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OPERATIONAL QUALIFICATION (OQ)
Operational Qualification Rationale.This Operational Qualification (OQ) protocol comes with an interactive SOP as a prefixed document. As you complete the SOP you are auto populating the OQ. A really easy and straight forward document to use. In the preparation of the Operational Qualification validation protocols, it is important to allow a degree of flexibility. This must and should be specified in the
Validation Plan (VP). Should the OQ remain untouchable until the Installation-Qualification (IQ) is completed
and signed off? There are many instances where this is not just undesirable but senseless and deleterious to project progress
and costs. Should every function in a system or piece of equipment be qualified? It makes little sense to fail something for not reaching a parameter that you are not going to use. The Operational Qualification includes a review of the Standard Operating Procedure (SOP's) for start-up, operation, maintenance, safety, and cleaning / sanitization as applicable, must they be in fully approved format? These flexibilities must be built into the qualification process. However there is an abundance of rules and guidelines that are not flexible, and must be rigorously adhered to. The modular process has been followed in constructing this Operational Qualification, in as much that where tests / inspections are standard for systems and or equipment, they are built into the basic protocol. Where they are not they are available as test protocols. Functional and software tests are authored in this stand alone test scrip protocol format. When the OQ is being raised they are pasted in. The document format will paginate them, and automatically add them to the ‘Table of Contents’. They are
then part of the OQ. These Test Scripts can be held as Method Statements or SOP's. This allows the generation of a standard OQ that covers all the many
items the regulators are looking for, with the facility to have integrated into it, the equipment specific testing tasks. It also means that these stand alone test scripts are available for tasks other than validation, i.e. when system re-testing is required.
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It also saves unnecessary testing and re-testing. For example, when a room pressure regime has been commissioned by another party and the completed report is in date and available, is it practical and legal to use it? There is no reason why not, providing it has been authored, and executed using the same documentation practices and procedures as are used in the routine production and execution of validation protocols. The OQ test scrip will be of standard format, the contractors tests (containing the raw data) will be reviewed and data extracted from it. This data will be used to verify that the Operational Qualification test script acceptance criteria has or has not Operational Qualification Rationale.been satisfied. The raw data from the contactor now forms part of the OQ, and must be appended to it permanently, along with copy calibration certificates for all the test equipment used in obtaining the raw data.
OQ Scope.The scope of the OQ testing/inspections must include but is not limited to:
Full Life Cycle Documentation.
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Validation Master Plan (Issue
7) -- $115.00
This document follows our proven practice of supplying a interactive generic document with an automatic method of populating it. Once populated, all you need to do is follow the prompts in the attached SOP. They will take you through the completion process section, by section. At the end of this process your generic document has progressed into a detailed, referenced, bespoke company document. The document follows our three level URS system that ensures functionality traceability from the URS to the various testing protocols. This document interfaces with our Validation Risk Assessment (VRA), Validation Project Plan (VP), User Requirements Specification (URS), giving a seamless flow from your VMP through the VP - IQ - OQ - PQ, while integrating flawlessly with the URS - DQ - VRA.
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Validation Plan (Issue 8) --
$89.00
This document follows our well-developed method of using a generic
document and allowing the customer to apply an attached detailed SOP to it,
turning the generic document quickly into a first class company bespoke
document. This VP details and integrates all validation activities and
procedures required for a small to medium sized project, involving
production/facility/utility equipment using electronic controls or
monitoring.
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User Requirements Specification
(Issue 7.) -- $115.00
The document that sets the standard, and specifies your
requirements in a manner that ensures when a system or piece of equipment is
selected, it will deliver the functions you want, it will have maintenance
standards, it will have calibration records, it will have all the documents and
records to enable successful validation to be completed. 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 URS through to the final PQ and OQ
functionality testing. This is a
mandatory requirement for Full Life Cycle Validation (FLCV) of computer systems
that are the subject of predicate rules. It can be used on mechanical,
electrical and software controlled, monitored or managed systems.
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Design Qualification (Issue 4.)
-- $115.00
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.
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Installation Qualification. SOP
& Protocol (Issue 9.) -- $115.00
The SOP used to generate this 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. There is now no reason for
not being able to produce 4 to 8, IQ protocols per 8 hour
day.
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Operational Qualification, SOP
& Protocol (Issue 10.) --$115.00
You will find the step by step attached SOP 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
Operational Qualification Protocol. 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. Template for VMP.
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Performance Qualification (P1Q)
(Issue 5.) -- $89.00
The Performance Qualification is the last of the qualifying tests
that equipment and processes are subjected to, prior to the actual first product
run. It maybe that there are some steps in the process that can only be verified
by actually running them (quick freezing and sublimation, to mention only two)
or it sometimes is the fact that the product is a very expensive product, and
cannot be wasted. So no one wants to run the process with product, until they
are completely certain there will be minimal waste. Template for VMP.
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Process Qualification (P2Q)
(Issue 3.) -- $85.00
The Process Qualification is the culmination of the validation
process. The protocol is used in conjunction with the SOP for the process, to
run three batches through the process being qualified and verify that the
process consistently produces product to within the process specified
tolerances. The results of the process must be recorder and reviewed with a view
to ensuring that the deviancies (within permitted tolerances) that exist are
random and not a trend that will lead to out of specification produce being
produced.
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Validation Risk Assessment
(Issue11.) -- $125.00
The Risk and Part 11 Validation Risk Assessment (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 VRA now includes the assessment table for categorising 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. Template for VMP.(now mandatory).
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