OPERATION VALIDATION.
Operation Validation Definition.
"Execution of the Operation Qualification protocol must produce sufficient data to verify that; all the operation functionalities mandated in the User Requirements Specification, have been fully complied with."
Operation Validation Rationale.
This Operation Validation must be verified with the execution of a Operation Qualification (OQ) protocol. This is 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 Operation Validation must include 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 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.
Rationalizing of Inspection and Test Occurrences.
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 Operation Validation test script acceptance criteria has or has not Operation Qualification Rationale.been satisfied. The raw data from the contractor 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.
Where you use your own indigenous testing methods contained in an SOP or a Method Statement (or whatever you decide to call them), they must be used in a manner similar to the manner the contractors raw data was used.
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Operation Validation Scope.
The scope of the OQ testing/inspections must include but is not limited to:
- Verification that all loop installations;
- Insert a brief description of what part of the validated product process.
- Insert a brief description of the operation function.
- An integrated loop test verification.
- Testing of alarms.
- Testing of interlocks and permissive conditions.
- Testing of database or data storage integrity.
- Testing of report generation and event chronicle.
- Verification of the functionality of the equipment.
- Challenge of software, where required;
- Review of system functionality to verify compliance with 21 CFR Part 11.
- If system must be 21 CFR Part 11 compliant, verification;
- Testing of security levels to prevent;
- Testing to verify and document Power
loss Recovery.
- Testing of all interfaces between;
- Testing for
Electromagnetic interference and compatibility.
Full Validation Life Cycle Documentation
Vendor Audit Package $199.00
When goods or services are purchase by a cGMP approved organization from a none cGMP approved vendor; it is a legal requirement that the would-be purchaser audits the supplier to establish the scope of any work required to render the item or process cGMP compliant
This elevates the Vendor Audit (VA) Document to a “Must be in Place” status. So, your list of pre validation doc's must include: (VA) + (FAT) + (SAT)
These are mandatory & available as a package;
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 hard copy, and
Part 11 does not apply.
After numerous requests 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.
Combined IQ/OQ/PQ Equipment. (Issue-7) -- $159.00
Equipment combined IQ/OQ/PQ Protocol.
This 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. It is interactive, easy to use
and suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that key aspects of
the equipment adhere to approved design intentions and that the
recommendations of the manufacturer have been suitably considered. The
OQ section establishes that there is documented verification that the
installed system functions as specified and that there is sufficient
documentary evidence to demonstrate this. The PQ section gives
documented verification that the equipment performance in its normal
operating environment is consistently exactly as specified in the URS.
Combined IQ-OQ-PQ Equipment. (Issue-7) $159.00 10000005
This three-part, cGMP compliant, protocol template will arrive with you: fully detailed, with all test scripts, rationales and test methods laid-out in accordance with regulatory expectations. First issued as an equipment-validation document; end-user demand quickly forced us into widening the scope of IQ-OQ-PQ (formated protolcols - click to view).
This combined IQ-OQ-PQ protocol along with the appropriate interrelated plans and assessment documents will not only validate the item under qualification, but it will also ensure that the detailed audit trail needed to meet all internal or external regulatory reviews and or inspections is produced.
More IQ/OQ/PQ Protocols.Corporate Quality Manual
$1,160.00
This Corporate Quality Manual (CQM) is the top tier of our documentation system. It gives an overview of our Quality System. It is supported by corporate and division standard operating procedures (SOPs) which are the second tier of our Quality System documents and are listed in this Quality Manual. The third tier of the documentation system consists of manufacturing / documents, forms & specifications developed by each operating unit.
Mandatory document
Design Qualification (Issue 5) -- $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
12000002_VrrP_Equipment_iss-4. -- $298.00
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_iss-4. -- $298.00
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 & PQ 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.
12000008 4Q Equip Package $499.00
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.