OPERATION VALIDATION.

Operational validation clients home city skyline photographs, this one is Glasgow.

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

This operational validation graphic is a schematic of retrospective validation documentation flow.

OPERATION VALIDATION.

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.

Quantity

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.


12000068 FAT_SAT_SOP

This combination document gives you basically 2 for 1 value. The Factory Acceptance Testing (FAT) and the Site Acceptance Testing (SAT) are very closely related. In the 'FAT' instance (which should be executed in the suppliers establishment), all aspects of design will be verified for compliance with the cGMP functionality specified in the URS. Completion and approval of the FAT, should allow shipment to point of use to be made. The SAT, must replicate the FAT plus all the additional test and inspections that are required to verify that all the 'installation specifications' as documented in the URS, have been fully satisfied. It is essential that the FAT is used to verify that all aspects of the performance Qualification template specified in the URS are working as specified, before the equipment is verified as ready for commissioning and then validation.

Combined IQ-OQ-PQ Equipment. (Issue-7) 

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.

Design Qualification (Issue 

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.

12000008 4Q Equip Package 

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.