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Computer System Validation Services......................

Computer System Validation

We provide consultancy services for a wide variety of computer system validation projects, ranging from validation planning through to execution. We have experience in most system types including LIMS, Laboratory instrumentation, buiness and quality managemnt systems, databases and SCADA.

Validation Master Planning

We specialise in planning and defining risk based approaches for computerised system validation. We recognised the critcal need of tailoring the validation strategy to reflect the system type and its application. We can help integrate pragmatics approaches into your quality managemnt systems.

GAMP

We have been actively involved with GAMP from the offset, firstly through Eutech, and then through ABB. We have provided training courses on GAMP worldwide and have been speakers at the GAMP forums.

Training

We can provide training courses on a wide variety of computer system validation topics, including GAMP, 21 CFR Part 11, GMP Awareness and Quality Managemnt Systems. We provide regular industry conferences for FDA News and also partner with Eutech Validation for training courses.

Audits

We undertake a variety of internal and external audits for clients. Our audits can be based upon industry standard approaches such as GAMP or based upon specific client requirements such as supplier assessment or pre-inspection audit.

Quality Management Systems

Use our pre-developed documents, or adapt them into your own quality system. Ranging from a full suite of QMS SOPs, through to detailed specifications and comprehensive qualification documents bring your QMS and validation up to scratch with minimal workload.