The leading commercial business software now has a pre-packaged validation solution for the life sciences industries. If you are newly implementing or planning an upgrade to SAP, validation is now available as a fixed-price, pre-written packaged solution.
The Arbour Advantage
Sold, deployed, and supported by an SAP partner, the pre-packaged validation solution is based on Arbour Group’s extensive industry knowledge and expertise accumulated from years of experience with leading pharmaceutical, medical device, and biotechnology companies. Arbour Group’s SAP compliance product allows you to meet your obligations to both domestic and international authorities (e.g. BfArM, FDA, IMB, MHRA, and TGA) in a timely and cost effective manner.
Compliance Offering
As an alternative to manual, labor-intensive validation efforts, Arbour Group’s ready off-the-shelf validation package incorporates industry compliance best practices to include:
- Regulatory Process Map and Business Requirements model
- Validation Plan template
- Traceability Matrix
- Installation Qualification (IQ) test scripts
- Operation Qualification (OQ) test scripts
- Performance Qualification (PQ) template
- SOX Qualification test scripts
- Validation Summary Report template
Full Maintenance Program
Arbour Group provides updates when patches and support packages are delivered by SAP as well as when regulations change. As we are a global organization with offices and professional staff throughout the US, EMEA, and Asia, Arbour Group is able to support you continuously to help your company achieve and maintain regulatory compliance of your software systems. Collectively, our pre-packaged validation product, maintenance program and industry professionals combine to form the SAP compliance solution you are looking for.
This SAP validation product guarantees you the maximum investment protection in your investment in SAP by providing the following primary benefits:
Shorter Timeframes: Our time-tested, field proven pre-packaged validation product certifies compliance of the SAP in an optimally expedient and secure manner. This means you are able to 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.
Complementary Service Offerings
Arbour Group supplements the validation product solution with a full complement of Governance, Risk and Compliance Management (GRC) service, product and education offerings. This expands the coverage to other agencies including: DHS, DOD, EPA, OSHA, and SEC. These GRC offerings form the platform for defining, maintaining, and monitoring risk throughout the life cycle of SAP by establishing a secure framework for conducting compliant business processes, now and into the future. Our clients achieve:
- Sustainable compliance
- Decreased risk and cost
- Improved business performance
We promote a unified, holistic approach to SAP compliance and risk mitigation across the global enterprise. This approach is embodied in our offerings in the areas of:
- Change control and change management
- Version upgrade revalidation
- Automated testing tool deployment
- Unit and integration testing
- Service desk incident and problem management
- Change management administration
Whether you are installing SAP for the first time, converting from a legacy system, or applying a patch, Arbour Group’s pre-packaged validation product will help you manage your business risk quickly and reliably.
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