This Operational Qualification (OQ) protocol comes with an interactive standard operating procedure (SOP) document as a prefixed introductory document. As you progress through this SOP you are auto populating the OQ. This is a really easy and straight forward document to use. In the preparation of Operational Qualification validation protocols, it is important to allow a certain degree of flexibility. This must be debated and justified 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? If so, one must ask about validation progress and costings. 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.
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 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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Validation Master Plan (Issue
7) -- $115.00
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.
Validation Plan (Issue 8) --
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