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Retrospective Validation Rationale.

Retrospective Validation causes a great deal of controversy, however do not be backed into a corner by over zealous consultants, there are many instances when retrospectively validation has to be undertaken.
Some of the reasons we have encountered are listed below. This is in no way meant to be a definitive list;

  1. Resurrecting an out-of-use facility.
  2. The initial validation was weak.
  3. New product has higher risk assessment therefor validation scope must be reviewed accordingly.
  4. It was thought it did not require validation.
  5. Initiate a requirement for re-validation to be carried out on a calendar bases.
  6. Health and safety legislation has changed.
  7. FDA rules and or guidelines have changed.
  8. Poor advise from consultants.

In most cases it is necessary to start with a validation plan, in which the scope, the action being taken and the responsibilities can be detailed. From then on use the standard layout for your IQ's and OQ's. When the IQ and OQ are completed and the P1Q, and where required, P2Q, ensure that use an abundance of production data, produce and review plenty of it. However if the existing production data shows that the process is not consistently producing in accordance with the process specification, then you must sort out the process first. Review the whole process and ascertain where and what is causing the inconsistencies to occur. Validation is not an exercise to get the process right. You validate once your process is consistently producing product to the expected specification. Once you are certain of this, then start your validation procedure.

Do not forget that validation is all about documented evidence. If this is a retrospective validation you will have records of the performance of the subject equipment, use them fully. Use your Validation Risk Assessment to define the validation scope and author your protocols accordingly.

Planning board used in the preparation of all retrospective qualification executed.For further information click anywhere on image.

Retrospective Validation Methodology.

Use your Validation Risk Assessment to define the validation scope and raise your protocols accordingly.
If this system has never been validated, then you have no alternative, you must raise the full Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification PQ and perhaps Design Qualification DQ, get them approved and then execute them.
If this system is being re-validated because of discrepancies with the original validation. Then you should raise a Supplementary IQ and OQ, or in an instance where the system is small or very simple, a combined IQ/OQ. In the supplementary protocol you can review the existing validated status and list additional tests / inspection as you think necessary.
Think well before going down this road, it does highlight to a regulator all the things that were missed in the original validation exercise. The paperwork trail can become messy between original protocols and supplementary protocols. It is often best to declare that a validation review (for any of the listed reasons) is to be carried out. On the bases of the review outcome, revalidate equipment as required. Keeping the paperwork nice and simple.


Validation Risk Assessment (Issue 11) $125.00

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).

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 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 

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

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. 

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

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.

SOP for Spreadsheet Creation. -- $125.00

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous request for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.