The IQ 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. 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 IQ
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 IQ procurement stages.
Our Installation Validation (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 IQ 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 IQ to the Operational
Qualification (OQ) 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 IQ can be kept to the pre-powering up stage. Keeping the
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.
The scope of the IQ testing/inspections will cover the under listed subjects, but is not restricted to them alone.
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).
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
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.
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.
The User Requirements Specification template is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected for cGMP use that all essential support elements; i.e. maintenance, parts, operator & maintenance training, are planned and budgeted for. It uses three levels of User Requirements Specification Template (URS), URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final OQ and PQ functionality testing. A requirement mandated by cGMP regulations. It can be used on mechanical, electrical and software controlled, monitored or driven systems.
This definitive 1000 + page (including all attachments) Corporate Validation Manual arrives with you in USB memory stick format, this enables you at any time to download protocol or test-scrips documents and quickly edit them into company bespoke documents. In fact there are over $3,500.00 worth of superb documents, that form attachments to the DVM manual, which can be instantly copied. Once copied, the unique document interactive editing, allows you to produce high quality bespoke company documents; Such as the Validation Plan Template or the equally ubiquitous User requirements Specification template Design Qualification (DQ); in a few hours. The cost of the Definitive Validation Manual, will be recouped in the first few weeks of use. It will then go on to show a massive return on your original investment.