Validation Reports (VR)

Disaster Recovery Procedures

Standard Operating Procedures (SOP)

Risk Assessments

Change Control Procedures

HSE Management of Change