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Electronic Records and Electronic Signatures

We can help ensure your systems comply with the latest guidance and regulations for electronic records and signatures. Whether it is working with your own internal ERES Compliance and Assessment process or, through our own ERES and 21 CFR Part 11 Control Framework.

We can help you in the implementation project management and deliverables production including:

Computer System Validation Consultancy

Based on our knowledge of GAMP and Industry Best Practices for Computerised System Validation we provide risk-based validation services for small and large systems alike. We have experience in validating computer systems across the GxP spectrum from Laboratory Information Management systems, Manufacturing Materials Management and Dispensing Systems to Clinical Trial Management, Regulatory Document Management Submissions (CTD / eCTD) and Pharmacovigilance systems as well as infrastructure services including IT Service Desks, Data Centres and Networks.

We can help you in the implementation project management and deliverables production including: