VALIDATION4u



Definition Validation4u.

In validation4u, there cannot be a qualified “state” unless a qualified “state” has been defined.  In cGMP the URS defines this qualified “state” and the execution of the DQ, IQ, OQ and PQ has to be sufficiently rigorous to verify that all the requirements detailed in the URS have been complied with.


When To Apply Qualification?

Qualification must be executed against a system or entity once it is installed, commissioned and producing product that is of the expected specification. Since all the regulatory requirements are documented, the first action must be to  execute a GAP audit to establish your state of compliance.  Once your GAP audit indicates you have achieved full compliance - application should be made to your regulatory authority.  


Why Apply Validation4u ?

The Good Manufacturing Practice (GMP) Requirements are promulgated as regulations enforceable in law.  To ensure compliance there are a powerful range of penalties that can be applied to companies and or individuals who; either negligently or willfully fail to comply with all the regulations that are applicable to their activities.  


Qualification Documentation.

Image represents validation4u process in action.

Full qualification is executed against a system or entity that is installed, commissioned and producing product that is of the expected specification.  There must be no adjusting or tweaking to be done; that should have all been completed during commissioning activities.  This is the basic methodology used to introduce  pupils to the complexities of subjects like regulatory qualification.

The wording of test scripts can be tricky, but you will find that the template author has worded the essentials of the document in clear, concise and unambiguous terms allowing you to relax about such trivia and just press on following the completion instructions.

When such documents are reviewed by regulators or visiting auditors, the quality of the document is obvious and indicates to the reviewer the importance that the company gives to the quality of it’s documentation.

The FDA and regulatory authorities in general, are charged with increasing the level of compliance throughout the industry. This call for increased regulatory compliance is being driven by evidence that the industry is failing to match the standards set by other regulated industries.

Our authors have designed unique interactive documents for all qualification activities such as VMP, URS, IQ.


Recent Issues.

  1. Ensure IQ OQ PQ Template is cGMP Compliant

    Oct 01, 22 10:42 AM

    Use our IQ OQ PQ template & follow the integral SOP to edit it into your own bespoke detailed & impressive Protocol.

    Read More

  2. Ensure your Autoclave Validation is cGMP Compliant.

    Sep 25, 22 12:51 PM

    By using our interactive autoclave validation template you can quickly produce an impressive bespoke company protocol.

    Read More

  3. 21 CFR Part 211 | FDA | MHRA | EU | WHO | GMP |

    Sep 24, 22 08:19 AM

    21 CFR Part 211 defines verification boundaries, mandates validation executables, documents responsibilities, maintains URS traceability & mitigates risk.

    Read More

  4. 21 CFR Part 11 Implementation - Validation Online.

    Sep 24, 22 08:18 AM

    The intent of 21 CFR Part 11 is to ensure that predicated retention records are held in a format that renders unauthorized editing or deletion impossible.

    Read More


Process Qualification.

Validation4u inspection stage.

Process qualification requires the establishment of scientific evidence that the process is capable of consistently delivering product that satisfies all the applicable requirements documented in the User Requirements Specification (URS).

Further to this the process validation4u should not be viewed as a one-time event, but should be viewed as an ongoing lifecycle requirement. Sampling methodology should become a key factor in carrying out ongoing process qualification.

Current good manufacturing processes (cGMP) regulations specify that samples must: represent the batch under analysis and meet specifications and statistical quality control criteria as conditions of approval and release. Furthermore, the batch must meet its predetermined specifications.


Pharmaceutical Qualification.

Validation4u parameter collection.

The importance of pharmaceutical process validation4u is emphasized by the way the regulators relate all other activities relative to it. Calibration, maintenance, documented procedures, operator training, utility and ancillary service requirements are all defined by the “process”.

Since testing for conformity can often destroy or damage the product, we are; at times, totally reliant on replicating the integrity of the process for delivery of product to the exact efficacy specified.

Process validation4u ensures that all aspects of the process execution have been subjected to rigorous verification procedures verifying that the product is consistently manufactured to specification.


Documentation Structure.

 A company approved Project Quality Plan (VP) must detail the actions, deliverables, responsibilities and scope of qualification activities required for each of the identified VRA ratings. This definition and scope must be built into each Installation Qualification and Operational qualification protocol.

Change Control.
There are two stages of Change Control to be considered, there is the equipment vendor / suppliers control used during manufacture Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and commissioning. Then there is the post qualification control, which ensures that all work carried out on the validated system(s) is reviewed, and the impact of the work carried out on the system’s validated status is assessed.

Documented procedures.
Written procedures should be in place to describe the actions to be taken when a change is proposed to a starting material, product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or reproducible of the process. Change control procedures should ensure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality, consistent with the approved specifications and original validation4u.

Vendor Control.
The vendor must ensure that all changes carried out to the system during manufacture and execution of the SAT, FAT and commissioning testing, have been incorporated into the verification documentation. All drawings must be accurate, signed off, and approved. All traceability between URS documents and design specification must been maintained.

Company Control.
The company must ensure that all changes carried out to the system subsequent to the vendors actions have received approval prior to implementation, and have been fully incorporated into the system validation4u documentation. That no actions can take place that may compromise the validated state of the system.


Validation4u



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

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 validation A Plan template. As per 21 CFR Part 11.

The Installation Qualification Template 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; i.e, The User Requirement Specification template. 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this pharmaceutical validation 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 Protocol. 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 medical device validatioN  TEMPLATE or for being able to produce 4 to 8, IQ protocols per 8 hour day.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the 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.




Combined IQ/OQ/PQ for Spreadsheets. (issue-2) $159.00

This combination protocol has been specifically designed to verify that all aspects of your spreadsheet conform to best practice and that the spreadsheet layout ensures consistent and accurate use and results. The tests and inspections normally authored in separate protocols have been assembled in one protocol which is divided into three sections. This protocol enables you to verify that your developed spreadsheet application is GMP compliant, thus avoiding 483s and warning letters. You can now validate your application with minimal documentation. Equipment Validation Protocol, validation protocol template.



Design Qualification (Issue 5) -- $115.00

The Standard Operating Procedure attached to this generic design Performance qualification Template, 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



VrrP_Equipment
Issue - 4. 

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. 


12000006_4Q_Equip
Issue - 4. 

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 & Performance qualification template P1Q) 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.



Combined IQ-OQ-PQ Equipment. (Issue-8)  $159.00

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.