Validation Products
Off-the-shelf commercial software solutions are important elements of manufacturing, quality and clinical systems for most companies in the pharmaceutical, medical device and biotechnology industries. These applications are governed by U.S. regulations (e.g., GMP, GLP and CFR Part 11) and other requirements and guidelines (e.g., GAMP, MHRA and TGA). 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. Further, the anticipated benefits derived from commercial solutions cannot be realized until those solutions are fully validated. It follows that the expected return on investment is dependent on the validation process.
Validation Product Package
Arbour Group’s validation product package includes:
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 need to be validated.
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.
OPERATION 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.
Validation Benefits
The primary benefits of our validation products are twofold:
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.
Product Availability
Arbour Group has products to validate the following leading commercial software solutions:
- Oracle
- SAP
- BPCS
- QAD MFG/PRO
- PeopleSoft
- J.D. Edwards
- PRMS
- AMAPS
- Baan
- Prism
- Documentum
- TrackWise
- ARISg
- Datastream
For additional validation product information or to arrange for a demonstration, click on the “Contact Us” tab at the top of this page or call 312.207.5800.
