(312) 207-5800 REQUEST INFORMATION WHAT WE DO OUR COMPANY RESOURCES CONTACT US Regulatory Compliance Products Off-the-shelf commercial software solutions are critical for pharmaceutical, medical device, and biotechnology companies. Arbour Group offers you specific regulatory products that will ensure compliance. Home Products The use of applications software is governed by U.S. and international guidelines and regulations. To ensure regulatory compliance and reduce business risk, commercial business applications need to be stringently validated. Failure to comply can lead to regulatory roadblocks and a costly loss of business. The anticipated benefits derived from commercial solutions cannot be realized until those solutions are fully validated. Regulatory Validation Product Availability SAP S/4HANA SAP Business One SAP Business ByDesign Oracle E-Business Suite Oracle ERP Cloud JD Edwards QAD MS Dynamics ProcessForce NetSuite Validation Infor ERP Validation What Our Validation Product Packages Give You Validation Plan This template is used to create a comprehensive validation plan to guide your validation efforts. The template can be easily customized to accommodate your unique validation situation. User Requirements Model This includes standard business requirements that are tailored to create a baseline user requirements document. The model identifies the needs that must be met by the client's software solution and the underlying business functions that require validation. Traceability Matrix This visually links the business requirements to be validated with the corresponding test scripts that will be used to test those requirements. Installation Qualification Includes scripts that validate that the hardware and software components were installed within the design intentions and guidelines established by the supplier and the client. Operational Qualification Includes scripts that validate that the system components perform the intended functions and consistently operate within established limits and tolerances. Performance Qualification This template is configured to the client's unique environment and enables validation that the system components function as a complete system and maintain acceptable levels of operating performance in the intended production environment. Our Validation Benefits Shorter Timeframes Our time-tested, field-proven validation products certify commercial business solutions in an optimally expedient and secure manner. This means that clients are able to put solutions to work more quickly and realize benefits more quickly. FDA 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 FDA approval of new product introductions and brand acceptance in the marketplace. Whether it's a just purchased solution or an upgrade to an existing application, Arbour Group's validation products help manage business risk by putting that solution to work quickly and reliably. Request More Information This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. WHAT OUR CLIENTS THINK 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. Vice President, IT at a Fortune 500 company Products SAP S/4HANA SAP Business One SAP Business ByDesign Oracle E-Business Suite Oracle ERP Cloud JD Edwards QAD MS Dynamics ProcessForce NetSuite Validation Infor ERP Validation Services Audits Validation & Compliance Research Managed Services Testing & Certification Quality Assurance Regulatory Education & Training Digital Compliance Services Digital Transformation Services Testing & Certification Application Software Testing Embedded Software Testing Enterprise Software Testing Software Certification Industry Pharmaceuticals Medical Devices Biotechnology Diagnostics Arbour Group Warranted regulatory solutions, your partner in compliance. Request Information (312) 207-5800 One Parkview Plaza, Suite 660 Oakbrook Terrace, IL 60181 All Rights Reserved ©2021 Arbour Group LLC. | Sitemap × We use cookies to help us offer you the best online experience. By continuing to use our website or closing this window, you're providing consent regarding cookies. If you want to learn more read our Privacy Policy.