This Corporate Quality Manual (CQM) is supplied written in Microsoft Word, preloaded to a USB memory stick and complete with the attachments listed in the graphics below. These high quality documents, protocols, plans and SOPs templates are all deliberately written in Microsoft Word - specifically to allow easy editing for the end user. Each document is preceded by an SOP which
prompts you through the procedure of populating and then converting your template, into your own bespoke company document.
This CQM has real live detailed, compliant and interactive documents. These documents were designed by use and have been subjected to a continuous process of evolution. Incorporating the latest in legislation changes and regulatory expectations. Without a doubt these documents represent represent the most Cost Effective method of producing all the required protocols, plans and SOPs that are mandated in any validation task. They will free up a lot of your time and enable you to
deliver your validation projects and tasks in budget and 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 an outstanding resource to have.
Continued feedback indicates that these are the best FDA Compliant document templates available anywhere.
If you have background knowledge in pharmaceuticals and are reasonably competent, the Company Quality 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 QC Manual will enable you to:-
The cost of the FDA Compliant Corporate QC Manual, will be recouped in the first few weeks, it will then go on to show a massive
return on your original investment.
An investment that you will never ever regret.
The GMP Corporate Quality Manual is the start of all compliant documentation. The policies container in it, dictate what documents must be raised and details the scopes and responsibilities in raising, approving and executing them. Here both our QC and QA manuals go a great deal further, in containing interactive downloadable templates for, Validation Master Plan (VMP), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), User Requirements Specification (URS), and many more documents, all of which are compliant with Good Manufacturing Procedures GMP, GAMP 4, Food and Drug Authority (FDA) and Medicines and Healthcare Regulatory Agency (MHRA), rules and regulations. Authoring and publishing a Corporate Validation Manual is a long drawn out and expensive process. A single author will usually take six to nine months to produce one. A similar amount of time is required from peers, in reviewing and editing.
Our Corporate Quality Manual preface is constructed in the format of an Standard Operation Procedure - SOP - as an SOP. This SOP takes you through the simple stage of populating the Corporate Validation Manual. This standard manual is now your new company bespoke manual.
This Qualification, 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. Resulting in the document becoming notably easier to use and quicker to review and amend. 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 sacrificing regulatory compliance.
This new 4Q Equipment Validation Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the these four protocols and carefully weaving them into one notably easy to use protocol, we have made significant progress in reducing validation paperwork. Reductions of up to 75% have been quoted as the likely total. Integrating the old style DQ/IQ/OQ/PQ protocols into one 4Q document will be an enormous savings in man hours in the authoring, reviewing, updating and approving tasks. With the simultaneous introduction of the new Validation risk & Requirements Plan (VrrP) which integrates the VP, VRA & URS into one document - equipment validation has been reduced to two document.
This quite revolutionary two document package is all that is required to fully validate; to cGMP standards, equipment used in a regulated facility. A lot of effort has gone into ensuring that repetitive instructions and actions have been designed out and innovative and intuitive risk-based methodologies have been incorporated. Both documents are prefaced with a methods Standard Operating Practice (SOP) document. These SOP’s lead you through the task of converting these highly detailed templates into your very own company bespoke protocols. The hyperlinks and cross-references within the package are; not only unique, but also highly cost effective and intuitive to use. Each document is preloaded with the test scripts (complete with acceptance criteria). All test and inspection scripts are written in MS word, to facilitate simple editing of text, layout, tables and schematics.
This document was specifically designed to be compliant with the all of the FDA, EC and WHO legislation and guidance documentation and over 1700 have been used in submissions to regulatory authorities. This combined IQ/OQ/PQ protocol along with the appropriate interrelated plans and assessment documents will not only validate the item under qualification but it will also produce the thorough audit trail needed to meet all internal or external regulatory reviews and or inspections.