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Document Management.

This graphic used in validation protocol standards publication.

Consistent Validation protocol standards can only be guaranteed when all documents are authored using simplified English. The need for this is becoming more apparent every-day, as more and more regulated processes; documented in English, are executed by operators located in areas; around the world, where English is not their first language. When simplified English is used it is much easier for operators and translators to ensure the original authors written instructions are replicated accurately.

Validation Protocol standards must be used for writing the Functional Test (FT) if it is to be a stand alone document that can be executed and reviewed as part of the operational qualification. The FT should first be written at the FAT stage. This means that your vendor should write it, and so the vendor does in a high percentage of instances. It is criminal that having spent hundreds of hours authoring, developing and finally executing a detailed FAT at the factory, the document is allowed to die and never be used again. For instance in a project Validation Online was closely involved in, 87 people spent nearly one year in raising, approving and executing the FAT for a Distributive Control System, while on site, 30 people spent over a year writing the OQ qualification test scripts. The FAT reviewed and condensed would have done a much better job, partly because it was written by staff, who had direct access to the design staff who designed the DCS, but mainly because it was ready, and should have been freely available from the vendor. The FAT and the FT, are the same as the re-qualifying tests that are carried out on laboratory and process equipment. It becomes a little obvious that if these documents were written to normal validation protocol standards, then, the one document could be used for the testing section in documents like, the FAT, FT, qualification and re-qualification of equipment.


Validation Protocol Standards

The following method of construction must be used. The over-all protocol standards are shown in the SOP’s for the different protocols, here we are concerned about the testing element alone. All testing must be detailed and pre-approved by a qualified person to ensure the system under test has been adequately tested. Each test must comprise of;

Main Sub-headings in Test Script.

  • A Rationale; giving the reason and or object of the test.
  • A detailed Test Method.
  • A detailed Acceptance criteria; that the tests must produce.
  • A Test Result; confirming whether the test result, satisfied the acceptance criteria.

General details that must be adhered to.

  • The test result must be initialled (or signed) by the person executing the tests, on completion or at each significant stage.
  • Each test must be designed to verify an element of the equipment functionality.
  • Each test must a have a result that is clear, unambiguous and known.
  • The test method must call up for the recording of the test result parameters. (no ticks or tick boxes, no generalities).
  • Each test must be witnessed or the results must be reviewed by a competent person.
  • The overall test results must be approved by a competent person.

Standard Protocol Inter-relationships.

Essential graphic used to depict validation template standards.g

Full Life Cycle Documentation Inter-relationships.

This schematic shows document priorities.


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Validation Documentation Matrix (Issue 6.) -- $29.00

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.


Validation Plan (Issue 8) -- $89.00

This document follows our well-developed method of using a generic document and allowing the customer to apply an attached detailed SOP to it, turning the generic document quickly into a first class company bespoke document. This VP details and integrates all validation activities and procedures required for a small to medium sized project, involving production/facility/utility equipment using electronic controls or monitoring.


SOP for Equipment Validation (Issue 6.) -- $22.00

This Standard Operating Procedure (SOP) takes you through the validation process for equipment, from the very early first stages to the final closing stage. It will ensure that your validation is seamless, that the correct documents are raised, approved, executed, reviewed and accepted correctly. It shows how to use validation tools such as the very important matrix control document and equally important risk assessments. There are ever-increasing demands on the Biotechnology and Pharmaceutical industries to meet increasing regulatory and legislative requirements, whilst improving the performance and efficiency of the business. This SOP shows the way to streamline your validation while still being fully compliant. Easing and smoothing the production and flow of protocols, so decreasing costs and delivering validation ahead of schedule. It is essential material for the new comer to validation and will direct you flawlessly through all validation tasks. For the company it is an essential SOP to add to the library. For your convenience it is written in word.


SOP for Spreadsheet Creation. -- $125.00

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 request 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 cGMP Review (Issue 3.) -- $89.00

The cGMP Review is undertaken to ensure that a design and/or facility conforms to the cGMP requirements and is fit for purpose. The requirement for Regulatory Compliance will be established during the proposal preparation.
cGMP Reviews should normally take place in accordance with the project programme. The initial cGMP Review should take place immediately after the project initiation, to define the cGMP Envelope and clarify the cGMP requirements. Additional cGMP reviews should be held towards the end of the front end design and detailed design.
It is good housekeeping practice for department heads to instigate periodic cGMP walk rounds to analyse, document and ascertain if every-day wear and tear to the fabric of the facility, is compromising the validated status of the facility.


SOP for a SOP (Issue 3.) -- $89.00

The ever sought after SOP for writing an SOP. Adopting a standard format throughout a company for the easy authoring of SOP's is of immense benefit to everyone that has to use them. Our format follows our standard company developed format of a generic template prefixed by an SOP. Follow the SOP and you quickly and simply produce a sound compliant SOP document. In this case the generic SOP template is prefixed by a SOP.


Compendium of Predicate Rules (Issue 3.) -- $85.00

The purpose of producing this document in such a concise manner, is to give a desk top reference document that can be used by authors, engineers and quality staff. It can be used in meetings, during general conversation and during telephone conversations. You first check the CPR to see what rules apply, then check out the rules in depth. You can always be sure that your documents are referenced to the correct GMP requirement.


21 CFR Part 11, Verification (Issue 3.) -- $26.00

This test script has been designed to verify whether a system or a specific piece of equipment conforms with the requirements detailed in Part11. This Test Script is not in the standard Operational Qualification (OQ), and is only available here as a direct download.


Corporate Manual Quality

The FDA has raised the bar. The rationale for change, the approach it has taken and the progress achieved are not as good as some think. In September 2003, The Wall Street Journal published an article informing all that pharmaceutical “manufacturing techniques lag behind those of potato-chip and laundry-soap makers.” The same article correlated the rise in recalls with quality problems and noted that despite fines in excess of US$500 million for manufacturing failures, acceptable levels of quality were not being achieved.
Since then, the FDA, and the industry have been actively, working together to shape the new quality requirements and standards. Compliance now requires a quality systems approach starting with “quality by design” in development and ending with scientific process control in manufacturing. So today, products are more complex; cash is scarcer; and quality requirements require more fundamental understanding. Pharmaceutical companies need to take action on each of these issues in a comprehensive manner.

The Corporate Quality Manual (CQM)is only available on DVD and is normally dispatched within two working days.



Definitive Validation Manual (Issue 5.) -- $1,160.00

This definitive 1000 + page Definitive Validation Manual arrives with you in DVD format, this enables you at any time to download protocol or test-scrip 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.