VALIDATION TEMPLATES



Since this is the era of "Risk Based" software validation - it is of the utmost importance to ensure that the validation scope is risk derived. Consequently a purposed designed Validation Risk Assessment (VRA)  is absolutely essential if flawless validation is to be achieved.


Validation Templates Innovation.

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.    

4QTM Equipment Validation Protocol.

This new dynamic 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.

Template for URS

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. 

Template for DQ

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.

Template for IQ

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

Template for OQ

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.


Validation Templates Documentation Interface.

Graphic for  Validation Templates for documentation.

Authoring Quality Protocols.

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 justified by quoting the requirement 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, methodology and individual responsibilities as authorized by the company practice and procedure policies  as promulgated by the company.  For precise effective validation all protocol tests and inspections must be cross-referenced to the requirements detailed in the User Requirements specification, which mandates their inclusion.

Over-all protocol standards are detailed 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 must be justified and verified as fit for purpose comprise of;

Main Sub-headings in Test Scripts.

Rationale; giving the reason and or object of the test.

Test Method; giving details of the desired test methodology.

Acceptance Criteria; giving details of the anticipated acceptable results of the tests.

Test Result; giving details of the actual results obtained that satisfied the acceptance criteria.

General details that must be adhered to.

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.


VALIDATION TEMPLATES



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation 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 and associated standard operating procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation IQ, takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification Protocol. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.




Combined IQ/OQ/PQ for Spreadsheets. (issue-2) $159.00

This combination protocol has been specifically designed to verify that all aspects of your spreadsheet conform to best practice and that the spreadsheet layout ensures consistent and accurate use and results. The tests and inspections normally authored in separate protocols have been assembled in one protocol which is divided into three sections. This protocol enables you to verify that your developed spreadsheet application is GMP compliant, thus avoiding 483s and warning letters. You can now validate your application with minimal documentation. Equipment Validation Protocol, validation protocol template.



Design Qualification (Issue 5) -- $115.00

The Standard Operating Procedure attached to this generic design Performance qualification Template, 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



VrrP_Equipment
Issue - 4. 

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. 


12000006_4Q_Equip
Issue - 4. 

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 & Performance qualification template P1Q) 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.



Combined IQ-OQ-PQ Equipment. (Issue-8)  $159.00

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.