This Corporate QC Manual (CQCM) 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 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 QC 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 QC 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.
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The Validation Master Plan (VMP) must present an overall picture of the company facility, organization and capability. It must give a clear and concise overview of how the company has integrated all applicable cGMP requirements as specified in 21 CFR Part 11, 210, 211 and 820 into its operations. It must define validation activities and allot responsibilities for authoring, reviewing, approving, and executing validation documentation and tasks. It must mandate the production of all Practices and Procedure manuals and SOP's.
The VP must document all methodologies, boundaries and responsibilities, along with defining validation limitation and scopes. It is a master reference for all validation variables and queries.
When you declare that your validation is Risk based; then it is incumbent on you to use a suitable tool to convert the perceived level of risk to an appropriate intensity of validation. 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 rulings.
During a regulatory visit the inspectors do expect to see a complete suite of validation documents in place for each validation task. The use and scope of the individual documents has been documented, discussed and explained in detail. It is therefore obviously best policy to have in place exactly what the regulator is looking for. The use of a document packages ensures a multitude of regulatory requirements are catered for and possibly a similar multitude of pitfalls, blunders and omissions are anticipated and negated