The Validation Documentation Matrix, gives a very concise overall picture of your validation program. This four part matrix allows you to list all the equipment and systems that must be qualified. Each entry is allocated a row in the matrix. The row consists of eleven headings as shown below, these may be edited as required. In this matrix there is room to enter the document number, prefixed by, A to D. The document number gives you the instant cross reference to the current document and the A to D prefix, indicates the progress stage.
The basic philosophy underlying the use of a matrix for data verification and validation is to establish clear expectations and requirements that have been ground-tested for practicality and reasonableness this enables the organizations to succeed rather than fail for lack of direction.
An allied concern is that data verification will be viewed as an integral part of validation.
The incremental approach affords time for exercising leadership, changing organizational culture, refining processes, and establishing clear accountability. It avoids imposing a large front-end reporting burden that could meet with resistance and might end up significantly impacting other priorities.
All production process equipment must be listed in an multi-column matrix. Column 1, of this matrix designates the priority that the equipment is to receive in this validation task. Number one will be the first equipment qualified, and then the validation of the listed equipment will follow in chronologically order. Column 2, 3 and 4 are used to identify the item and its location. Columns 5 indicates whether the system generates data that is the subject of a predicate rules requirement. Column 6 will be generated from the execution of the risk assessment against the equipment. Column 7, 8, 9, 10 and 11 are used to assess progress.
This correct execution of this procedure will define whether the equipment under assessment must be validated, what the scope of the validation should be and whether the "equipment produces data" that is classified as predicate data. It therefore enables column 5 and 6 of the matrix to be completed, thus defining the scope and depth of validation that this piece of equipment demands.
During a regulatory visit the inspectors do expect to see a complete
suite of validation documents in place for each validation task. The
use and scope of the individual documents has been documented, discussed
and explained in detail. It is therefore obviously best policy to have
in place exactly what the regulator is looking for. The use of a
document packages ensures a multitude of regulatory requirements are
catered for and possibly a similar multitude of pitfalls, blunders and
omissions are anticipated and negated
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.
This Matrix must sit along-side your VMP
or PVP and together with these documents give a very concise overall
picture of your validation program. This four part matrix allows you to
list all the equipment and systems that must be qualified. Each entry is
allocated a row in the matrix. The row consists of eleven headings,
these may be edited as required (but come with all the standard
documentation titles inserted). In this matrix there is room to enter
the document number, prefixed by, A to D. The document number gives you
the instant cross reference to all the associated documents; the A to D
prefix shows the progress stage.