The leading commercial business software for emerging small companies provides complete business management for financials, sales, customers, inventory, suppliers and purchasing. SAP Business One now has a pre-packaged validation solution for the life sciences industries. If you are newly implementing or planning an upgrade, validation is now available as a fixed-price, pre-written packaged solution.
The Arbour Advantage
Licensed, deployed and supported by an SAP partner, the pre-packaged validation solution is based on Arbour Group’s extensive industry knowledge and expertise accumulated years of experience with leading pharmaceutical, medical device and biotechnology companies. Arbour Group’s SAP Business One compliance product allows you to meet your obligations to both domestic and international authorities (e.g. FDA, HPRA, MHRA, EMA and TGA) in a timely and cost effective manner.
SAP Business One 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:
- Business Requirements model
- Validation Plan template
- Traceability Matrix
- Installation Qualification test scripts
- Operation Qualification test scripts
- Performance Qualification template
- Validation Summary Report template
Full Maintenance Program
Licensed Product Support is a maintenance program that assures validation documentation integrity for Arbour Group enterprise software compliance packages and deliverables. Updated documentation is provided in conjunction with regulatory compliance expertise that ensures an ongoing compliant environment. Collectively, our pre-packaged validation product, maintenance program and industry professionals combine to form a comprehensive SAP Business One compliance solution.
The Arbour Assurance
Our SAP Business One validation product guarantees you the maximum protection in your investment by providing the following primary benefits:
Shorter Timeframes: Our time-tested, field proven pre-packaged validation product certifies compliance 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.
Whether you are installing SAP Business One for the first time, converting from a legacy system or implementing a release, Arbour Group’s pre-packaged validation product will help you manage your business risk quickly and reliably.
SAP Business One Software
SAP Business One (SAP B1) provides a comprehensive ERP solution for budding companies in the Life Sciences Industry. SAP B1 software can be integrated with a manufacturing program of choice alongside financials, operations and customer relationships capabilities. SAP Business One can also be deployed on the S/4HANA platform. Streamline key processes as your company evolves in its industry. SAP commits to periodic external reviews and audits for their customers to meet their own compliance standards. They follow one common data security outline that includes international security and privacy regulations. The latest version of SAP B1 (SAP Business One 9.3) includes enhancements to production, project management, RMA features, and usability.
Ensuring Compliance for SAP Business One (SAP B1)
SAP is not responsible ensuring that global regulatory requirements in the Life Sciences are met. The responsibility to implement and test an updated software is the responsibility of the company operating the software. If your SAP Business One system is not validated to meet set standards, a company may be flagged or even shut down by an applicable agency. Arbour Group’s SAP Business One validation product and consulting expertise provides the necessary solution for your software compliance needs. Arbour Group’s Maintenance Program will keep validation documentation up to date with product releases, demonstrating to regulatory agencies that your SAP software is not only following privacy regulations, but Life Science requirements as well.
Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner.
The use of Arbour’s validation product greatly facilitated the process.
The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers.
Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
Arbour Group provided effective validation services to us and were a valuable part of the overall success of our company-wide ERP implementation.
Their integration into our multi-phase ERP roll out was seamless and assured us of comprehensive regulatory compliance.