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. This high quality manual along with all associated 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 Corporate Quality Manual 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 user 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 Corporate 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 Corporate Quality 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 and Medicines and Healthcare Regulatory Agency, rules and regulations. Authoring and publishing a Corporate Quality 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 as an SOP. This SOP takes you through the simple stage of populating the Corporate Validation Manual. This standard could be considered a training manual or even a user manual and becomes your new company bespoke manual.
For Your Security We are Now TLS 1.2 Compliant
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document. The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement. Safety and security along with user operability are very detailed. The document will lead you through all these design aspects allowing you to delete some you feel are not important to your equipment. It is an easy document to use and will ensure that you’re DQ’s are relevant, up to date and easy to execute. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained
This Validation 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.
4Q Equipment Validation4u 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
validation4u documentation 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, it is still written in word and compliant with FDA GMP Part 11 legislation.
This quite unique 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 and are compliant with FDA GMP Part 11 regulations.