Installation qualification iq, operational qualification oq, and performance qualification pq are a set of industry standard terms for validation, and is often affiliated with software validation. Oq and performance qualification pq, essentially a series of tests and. Sterlings experience with iqoqpq sterling has helped hundreds of devices go through the proper medical device qualifications to ensure they meet the proper regulations for gmp. Besides, all of these practices considerably cut down errors so that the product quality can be maintained in accordance with the relevant regulations and industry. The iq records the installation of the software, and ensures that the installation follows the correct steps. Pq has to be related to the user requirements specifications. Operational qualification, also called as oq is the next activity of the software validation process after the successful completion of iq. What are qualification protocols in riskbased software. The fda defines iq as establishing confidence that process equipment and ancillary systems are. Ofni systems provides your fda regulated business with software and products to assist with 21 cfr 11, annex 11, hipaa, and other regulatory requirements for electronic data and signatures. Traditionally, companies implemented an installation qualification iq, operation qualification oq and performance qualification pq, essentially a series of tests and documented evidence of the testing. Writing effective iq oq pq protocols is a must for following the regulations required by the fda for equipment, systems, and utilities to demonstrate suitability for the intended use and to operate according to their design and functional specifications.
Process validation for medical device manufacturers youtube. Process validation is the verification that a process meets the requirements imposed on its process results. Kevin ballarddirector of software validationmastercontrol. Establishing confidence through appropriate testing that the finished product or process produced by a specified process meets all release requirements for functionality and safety and that procedures are effective and reproducible. While all the test and inspection stages are purposely targeted at the validation requirements of the specific item under qualification. Sterling is able to use its experience with these devices to help clients meet these qualifications faster, leading to clients saving time and money during their. As testers we all know that the software development team develops the software inhouse as per the software. Before you even get to iq, oq, pq, if youre acquiring a new piece of equipment, youll need design specifications that define. Shaila shaheed senior project manager fda linkedin. As testers we all know that the software development team develops the software inhouse as per the software requirements specification srs, functional specification and later the testing team verifies the implementation at different levels of testing at various testing environments, from simplest to. If you are reading this blog you may also be familiar with medical device and life. Iq oq pq or installation qualification, operational qualification and performance qualification are 3 independent and documented procedures used together to check and test that a mechanical, piping or. Aug 18, 2015 the 1 in p1q is to avoid confusing it with process qualification pq, which is used in process validation to verify the capabilities of processes. What are iq oq pq, the 3 qs of software validation process.
Every step of every module or process should be executed to the users satisfaction, including both regulatory and unique customer requirements. Aug 03, 2017 the system of gmp necessitates the practices of iq, oq and pq for equipment qualification process. What are iq oq pq and why are they critical to the. Participants will work in focused teams to complete. The oq design study identifies the range of kpiv variables which produces product which meets predetermined acceptable specifications. This includes but is not limited to sterilisation and sterile packaging. The iq protocol is a document that describes how to verify that the system has been correctly installed. Sop development and implementation, training, iqoqpq process, final validation reports, final fda 21 cfr part 11 validation approvals and maintenance and followup services. Installation qualification report iqr an installation qualification report is a report which documents the preliminary conclusions, execution summary, iq activities summary, any deviations, and product disposition of the iq qualification. Understanding iq, oq and pq for medical device manufacturing processes.
A performance qualification pq is a testing protocol which provides documented evidence that the equipments production runs at the predefined acceptable range of kpiv variables produces products which meet prefined acceptable specifications. A performance qualification pq is a testing protocol which provides documented evidence that the equipments production runs at the predefined acceptable range of kpiv variables produces products. Iq oq pq or installation qualification, operational qualification and performance qualification are 3 independent and documented procedures used together to check and test that a mechanical, piping or software system is. Participants will work in focused teams to complete handson validation activities through instruction, exercises, and case scenarios. Iq, oq, pq a validation process in the medtech industry. Installation qualification iq simply put in guidance, is everything installed correctly. For fda purposes, this guidance applies to any software related to a regulated medical device, as defined by section 201h of the federal food, drug, and cosmetic act the act and by current fda. The operational qualification oq the performance qualification pq these qualification protocols are used to ensure that all necessary tests and checks are performed to verify that the hardware, associated infrastructure, and software are in place and documentedas required by both your own internal standards, those of the software vendor.
If you are reading this blog you may also be familiar with medical device and life sciences specific acronyms for example iq, oq, and pq. Medical device software validation, software validation. In one case, we obtained approval from a client in february, specd out the equipment, received it in march. This is a mandatory requirement for full life cycle validation flcv of computer systems that are the subject of predicate rules. Operational qualification tests functional elements and insures that the system will meet all defined. What are iq, oq, and pq, and why are they required in the. The pq is a list of tests, performed by independent personnel with each test performed multiple times. Sterling has helped hundreds of devices go through the proper medical device qualifications to ensure they meet the proper regulations for gmp. Iso 485 compliant ms word and excel formats includes related forms and control charts.
The fda definition of performance qualification is. It helps manufacturers ascertain a consistent quality delivery from the equipment. Best practices for instrument validation and qualification. Quite often, the basis for the iq and oq will be the equipment manual itself. Jan 29, 2018 the iq, oq, pq and their impact on quality control there are some constants that cannot be ignored, even between two radically different products. Jun 06, 2016 this video provides regulatoryquality professionals, manufacturing engineers, and process development engineers with the knowledge and skills needed to comply with the process validation. Oq tests can also include confirmation of any design elements not tested during iq, such as configuration, are working as specified. For fda compliant validation of the production process, following this guideline, our laser marking systems and machines pass through the required equipment qualification eq in 4 steps dq, iq, oq, pqmq. For more information on fda 21 cfr part 11 validation. Certified software quality assurance engineer experienced in new product development design controls for fda medical and commercial aircraft control systems using agile and waterfall techniques. Things to consider equipment design features installation and environmental conditions. Installation qualification iq for equipment and machines, as well as operational qualification oq and performance qualification pq for the manufacturing process.
The iq section establishes documented verification that key aspects of the computer adhere to approved design intentions and that the recommendations of the. The fda requires verification that equipment specifications have been met. A operational qualification oq is a testing protocol which provides documented evidence that the equipment has been properly challenged and documented. Mar 05, 2018 oq is operational qualification and pq is performance qualification. The pq qualification should be written in accordance with the validation plan. Writing effective iqoqpq protocols is a must for following the regulations required by. This protocol is executed during installation by qualified team, upon which an iq report is finally prepared with the deviations detected, if any. The procedure also includes example operational qualification oq and performance qualification pq protocols and control charts. When akaza implements its openclinica enterprise solution for a customer, we carry out the iq and oq testing, and provide the signed test. The procedure provides detailed instruction for tooling development and validation.
The completion of oq leads to performance qualification pq with oq successfully completed, you can move on to conduct pq the final stage in the validation process. By the end of iq, oq and pq the following should be answered. Apr 15, 2019 the completion of oq leads to performance qualification pq with oq successfully completed, you can move on to conduct pq the final stage in the validation process. It is usually performed after all other qualifications like dq iq oq pq. The vp is then used by the protocol writers as the official mandate for protocol. The fda defines iq as establishing confidence that process equipment and ancillary systems are compliant with appropriate codes and approved design intentions, and that manufacturers recommendations are suitably considered.
Shaila shaheed fda project manager, office of the chief scientist office of regulatory science and innovation baltimore, maryland area 167 connections. Operational qualification tests functional elements and insures that the system will meet all defined user requirements under all anticipated conditions of manufacturing, i. What is computer system validation and how do you do it. Writing compliant iqoqpq protocols meeting fda expectations. The operational qualification activity includes t he tests to be run in order to verify that the software is operationally fit to be deployed to the consumers. Using an iq oq pq approach to validating medical device software duration. Iq, oq, pq protocols are methods for demonstrating that equipment. Also sometimes called user acceptance testing uat, pq testing intends to demonstrate that an instrument consistently performs according to specifications. The pq describes the procedures for demonstrating that a system or piece of equipment. This is where the test scripts, identified above, are executed. In one case, we obtained approval from a client in february, specd out the equipment, received it in march, set it up and began manufacturing clinical trial batches and brought them to the clinical site by september 1st. This medical device software validation training will show how you can validate software using iq oq pq methodologies, typically employed for medical device process validation. Operational qualification oq and the performance qualification pq protocols. Page 2 guidance for industry and fda staff general principles of software validation in that case, the party with regulatory responsibility i.
The exact sequence followed can vary, but p1q is typically performed after successful installation qualification. A 5 day complete immersion in the validation process. The process of chamber qualification is identified in cfr 21 part 211, subpart c. Jul 16, 2018 writing effective iq oq pq protocols is a must for following the regulations required by the fda for equipment, systems, and utilities to demonstrate suitability for the intended use and to operate according to their design and functional specifications. Iq, oq, and pq constitute the 3qs of software validation process. All our three part combined iq oq pq protocols are written to a common standard with the layout, introduction and table of contents being very similar.
The operational qualification oq the performance qualification pq these qualification protocols are used to ensure that all necessary tests and checks are performed to verify that the hardware. A basic guide to iq, oq, pq in fdaregulated industries. It is interactive, easy to use and suitable for all mixes of equipment with and without software. The way we run the iq, oq, pq process really expedites the transfer of a product into our facility. These terms are not commonly used with software, but these processes can be successfully applied to software validation in order to reduce the likelihood of enduring a software recall. By now all the bugs should have been worked out during iq and oq so that the pq should hopefully proceed smoothly. Fda small business regulatory education for industry redi. Sop development and implementation, training, iq oq pq process, final validation reports, final fda 21 cfr part 11 validation approvals and maintenance and followup services.
When akaza implements its openclinica enterprise solution for a customer, we carry out the iq and oq testing, and provide the signed test scripts together with a detailed report on the setup and configuration of the software. This stage confirms that the software, as it was installed, will perform the way your company needs it to. Quality system regulation 21 cfr part 820 and iso 485. If you were to take those two products and examine them, there is no denying there would be a long list of properties that vary greatly between the two. Based on the processes and specifications outlined in the previous. General principles and practices on page 10 section c paragraph 2 states here. 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 oq functionality testing. Iq, oq and pq installation qualification iq shows that the system has been installed correctly.
853 88 1478 63 961 1408 847 778 1463 304 543 1449 468 781 1079 415 209 709 1054 1267 1105 1140 1072 1306 565 340 141 739 635 660 1136 327 599 1022 156 392 782