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 CVM 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 corporate validation 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 / Biotechnological / API / Medical Device, industries or whether your in any of the engineering streams that are involved with these industries, the Corporate Validation Manual will enable you to:-
The cost of the FDA Compliant, Corporate 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 Corporate 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 this Corporate Validation manual has the answers or can point to where the answers are for any validation problem you may run into.
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;
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 (weeks of work 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.
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 and associated standard operating procedures. The associated Validation Master Plan is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that all validation Online executables are catered for and that key aspects of the equipment adhere to approved design intentions and 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 documented process validation 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 URS.
The Process Validation or Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.
12000002 VrrP Equipment $298.00
This Validation 4U, 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 significant difference to the man hours required to produce and execute these standard operating practice process validation master plan executables. 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 4U costs whilst remaining compliant with their Corporate Validation Manual.
4Q Equipment Validation 4U 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 process validation Online executables documentation and associated standard operating procedures, 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, the Corporate Validation 4U Manual template is written in written in word.