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 Microsoft Dynamics, validation is now available as a fixed-price, pre-written packaged solution.
The Arbour Advantage
Licensed, deployed and supported by a Microsoft Dynamics partner, the pre-packaged validation solution is based on Arbour Group’s extensive industry knowledge and expertise accumulated from years of experience with pharmaceutical, medical device and biotechnology companies. Arbour Group’s Microsoft Dynamics compliance product allows you to meet your obligations to both domestic and international authorities (e.g. BfArM, FDA, HPRA, MHRA, and TGA) in a timely and cost effective manner.
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. An Annual Regulatory Assessment and other benefits are included. Collectively, our pre-packaged validation product, maintenance program and industry professionals combine to form a comprehensive Microsoft Dynamics compliance solution.
Dynamics 365 for Finance and Operations (AX)
Predominately used by medium-large sized manufacturing organizations, MS Dynamics 365 for Finance and Operations (formerly AX) is an automated ERP with a proactive supply chain to meet customer needs. Whether on-premise, in the Cloud or as a hybrid model, this centralized global financial management solution has advanced capabilities for process automation, accounting, budget planning, budget control and three-way matching.
Dynamics 365 for Finance Operations with no code-configuration services allow users to adapt to evolving legal requirements that affect regulatory reports, e-invoices, payment formats and tax rules. However, the ERP system does not have an automated process to validate its software to regulatory standards. Arbour Group’s pre-written validation solution assists in meeting compliance guidelines set in the Life Sciences. With the global capabilities 365 for Finance and Operations possesses, Arbour Group can meet necessary global regulatory requirements.
Dynamics 365 Business Central (NAV)
The software choice for small-medium sized enterprises mostly in the wholesale industry, MS Dynamics 365 Business Central (formerly NAV) possesses capabilities across CRM and project management, finance, operation and supply chain. Using the same code base as NAV2018, the up-to-date version increases the functionality in NAV with added new features, supplementary functionality and brand-new interface.
With the option to use on-premise or the opportunity to connect data to a pure Cloud SaaS model, Business Central can provide real-time chart financial performance by connecting data across accounting, stock, sales and customer interactions. Whether nationally or globally, Business Central connects users all over the world, making it essential to meet set international regulatory guidelines. Arbour Group’s packaged solutions meet compliance standards and assist life science clients throughout the world, supporting software validation needs and delivering warranted solutions.
Small-medium sized life science companies use Dynamics GP (formerly Great Plains) to enhance control over their financials, inventory and operations. Designed to work with Microsoft Office and the choice to upgrade in functionality, GP is a customizable option for the life sciences industry. GP also has the capability to integrate with Microsoft’s Power BI, a business intelligence platform that offers AI-powered direction to recommend next steps and areas of improvement.
Whether deploying in Azure or staying on-premise, Microsoft GP streamlines operations by visualizing the processes. However, the procedures in place must be certified to meet regulatory guidelines. From the FDA to the EMA, Arbour Group assists in meeting software validation standards put in place by international agencies. Our pre-packaged solutions coupled with our premier maintenance programs will assure compliance as well as industry best practices.
The Arbour Assurance
This Microsoft Dynamics validation product assures you the maximum investment 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 Microsoft Dynamics 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.
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.