HOW TO USE VALIDATION RISK ASSESSMENTs WITHIN cGMP REQUIREMENTS



Validation Risk Assessment Template (Issue11.)$125.00

The Risk and Part 11 Validation Risk Assessment template (VRA) protocol is becoming the most important document in the validation 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 validation activities.

This Validation Risk Assessment template 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).



Incorporating Validation Risk Assessment template (VRA)

A predicate data record does not required to be Part 11 compliant; unless it is the master copy of the predicate data and is stored in an electronic format. Validation Risk Assessment.

A properly designed and precisely executed VRA analysis has proved over and over again to be key to the expedient completion of any FDA, WHO and or EU compliant; risk based validation project. Our latest issue of this Validation risk assessment template (VRA) document (issue 11) reflects these principles and also incorporates the very latest in regulatory mandates and legislative guidance document comments. The execution of this VRA not only defines and documents the scope of your validation activity; it also prompts you into documenting how each Part 11 record is evaluated and how it will be managed. This brings you into compliance with the mandate in the latest Part 11 clarification documentation. This is now a mandatory requirement and these justifications form regulatory reviewable documents.

This new found freedom to assess records and set justified management of them would appear to mean that the original all embracing approach to all electronic records is to be dropped and the full rigors of part 11 applied only to the data that directly affects product quality, safety, and records (of the product) integrity.

"For those records that are to remain the subject of part 11, we will apply discretion in the validation of audit trails, record retention, and record copying."

This would appear to mean that if your in-house document control is secure and robust; then it will be acceptable in the matter of audit trail / record retention and record copying.

"We will enforce all predicate rule assessments, including predicate rule record and record keeping requirements."

This is a statement to the effect that in all other ways 21 CFR Part 11 will be enforced.

Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).

This is a new requirement for a database of predicate (all) data records, giving a documented and approved justification for the method of storage.  Basically separating them into section such as number:

1.         Is not predicate data.

2.         Is a predicate data, not require to be stored in compliance with Part .

3.         Is predicate data, must store compliant current Part 11 requirements.

 

New Interpretation:

A predicate data record does not required to be Part 11 compliant; unless it is the master copy of the predicate data and is stored in an electronic format. 

I.E. if the record is derived from an electronic source and is downloaded into a hard copy format; which then becomes your master copy of the record.  This paper copy is not subject to Part 11 requirements; but must comply with all the other rules and regulation governing the management of predicate data records.


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Validation Risk Assessment Template (VRA) Introduction.

First we have to look at validation and how the level of validation as judge by validation risk assessment, can be varied independently of the scope.

The question - How much validation? - has been an open subject for many years. Numerous companies brought in validation consultants, and or regulatory compliance experts, to guide them through these problems, but every so often, there would be clashes, or at least variations in opinion, in what the appropriate scope and depth of validation was. It was understood and accepted by the regulators that there was equipment in use, that full validation was inappropriate for, yet the design or misuse of that piece of equipment could affect product quality, so some degree of validation was required.

The more typical production equipment is mainly mechanical (but often intricate and complex), but frequently uses electronics to monitored and or managed it’s functionality and or record retention systems. Then at the very pinnacle of validation we have the mainly electronic systems running extremely complex sophisticated software programs or systems where the software manipulates data and accepts or rejects product quality base on the outcome of the data manipulation. All these systems play a major role in the product manufacturing process, they all require thorough validation using the existing framework of IQ – OQ - PQ, but they do not all require the same level of validation risk assessment template. How do we define the appropriate level?

Risk Based Validation

When we move away from these simple devices, to the average type of production equipment. Here we find a range of equipment varying from purely mechanical (but often intricate) equipment, to mechanical equipment assisted and or monitored and or managed by some degree of electronics. Then at the very pinnacle of risk based validation we have the mainly electronic systems running extremely complex sophisticated software programs. All these systems play a major role in the product manufacturing process, they all require thorough validation risk assessment template using the existing framework of IQ – OQ - PQ, but they do not all require the same level of validation. How do we define the appropriate level?

First we have to look at validation and how the level of validation can be varied independently of the scope. If we list all the tasks we consider essential to complex software driven equipment validation, then drop off the tasks we consider inappropriate to the next level of equipment complexity, and so on. We appear to have four levels, with a significant step change between each of them.

  • Mechanical/electronic/electrical/full life cycle software, validation.
  • Mechanical/electronic/electrical/software, validation.
  • Mechanical/electronic/electrical/software, calibration.
  • None

The requirement for 21 CFR Part 11 compliance, can occur at all three of the upper levels of validation and so is addressed in the Validation Risk Assessment template as a separate requirement. To find that a piece of laboratory equipment requires the same degree of validation as a Distributive Control System may be disquieting, however any equipment that uses software alone, to automatically derive whether the product passes, or fails to pass, an inspection stage, must be subjected to FLCV. The laboratory equipment may have one such stage, the DCS will have many, however, one or many, the software lineage for each system, must follow similar methodologies.

Our Validation Risk Assessment template (VRA) takes you through this assessment process and enables you to make a documented and justified decision as to the level of validation each piece of equipment will receive. This fulfils your obligation to ensure that all software is assessed, as to FLCV applicability.


Image represent validation risk assessment products.

Validation Risk Assessment template Scope.


This Validation Risk Assessment template (VRA) will take you through the under listed points and allow you to make accurate justifiable assessments of risk for any system or piece of equipment. This will enable you to adjust your level or scope of validation effort and deliver soundly based validation risk assessment template methodologies.

  • Outline.
  • Approvals.
  • Determination of Classification.
  • Prospective Validation.
  • Retrospective Validation.
  • Impact Assessment.
  • Impact Assessment Process.
  • Validation Risk Assessment template Scenario.
  • Likelihood.
  • Impact Severity.
  • Probability of Detection.
  • Impact Priority.
  • Impact Mitigation.
  • Assessment of Change.


VALIDATION RISK ASSESSMENT Template.



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.



Design Qualification (Issue 5) -- $115.00

The Standard Operating Procedure attached to this generic computer design qualification protocol, will chapter by chapter take you through the task of raising a fully detailed protocol. The main body is split into fourteen tables, each one probing the computer design requirements and standards for the individual requirement. Practically all the requirements are in table form. Allowing fast and clearly presented results to be obtained.

Quantity

Validation Plan (Issue 10) -- $93.00

The VP must specify methodologies, assign staff, designate responsibilities and give specific guidance on any contentious or ambiguous aspects of the VP validation task. Where it makes commercial sense and is compliant with cGMP rules and regulations; each VP can be written to cover multiple items.