The life sciences industry deploys enterprise software as a critical part of a strategy to manage supply chain functions, achieve operational efficiency and manage data. Since life sciences companies must adhere to Food and Drug Administration (FDA) regulations and guidelines, software solutions must comply with the requirements of FDA 21 CFR Part 11, Electronic Records; Electronic Signatures as well as other guidance based on segment, i.e., pharmaceutical, biopharmaceutical, medical device, diagnostics, etc.
SAP is the leading provider of end-to-end supply chain software for life sciences to include offerings for startups, mid-market organizations and global enterprises that can be tailored to ensure an appropriate business fit.
- SAP S/4HANA Private Cloud – a robust solution for large-scale enterprises, focused on flexibility and complex process requirements
- SAP S/4HANA Public Cloud – a comprehensive solution for large scale and mid-sized companies whose process complexity is moderate
- SAP Business ByDesign – scalable, integrated capabilities for mid-sized companies looking for growth and efficiency
- SAP Business One – a cost-effective approach for small companies covering essential business functions
Arbour Group has a pre-packaged validation solution for each SAP software product. Our extensive industry knowledge and expertise is the result of 25+ years of experience with life sciences compliance. Arbour Group’s SAP compliance products provide assurance that the obligations to both domestic and international authorities (e.g., BfArM, EMA, FDA, HPRA, MHRA, and TGA) are met in a timely and cost-effective manner.
Compliance Offering
Arbour Group pre-packaged validation compliance products incorporate industry best compliance best practices to include:
- Validation Plan template
- Business Requirements Specifications
- Traceability Matrix
- Installation Qualification test scripts
- Operational Qualification test scripts
- Performance Qualification template
- Validation Summary Report template
The Arbour Assurance
Our SAP validation compliance packages simplify and streamline the validation process resulting in:
Shorter Timeframes: Our time-tested, field proven pre-packaged validation product certifies compliance in an optimally expedient and secure manner. This means you can accelerate the time-to-value of your commercial business software investment.
Regulatory Agency Approval: Properly validated solutions are more likely to avoid regulatory scrutiny in the form of citations and audits. These time-consuming and disruptive events can pose a real business risk as it relates to Agency approval of new product introductions and brand acceptance in the marketplace.
Whether you are installing SAP for the first time, deploying a new SAP version or converting from a legacy system Arbour Group’s pre-packaged validation product will help you manage your business risk quickly and reliably.
Contact us today to learn more about Arbour Group's SAP Validation Packages.
SAP Validation Packages Offered: