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.
The use of applications software is governed by U.S. and international guidelines and regulations, such as FDA 21 CFR Part 11 and EU Annex 11. 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.
Demonstrate regulatory compliance to the FDA and other international agencies with Arbour Group’s validation products and services.
Regulatory Validation Product Availability
What Our Validation Product Packages Give You
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.
WHAT OUR CLIENTS THINK