ERP Validation 

(Click picture to enlarge)

Enterprise Resource Planning (ERP)

You need an enterprise wide system to manage and coordinate all resources, information and functions of your business. But as a Life Science company, you need even more. You face regulatory requirements, patent expiration and other similar challenges specific to your industry. Wouldn’t it be nice to implement an ERP system that automates core business processes, collaborates with customers and suppliers, gives visibility into processes and finds the perfect balance between risk and compliance?

Cutting corners costs dearly

In order to meet this challenge, many companies are tempted to cut corners by ‘bolting on’ compliance validation at the end of the implementation process. Sometimes it even seems as though a URS has been written on the back of a napkin and user’s guides pass as functional specifications!

But this is a fatal flaw that will cost dearly in the end. It may very well be that such an ERP system functions satisfactorily with regards to finance, HR or legal departments. But when QA asks “Where’s the GMP support?” or “Where’s the quality control?” everything falls apart. We’ve actually witnessed projects that have gone 400 to 500% over budget due to shortcuts in the analysis phase.

Bridge the gap between IT and QA

What if you had the tools you need to navigate the minefield between QA and business functions? Would it help to get a structured framework that secures buy in from all stakeholders? A framework where stake holders together map out all documentation and validation requirements – both compliance and business related?

Save time and money

epista IT can help. We have long industry experience, deep understanding of compliance regulations and expertise with the relevant technology. Our structured approach invests the proper time in the analysis phase of your ERP implementation. The only way to formulate a real risk assessment is through dialog between QA functions and IT / business functions. The results are clear:

Increase your probability of success by creating mutual respect between business areas and common understanding of functionality and compliance issues.

Get cost effective validation because compliance is built into the process. The perfect balance between risk and compliance is our focus from Day One.

Your ERP system will be easy to validate and maintain due to the risk based approach of the validation.

We integrate requirements such as 21 CFR part 210, 21 CFR part 211 and 21 CFR part 820. And our approach is based on the GAMP guidelines.

epista IT can assist in several different ways:

• Independent advisor / interface to ERP vendor
• Subcontractor to vendor for validation tasks
• Simple validation support for ERP installation

A structured approach

Compliance becomes 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
• 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
• 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.