Validation in SAP projects
by Anand Krishna Sharma
Validation and adherence to regulatory guidelines is an integral part of any Life Sciences Company. One of the most popular IT systems in the market that form core of the functional system is SAP. SAP offers unique advantages, challenges and issues in catering to regulatory compliance due its inherent complexity, structure and processes. I would like to give a snapshot of such nuances in implementing Validation and compliance checks at a very high level in SAP environment.
SAP validation projects / programs fall into the following broad categories:
- Fresh validation of implementations from scratch, including business concept implementation at the transformational level.
- Revalidation - many factors contribute to this like major structural or policy change in the organization, mergers of companies, acquisition etc bringing in such changes.
- Internal time phased reviews and validation support, all along the ERP life cycle.
- Retrospective or post-facto validation, usually in view of multiple parallel changes in the system or regulatory impacts due to compliance related issues.
SAP has some unique challenges because of the volume, complexity and interdependencies among various modules in SAP. Some of the common issues are pose challenges even in some of the best implemented / documented systems are as follows:
- Lack of complete Lifecycle documentation
- Lack of comprehensive inventory of the company's computer system components and landscape
- Lack of definition of outcomes and results expected of the system
- Expected specification of software details like versions, upgrades, wrappers, etc
- Incompatible softwares that do not meet SAP specifications
- Opaque black-box packages, whose source code is not made available for validation
There are different classes of Validation documentation created for a computer system:
- Lifecycle documents are those that live till the system exists.
- Project documents - Validation documents that are created to facilitate execution of project.
- Validation reference documents - Those that are taken as learnings from the previous projects executed. These will form best practices and guidance documents.
I will highlight some key aspects of Validation in SAP in my next blog post.
About the Author
Anand is a Client Solution Manager with the Insurance Healthcare & Life Sciences (IHL) unit. He handles and anchors opportunities related to the Life Sciences domain, and has managed various large projects in the past. He has extensive experience with regards to regulatory compliance and validation and is an IBM certified e-Business solution Designer. Anand will blog on trends in life sciences, regulatory compliance, validation and related topics.
