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ERP Validation – epista IT’s well proven methodology

A structured approach
Compliance and validation become an integral part of the implementation project with the following activities:

Initial QA Workshops
We start by bridging the gap between IT and QA. Using our experience from many other similar projects, we get buy in from all stakeholders regarding business requirements and validation criteria.

By addressing the following parameters, the workshop will result in a formal validation plan:

• Define and match the project’s compliance level with the company’s current compliance level;
• Define GxP handling, including a risk assessment of functional requirements (types);
• Define all validation activities for by the project; and
• Define and assign compliance roles.

epista IT’s consultant can provide the following guidance:

• Evaluate whether requirements are GxP critical;
• Risk asses the requirements (GAMP classification / software category / detectability);
• Add requirement and risk assessment to URS; and
• Add functional requirements to functional spec / functional requirements spec

ERP implementation
epista IT will assign a validation representative to the development team during implementation. This person will be responsible for all GAMP related activities including document and source code review and other integrated GAMP elements. They will also ensure that good test practices are executed during unit testing.

Validation
Using the Validation Plan, URS, Functional Specification and Traceability Matrix, qualification material is developed.

Installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) scripts are developed based on GAMP best practices and the relevant ERP platform.