Services > IT Compliance

With epista IT, you will get expert compliance support all the way through your IT system’s life cycle

General compliance consulting
epista IT has more than 100 man-years of experience in formulating compliance strategies for a wide range of IT systems, assisting both large and small organizations. This experience enables us to scale compliance strategies to suit any business – defining the perfect balance between risk, cost and compliance.

IT system implementation and validation
Our structured GAMP based project methodology invests the proper time in the analysis phase of your system implementation. The only way to formulate a validation strategy is through real risk assessment dialogue between QA functions and IT / business functions – facilitating a common understanding of regulatory requirements and the technical architecture of the system.

epista IT is focused on validation of a large variety of systems with a specialty in the validation of:

• ERP (Enterprise Resource Planning)
• QMS (Quality Management system)
• EDMS (Electronic Document Management system)
• CTP (Clinical Trials Portal)
• eCTD (Electronic submission tools)
• SharePoint infrastructure

We integrate requirements from 21 CFR part 210, 21 CFR part 211 and 21 CFR part 820 into the solution and validate according to the GAMP guidelines.

Is your IT department ready for inspection?
With the FDA’s release of 21 CFR Part 11 and the EMEA’s release of Annex 11, inspectors have invited themselves into the IT departments. As a consequence, a sound quality management system needs to be established to cover the processes. We will provide you with the necessary policies and procedures that support your daily IT operations. We can also perform “unofficial” quality audits in order to prepare your IT organization for inspections and customer audits.