To edit this validation operational qualification template into a inclusively clever protocol - Simply follow the integral SOP
Edit our Operational Qualification Template into your own Protocol
Operational Qualification Template (Rationale).
Simply procure a cGMP compliant Operational Qualification template & follow the integral SOP to edit it into your own cGMP compliant, bespoke & impressive Protocol Operational Qualification template (OQ) protocol comes with an interactive standard operating practice (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 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 only 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 template includes a review of the Standard Operating Practice (SOP's) for start-up, operational, maintenance, safety, and cleaning / sanitization. The modular process has been followed in constructing this Operational Qualification template, 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 additional 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 Operational qualification template. 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 template test script acceptance criteria has or has not Operational Qualification template 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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Operational Qualification Template (Scope).
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 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. Template for VMP.
The scope of the OQ testing/inspections must include but is not limited to:
- Verification that all operational qualification template identified loops are calibrated.
- Insert a brief description of what part of the validated product process.
- Insert a brief description of the operational 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 Life Cycle Documentation.
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Validation Risk Assessment (Issue 11) $125.00
Risk Mitigation in Validation template (Issue 11) $125.00 The Risk and Part 11 Validation Risk Assessment(VRA) protocol is becoming the most important document in the validation online 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 Risk Mitigation in Validation template.
This VRA 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).
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 Risk Mitigation in Validation risk Assessment template. As per 21 CFR Part 11.
The Installation Qualification Template or IQ 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; The User Requirements Specification template
Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020
The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (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 template. 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 current Good Manufacturing Practice use medical device use or a simple installation qualification template.
Operational Qualification, SOP & Protocol (Issue 10.) $115.00
You will find this validation online intuitive 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, along with the installation qualification template.
Operational Qualification Template (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 Template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific Operational 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 Template for VMP.
Validation Plan (Issue 8) -- $93.00
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.
User Requirements Specification (Issue 8.) -- $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; i.e. it will have maintenance standards and methodologies; 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 Operational qualification template 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.
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.
Installation Qualification (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.