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



Validation Risk Assessment (Issue 11) $125.00

Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online 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 Risk Mitigation in Validation template.

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).



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 Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.

The Installation Qualification Template or IQ 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; The User Requirements Specification template 



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

The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (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 template. 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 current Good Manufacturing Practice use medical device use or a simple installation qualification template. 



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

You will find this validation online intuitive 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, along with the installation qualification template.




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

This validation online 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 online protocol template.