This Corporate Validation Manual (CVM) is supplied loaded to a memory
stick (MS) and complete with the attachments that are listed in the
graphics below. These high quality documents and protocols are all
constructed in Microsoft Word. Each document is preceded by an SOP
which prompts you through the procedure of populating and then
customizing the template, into your own bespoke company document.
This MS has real documents, detailed, compliant and interactive, but
most of all - Highly Cost Effective. These document have evolved
through over thirty years of joint validation expertise, they will free
up a lot of your time and enable you to deliver your validation projects
and tasks on time.
For the validation professional, this manual is an extremely useful tool, for the new comer in validation, it gives a huge boost to confidence and actually makes you look good. To have this material on hand is incredible and to be able to download and populate an IQ in minutes, or six IQ’s in an hour, is quite awesome. Remembering always that these are the best FDA Compliant document templates available anywhere.
If you have background knowledge in pharmaceuticals and are reasonably competent, the Corporate Validation Manual will do the rest for you. If you are in the Pharmaceutical /
The cost of the FDA Compliant, Company Validation Manual, will be recouped in the first few weeks, it will then go on to show a very healthy return on your original investment.
An investment that you will never ever regret.
It would appear the established colleges have not managed to establish validation as a separate subject, yet they have been slow to integrate into existing courses knowledge of GAMP 3/4/5 , or GMP's, or 21 CFR Part 11 , or EMEA 726-2004 . Degree qualified persons looking for employment in the pharmaceutical and medical device manufacturing industry arrive in production plants with little or no comprehension of FDA or MHRA or WHO rules and requirements.
Validation is the number one priority in these plants, fall down on your validation and the regulators (FDA / MHRA / EMEA/ WHO) can fine you, remove your approval to manufacture, or even close you down. Losing your manufacturing rights for a drug that has taken hundreds of millions to develop, is catastrophic, even to the major international companies. Good validation ensures that this does not happen.
Validation is a mixture of skills, and the manual is designed to interlink with your existing skills and add the required mix of Quality, Instrument, electrical and mechanical knowledge to enable you to work as a validation technician or engineer or consultant in the pharmaceutical or biotechnological or API or Medical Device, industries.
In validation you are not designing, you are verifying that equipment or installation and use; conform to certain standards. This involves authoring a document train that starts with the URS follows with IQ / OQ and usually finishes with the PQ, normally difficult and complex documents - but in your case - they are all on the manual Definitive Validation Manual DVD, ready for you to download. Using the manual is a great way to receive training while maintaining full time employment, and to feel confident that the manual has the answers or can point to where the answers are for any validation problem you may run into.
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Equipment combined IQ/OQ/PQ Protocol. $159.00
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.
This Validation, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a very significant difference to the man hours required to produce and execute these documents. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation costs without infringing regulatory standards.
4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, it is still written in word.
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.
The Performance Qualification is the last of the qualifying tests that equipment and processes are subjected to, prior to the actual first product run. It maybe that there are some steps in the process that can only be verified by actually running them (quick freezing and sublimation, to mention only two) or it somtimes is the fact that the product is a very expensive product, and can not be wasted. So no one wants to run the process with product, until they are completely certain there will be minimal waste.