CORPORATE VALIDATION MANUAL.


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Corporate Validation Manual Scope.

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 /

Biotechnological / API / Medical Device, industries or whether your in any of the engineering streams that are involved with these industries, the Validation Manual will enable you to:-

  • Run large validation projects.
  • Promptly produce compliance documentation.
  • Get started in pharmaceutical validation.
  • Gain promotion in the industry.
  • Become dual skilled.
  • Get into the highest paid section of the industry.

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.


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Corporate Validation Manual CHAPTER 1 TO 13 HEADINGS.

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Corporate Validation Manual Usage.

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.


Appended Validation Test Scripts.

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CORPORATE VALIDATION MANUAL.



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SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00

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SOP Equipment Validation.

The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.


Purchase your copy now at Special Price of $22.00.

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Validation Risk Assessment (Issue11.) -- $125.00

The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation 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 validation activities.
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).

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Equipment combined IQ/OQ/PQ Protocol.

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.

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