ERP/SAP Validation

Lean ERP/SAP ® Validation: Is slim and cost effective feasible?

"Validation drives costs! ... you cannot validate SAP®!" This type of prejudice has survived in the minds of operators and users of ERP systems, even after more than 10 years of validation. Previous validation procedures were in fact not always lean and cost-effective, but may have actually produced quite significant additional effort in the quality and other involved departments. Furthermore, ERP/SAP® consultants commonly have a rather limited understanding of the needs of the regulated industries. In the past, many processes were carried out twice or single-handedly by the validation team. Furthermore, IT managers commonly expect controllable change management to be rather costly.

"Validation brings additional complexity to the projects!"
This thesis has also been around for years. The rules provided by the regulatory authorities and the GAMP5® industry standard are forcing companies to produce written proof in respect of the safety, accuracy, and authenticity of the programmes, algorithms and data. This is to ensure the quality and safety of the drug or medical device. One option is mapping this process to the Software Development Life Cycle (SDLC) and the associated procedures, test processes and documentation steps. With GAMP5, users are no longer forced to stringently follow the phases of the rigid V-model for the entire project. The project is permitted to evolve through controlled changes, or another SDLC method may be applied.

Minimise efforts and meet milestones!
Validating an ERP/SAP system, and running it in a valid state without exceeding cost and time limits requires compliance with certain methodological constraints. Following the implementation of the SOPs required for procedures and documentation, the cGxP-critical processes affected by the ERP/SAP® system are identified and subjected to risk analysis. Planning of risk management limits the efforts to the essentials. If the validation activities are synchronised with the implementation or migration project in a sensible manner, many documentation and test steps can be performed more efficiently. This is a sustainable solution for meeting project milestones during the introduction of the system. The GAMP5® Guide published by the ISPE in 2008 quite rightly points out that validation ought to be strictly based on the risk-oriented approach. Once again this constitutes a consideration of costs. Tools such as the SAP Solution Manager are a welcome aid for the implementation, testing and documentation in an inspection-proof manner - if used correctly.

Classic quality management previously demonstrated that a controlled implementation and modification process yields savings. The early introduction of change management and system operation SOPs for ongoing operations is thus a factor in reducing the "cost of ownership", as well as contributing to the stability of the system.

"Lean ERP/SAP® Validation" with expert support
Take advantage of the profound experience of the Chemgineering Business Designers in facilitating the validation of ERP, and especially SAP® systems. In the scope of the validation of computerised systems, including ERP environments, our consultants have always placed great emphasis on cGxP-relevant functions and risks, and are putting the methodological ideas of GAMP5 into practice. We will support you in implementing valid operations of your ERP/SAP® system with the best possible cost-benefit ratio.

 

Click here to see the refernce projects "Computerised System Validation - ERP/SAP Validation" 

 

For further information please contact Dr. Thomas Karlewski

Chemgineering Business Design AG | Binningerstrasse 2 | 4142 Münchenstein | T +41 61 467 89 00 | F +41 61 467 89 01 | www.chemgineering.com | info@chemgineering.com