Installation Qualification Template

Edit this Installation Qualification Template into a Protocol


Installation Qualification Rationale.

The Installation Qualification Template execution; verifies that the equipment, and its ancillary systems or sub-systems have been installed in accordance with installation validation drawings and or specifications. It further details a list of all the cGMP requirements that are applicable to this particular installation qualification template. These requirements must all be satisfied before the IQ can be completed and the qualification process is allowed to progress to the execution of the Operational Qualification (OQ).

In the past equipment suppliers have often been delinquent in supplying the right scope and quality of support documentation for their products. As a consequence end user companies have not always had sufficient information (especially in the form of engineering drawings and specifications) about the equipment they have purchased, to develop and put into place the quality of documentation that regulatory requirements demand. For correct and trouble free qualification it is really essential that the scope and quality of the proposed equipment documentation; is specified at the equipment procurement stage.


Installation Qualification Template Introduction

Our Installation Qualification Template (IQ) protocol comes with an interactive SOP as an attached prefixed document. As you follow the installation validation protocol requirements as specified in the SOP, you complete the actual IQ protocol. This makes it a really easy and straight forward document to use. The Installation Qualification template is normally a stand alone document, however, with careful pre-planning, certain aspects of the IQ activities can be integrated with the Factory Acceptance Testing (FAT), and the equipment Commission Testing.

Conformance with current Good Manufacturing Procedures. (cGMP's) requires, that what ever approach is used, it is fully documented in the individual Validation (Master) Plan (VMP or VP). The IQ should not start with the Factory Acceptance Testing (FAT) or Commissioning tasks, but it should start before these tasks are completed; enabling the validation team to witness and document the final FAT and commissioning testing. The integration of these activities greatly reduces the costly and time consuming replication of unnecessary retesting.

There is a grey area of testing / inspection in the transition from the Installation Qualification Template (IQ) that is open to rationalization, i.e. it has to be done, but it can satisfactorily be included in either the IQ or OQ. On most projects the simpler the IQ is kept, the quicker it is completed, reviewed and out of the way, allowing progress to the OQ. It can therefore pay dividends to keep the IQ as basic as possible. Where possible, the Installation Qualification template can be kept to the pre-powering up stage. Keeping the IQ at this level allows healthy project progress. There should be no powering up or utility problems to hinder IQ sign off, and rapid progress through the OQ to the Performance Qualification (P1Q) and where applicable the Process Qualification (P2Q), becomes feasible. It can be reasoned that as soon as you power up, you enter the equipment operation stage, where verification of the User Requirements Specification (URS) and 21 CFR Part 11 verification testing are undertaken.

For this reason we have modulized the IQ and OQ, building in the tests and inspections that are not in this grey area, and building the one's that are, as modules that can be added to either the IQ or the OQ. This has not been done just because it might work, this has been advocated by us for some time. We have experience major delays to projects, caused purely by waiting for the client to complete document reviews and approvals. See Comment 9 in cGMP-FDA-483.


Installation Qualification Template Scope (IQ).

Review the leaders to the installation qualification testing and you will immediately recognize that almost all the testing is already insitu.

Learn how to edit the Installation Qualification template into a first class Installation Qualification Protocol. The Installation Qualification Template scope and intensity of this IQ will cover the under listed subjects, but is not restricted to them alone.

  • Verification that all components parts ~.
  • Verify installation is as specified ~.
  • Insert a brief description of what part of the validated product process ~~..
  • Insert a brief description of the operational function ~~. .
  • Verify supply voltages conform with ~~.
  • Verify that electrical installation qualification template complies with ~~.
  • Verify that all alarms and visual displays are ~~.
  • Verify that where used, the correct versions of ~~.
  • Confirm that the issue level of software ~~.
  • Identify and verify that serial numbers and model number of all ~~.
  • Review all calibration certificates for ~~.
  • Verify where used, there is signals continuity~~.
  • Verify in installation qualification template- signal continuity ~~.
  • Verify that the ambient conditions are ~~.
  • Verify that the documentation provided by the ~~ maintenance of the system ~~.

Documentation Relationships In Validation.

This graphic displays the relationships between validation documents.

INSTALLATION QUALIFICATION TEMPLATE 



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.



Installation Qualification
Template $115.00

The SOP used to generate this 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.  There is now no reason for not being able to produce 4 to 8, Installation protocol template per 8 hour day.</div>



Validation Master Plan (Issue 7) -- $115.00

The VMP must give an auditor an overall vision of how you: as a manufacturer, have  integrated cGMP into all of your regulatory controlled activities.  An organogram should indicate management structure and engineering drawings should indicate your  facility and utility systems along with product flow and personnel ingress and egress routing. This is a high level document and only practices and procedure should be  discussed but not detailed     This document interfaces with our Validation Risk Assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through from the installation qualification Template thro' the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.

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Validation Plan (Issue 8)  $89.00

This VP details and integrates all Installation Qualification template activities and procedures required for small to medium sized projects.  It must document activities and specify staff  responsibilities. It must set boundaries and define limitations.  It must define test methodologies and project times lines. It may be specific to one item or might cover several (similar or identical)  items.   It sets company and policy on all matters pertaining to the validation task.



User Requirements Specification (Issue 7.) $115.00

Each end user requirement must be listed in such a  concise manner that with the execution of a purpose designed test script a qualified observer could ascertain as to whether the documented acceptance criteria; for that requirement, has, or has not, been satisfied.   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 URS through to the final Installation Qualification template and on to the PQ and OQ functionality testing. This is a mandatory requirement for Full Life Cycle Validation (FLCV) of computer systems that are the subject of predicate rules. It can be used on mechanical, electrical and software controlled, monitored or managed systems.

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