USER REQUIREMENTS SPECIFICATION. (URS)
Definition: User Requirements Specification (URS).
To create a GMP compliant URS, the requirements of the end-user
must be set out as a sequence of events. Each event must be clearly defined, testable
and include a pre-approved acceptance criteria. (This gives you Level 1 of your URS).
User Requirements Specification Scope.
Learn how to prepare a User Requirements Specification (URS) that will streamline your whole validation task. No matter whether the system is purely
mechanical, or a mix of electro-mechanical, or solely a software program, the
successful compilation and execution of the Installation
Qualification (IQ) (for installation), Operational
Qualification (OQ) (for functionality) and the Performance / Product Qualification
(PQ) (for operability), is dependent on an URS containing clear, concise and testable requirements.
Once the end-user requirement specification or URS as it is commonly called; is documented, agreed and approved they form the basic URS Level-1 document. The engineers (or vendor) can then commence the preliminary design to establish exactly what functions are required for each of the items specified in the user requirements specification, the end user has listed. Once this functionality is documented and approved it forms the URS Level-2 document. This is the final level of the URS unless software is used.
If software is to be used, the URS Level-2 document, is passed to the code writers. As the code is written, lines, or groups of lines, of code must be attributed to the individual functions that necessitate their presence. The completion of this task results in the completion of the document.
Developing the URS to this level is unique in most industries, but is, standard practice in strictly regulated industries, as it is a major building block in the creation of quality software. The URS Level-3 document, contains all the traceability which is deemed mandatory for software assessed to be critical to product quality, in the pharmaceutical regulated industries.
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 you to develop the template into your own bespoke company URS. Just ask about validation time that is saved using this simple and quick to produce a quality URS.
User Requirements Specification (URS) Defined.
The URS is originated by the end user extrapolating requirements directly from the production processes. These high end user requirements are then passed to engineering who are tasked with turning them into a complete procurement package. A package that will include all aspects of purchasing, installing and operating the specified system. Further to these direct requirements there are also a multitude of indirect requirements, such as; documentation, manpower, training and test equipment that must be fully researched, investigated and specified. The URS must be written in a format that allows each of these requirement to be verified as being “fully satisfied” or not.
User Requirements Specification Justification (URS)
They 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 list 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; in the URS, 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.
User Requirements Specification Scope.
User Requirements Specification (URS) Scope includes 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.
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SOP Equipment Validation.
The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
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Validation Risk Assessment (Issue11.) -- $125.00
The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
Equipment combined IQ/OQ/PQ Protocol. $159.00
This combination protocol has been produced in response to several
hundred reader suggestions we received in our ‘Suggestions Section’. It
has been carefully designed to make it the preferred choice for Process
and Laboratory stand alone equipment. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The
IQ section establishes documented verification that key aspects of the
equipment adhere to approved design intentions and that the
recommendations of the manufacturer have been suitably considered. The
OQ section establishes that there is documented verification that the
installed system functions as specified and that there is sufficient
documentary evidence to demonstrate this. The PQ section gives
documented verification that the equipment performance in its normal
operating environment is consistently exactly as specified in the URS.
12000002_VrrP_Equipment_iss-4. -- $298.00
This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation costs without infringing regulatory standards.
12000006_4Q_Equip_iss-4. -- $298.00
4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word.