USER REQUIREMENTS SPECIFICATION. (URS)

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Without doubt the User Requirements Specification (URS) , is the most critical of documents and yet the most often botched document. Be the system purely mechanical or a mix of electro-mechanical or solely a software program, the successful compilation and execution of the Operational Qualification(OQ) (for functionality) and the Performance / Product Qualification(PQ) (for operability), hinges on the detailed system expectations, given in the URS, being correctly detailed and specified. For successful validation there must be traceability from the URS Level-1 (end user requirements) to URS Level-2 (functionality that will deliver URS Level-1) to URS Level-3 (Software Code required to deliver URS Level-2), achieving this is the fundamental building block for successful full life cycle function testing.
Bringing these needs and tasks together in a manner which will verify design fitness for purpose, has traditionally been a tedious and laborious labour. It involved trawling the VP and URS and cross-referencing to the Functional Specification and the Design Specification and the associated Test Specifications, sometimes, with only limited success. The design of our document is unique, it requires the URS to be an active document up to completion of the Design Qualification (DQ). The DQ will be executed against the three level URS, and verify that the code (if there is any) specified in URS Level-3, will deliver the functionality detailed in URS Level-2, which in turn will deliver the operability that the end user specified in URS Level-1.
This document consists of a generic template which uses an attached SOP to allow you to quickly auto-populate the template. It then takes you page by page through the template allowing to develop the template into your own bespoke company URS. It makes it simple and quick to produce a quality URS.

FDA and Quality��..The FDA has raised the bar��. The rationale for change, the approach it has taken and the progress achieved are not as good as some think��... In September 2003, The Wall Street Journal published an article informing all that pharmaceutical �manufacturing techniques lag behind those of potato-chip and laundry-soap makers.���. The same article correlated the rise in recalls with quality problems and noted that despite fines in excess of US$500 million for manufacturing failures��acceptable levels of quality were not, and are not, being achieved.

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URS JUSTIFICATION.

The User Requirements Specification (URS) must be comprehensive. Each and every requirement relating to product safety, identity, strength, purity, and quality must be identified. Hence, Quality Assurance (QA) must have a significant role in reviewing and approving the final set of requirements, and must be an approver of changes to any requirement that can affect the above product or process attributes (e.g., cGMP�s).

Given a comprehensive User Requirements Specification that has been approved by QA and is under project change management, the Design Qualification (DQ) process then can be reduced to two key objectives:

Documented verification that the overall design appears to address, by some means, each and every requirement affecting the product and performance of the manufacturing process (or, in the case of unknown product or multi-product manufacturing facility, the required equipment/ system performance capabilities).
Identification (and documentation) of the critical individual physical components, attributes, and operational features that directly support meeting each requirement.

If end user requirements are clearly identified with sufficient detail, then IQ, OQ, and PQ protocols can be streamlined and focused, yielding a more effective and efficient qualification process. Remember always that, DQ cannot be performed without first formally defining requirements. Meeting requirements is the ultimate objective of the project; verifying requirements have been met is the role of VALIDATION.

URS SCOPE.

User Requirements Specification (URS) Scope includes but is not limited to;

The scope of the URS must include but is not limited to:
Level-1, full details of end user operability.
Level-2, full details of functionality.
Level-3, software functionality interface.
A full description of the required system performance.
Performance criteria, critical parameters and operating range.
Cleaning and maintenance requirements.
Appropriate regulatory requirements.
Documentation requirements.
Training requirements.
All none industry standard testing that may be required.

URS AND THE SOFTWARE LIFE CYCLE.

URS IN THE QUALIFICATION PROCESS.

USER REQUIREMENTS SPECIFICATION.