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 contained in it, dictate what documents must be raised and detail's 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 5, 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.
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online 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 Risk Mitigation in Validation template.
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).
This Pharmaceutical Validation 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 and associated standard operating procedure TEMPLATE. The associated medical device validation Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the medical device validation template; The User Requirements Specification template
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template.
You will find this validation online intuitive Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.