oq-iq pq roles- gcp system compliance
TRANSCRIPT
OQ, IQ, and PQ Roles & Responsibilities for a Common Sense Approach to GCP System Compliance
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Dr. Stokes worked as a Medical Technologist inhospitals, researches, and central laboratories.Her transition to computers came fromtroubleshooting systems reporting laboratoryresults. She joined Digital Equipment Corporation(DEC) for a 16 year career focused onpharmaceutical computer solutions. Based inBasel, Switzerland 1990-1995, she developedDEC's computer validation consulting practice forcustomers across Europe and in Japan with afocus on reality-based compliance to global goodpractice ,regulations.
Instructor Profile
The full life cycle of a regulated softwareapplication and its platform system. As shown inthe figure, there are three separate CSV packagesto be prepared at the start up of a newcomputerized GCP system. the performancequalification (PQ) package, the installationqualification (IQ) package, and the operationalqualification (OQ) packages.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
In this webinar we will know about
What do OQ, IQ, and PQ mean for GCP system compliance to Part 11 and Annex 11? Is there an industry standard model for a system validation package? What are the roles and responsibilities for software supplier, IT infrastructure provider, and end users of GCP application systems? How does Cloud technology impact the validation process? What is management's role in the computer validation and compliance process?
Validation packages :
There are three streams of validation work that must be controlled anddocumented within each package. With documented human control and systemcontrol in place, the successful validation team moves to formal testing of thesystem.
There are three types of validation packages produced in a regulated software lifecycle.
Operational Qualification (OQ) – Documented evidence that a system operates asintended throughout its expected range as per design specifications.
Installation Qualification (IQ) – Documented evidence that all systemcomponents are installed to supplier instructions & user requirements
Performance Qualification (PQ) – Documented evidence that a system operatesas intended in the user’s work process.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Why should attend this Webinar ?
This webinar teach validation ofcomputer packages, based onproject experience and tell thetechnique to adapt the softwaresuppliers and end users. It providesthe traceability, from package andstandard documents.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Objectives of IQ :
IQ - Installation Qualification
During the first stage, the process equipment, along with supporting and sub-systems, are inspected to ensure they conform to the requirements of the manufacturer and are installed appropriately. The moulds are validated for their ability to create parts that adhere to strict dimensional, economical and performance necessities.
A few factors that are given consideration during IQ include the installation conditions, design features of the equipment, the conditions of the given environment, and any documents, illustrations or manuals provided by the supplier.
Once installation and design specifications are met which can repeatedly produce parts that will perform up to standard, the process validation can continue to OQ.
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Objectives of QQ :
OQ - Operational Qualification
This stage tests the newly installed equipment to ensure it operates as expected, and gauges the conditions under which it will continue to do so. Test runs will determine the highest, lowest and nominal operating processes by varying the pressures, temperatures, velocities and other factors from the initial process arrived at during IQ.
Factors considered during OQ include the process control limits, the raw material specifications, the requirements for handling the materials, training, and the short term stability and capability.
If Operational Qualification is successful, it will validate that all aspects of the equipment perform as expected under various conditions.
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Objectives of PQ :
PQ - Performance Qualification
During Performance Qualification, the equipment will be run several times. Real manufacturing materials will be used, and the equipment will be allowed to cool between each run, to verify that the injection moulding process is capable of consistently producing quality products at a range of operating conditions, established during the OQ part of the process.
Considerations during PQ include long term stability, and whether the products produced under the expected levels of operating conditions consistently perform to standards.
At each phase of the validation process, documents must be drawn up which detail inspection results, parameters settings, and any deviations from the expected performance and the reasons for them. Only after IQ, OQ and PQ have been successfully completed, and documents are produced which verify the acceptability of every phase of the injection moulding validation process, can production get underway. This detailed process has proven to be the ideal way to guarantee the best quality parts, time after time.
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Who will Benefit ?
www.onlinecompliancepanel.com | 510-857-5896 | [email protected]
Software Developers, Testers, and other Supplier professionals new to the GCP regulated market. QA/QC and IT professionals new to the GCP regulated market. Software System purchasers/Owners and other professionals new to the GCP system compliance and audit experience. Developers of EDC, Diary/EPRO, IVRS/IWRS, and other clinical trial systems
How this Webinar works ?
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Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat
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