Validation Templates design is of critical importance when regulatory compliance and clarity of purpose are prerequisites. In these circumstances it is only the bold and confident that will actually strike out using innovative and intuitive thinking to produce templates that can actually save in time and cost.
It is the desire to reduce costs that has led to the introduction of our 4Q template design, where It is left to the 4Q protocol to apply all the verification tests and inspections.
So what does the VrrP actually achieve. It leads (with built in prompts) a competent person through the process of defining; the validation task boundaries, identifying and allocating all responsibilities, protocol contents and methodologies, application of risk mitigation, Structure of test scripts, Sequencing of test scripts execution.
This new 4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the these four protocols and carefully weaving them into one notably easy to use protocol, we have made significant progress in reducing validation paperwork. Reductions of up to 75% have been quoted as the likely total. Integrating the old style DQ/IQ/OQ/PQ protocols into one 4Q document will be an enormous savings in man hours in the authoring, reviewing, updating and approving tasks. With the simultaneous introduction of the new Validation risk & Requirements Plan (VrrP) which integrates the VP, VRA & URS into one document - equipment validation has been reduced to two document.
The User Requirements Specification (URS) is raised by the end user at URS Level One stage, and specifies what the end user requires the equipment to do. Additionally, any regulatory guidance, mandatory instructions or conditions of use, must be included into the URS. The URS must be the subject of one or more peer reviews where the user, the maintainer and QA, review and ensure that the document is clear and concise in all the requirements detailed.
Design Qualification is used at the stage where a design that has been developed from the, VMP / URS /GAMP 5 / cGMP / and other Health and Safety Guidelines, is reviewed and commented on by competent persons to ensure that the designed equipment, if built, will satisfy all the detailed specified requirements. It can also be used to review an of the shelf item to ensure it will satisfy the URS.
The Installation Qualification (IQ) must verify that the equipment has been installed, activated or put into use in accordance with the manufacturer’s requirements, cGMP rules and regulations, and all applicable health and safety requirements. The IQ should further include a review of maintenance procedures, repair parts lists, and calibration methods
The execution of the Operational Qualification (OQ) protocol verifies that the functionality of the equipment conforms with functionality specified in the Functional Specification (FS) for the system. This verification is achieved by subjecting the equipment to a range of fully documented inspections and tests.
It is imperative that all tests and inspections detailed in the validation template for VMP and other protocols are clearly and concisely detailed. Each test and or inspection must be referenced to its effect on the product or the regulation that mandates it. Validation scopes, boundaries and responsibilities must be set out in the Validation Plan (VP). Protocol authors should never be allowed to commence construction of validation template protocols without being made aware of the company constraints, definitions, scopes, and methodology and individual responsibilities as authorized by company policy documentation or the Validation Plan. For concise cost effective document production the authors must be trained in writing protocols in accordance with these comments and incorporating all of the details listed below.
Over-all protocol standards are shown in the SOP’s for the different protocols and are incorporated into template for VMP along with all our other templates. Here we are concerned about the testing element alone. All testing must be detailed and pre-approved by a qualified person to ensure the system under test has been adequately tested. Each test must comprise of;
A Rationale ; giving the reason and or object of the test.
A Test Method ; giving details of the desired test methodology.
An Acceptance Criteria ; giving details of the anticipated acceptable results of the tests.
A Test Result ; giving details of the actual results obtained that satisfied the acceptance criteria.
The test result must be initialled (or signed) by the person executing the tests, on completion or at each significant stage.
Each test must be designed to verify an element of the equipment functionality.
Each test must a have a result that is clear, unambiguous and known.
The test method must call up for the recording of the test result parameters. (No ticks or tick boxes, no generalities).
Each test must be witnessed or the results must be reviewed by a competent person.
The overall test results must be approved by a competent person.
For Your Security We are Now TLS 1.2 Compliant
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained
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. Resulting in the document becoming notably easier to use and quicker to review and amend. 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.
4Q Equipment Validation4u 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
validation4u 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 and compliant with FDA GMP Part 11 legislation.
This quite unique two
document package is all that is required to fully validate; to cGMP standards,
equipment used in a regulated facility. A lot of effort has gone into ensuring
that repetitive instructions and actions have been designed out and innovative
and intuitive risk-based methodologies have been incorporated.
Both documents are prefaced with a methods' Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique but also highly cost-effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics and are compliant with FDA GMP Part 11 regulations.