The GMP Vendor Audit (VA) requirement sprung to life in the aircraft industry, in the late 1950’s, when it became very apparent that you could not just build an aircraft, and then certify it fit-to-fly; just by inspecting it. Quality had to be built into every manufactured part and every construction process. Opinions were out and documented company approved practices and procedures were in. Quality Management was born, not an event - a process - a mindset and a step change. Years later the same problem became apparent to the medical regulators, and cGMP appeared. The inspection and assessment of quality became extremely important, and assessing your suppliers became mandatory. Documents such as IQ,- OQ, - DQ, - PQ,- VRA,- VP, - URS, were born.
When you completed your last quality audit - just how important did you consider your documentation to be? Just how clearly was the justification for your final decision on the client's cGMP compliance defined? Were you biased at all? Were all your priorities correct?
Could your decision stand up to senior management evaluation? Could it stand up to cross examination in a court of law? Are you certain that your findings are correct? All sorts of questions are asked and and allegations made when an audit goes wrong for a GMP vendor.
This why the quality of your GMP audit documentation is of paramount importance. You must always make certain that you are going to be ‘squeaky clean’, every question, and every answer and observation, needs to be clearly documented. The company priorities must be understood and integrated into the weighting of the audit documents. If you are auditing on behalf of a client, they have a right to review your completed assessment documents and agree or disagree with your verdict.
The step-by-step, systematic approach used in this audit document, makes it easy to complete the Kepner Tregoe (KT) analysis. It can be very useful where there are many potential options to consider, since the KP analysis allows you to adjust the significance or to "weigh" the importance of each attribute that is listed in the user requirements specification. Once this is action has been completed; the really important attributes can be identified and planned for.Once the KT analysis outcome is deduced and published, the complete procurement process can be accurately defined and planned.
A quality assessment questionnaire must cover the under listed topics but it must use a method of weighting the topics in order that the really critical topics have a more significant impact on the quality assessment outcome.
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 Computer Vendor Audit document should be customized using the built
in tools. The document can then be targeted to reflect your project
priorities. The fifteen chapters all contain 10 questions, the total
scored is then weighted to reflect your priorities. By assessing the
importance of each of the chapter subjects in your project, the
weighting is altered taking points from one and adding to others. This
enables your assessment to be expressed simple and clearly as a
percentage, allowing clear unambiguous comparisons to be presented for
This 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. It is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documentary evidence to demonstrate this. The PQ section gives documented verification that the equipment performance in its normal operating environment is consistently exactly as specified in the URS.