Iq oq pq software

Our Clients. Contact Us. When performing IQ, a few key points to keep in mind include: Equipment design features i. Calibration, preventative maintenance, cleaning schedules Safety features Supplier documentation, prints, drawings and manuals Software documentation Spare parts list Environmental conditions such as clean room requirements, temperature, humidity Operational qualification OQ : Performed to ensure that process control limits and action levels which result in the product meets all predetermined requirements.

When performing OQ, a few key considerations include: Process control limits time, temperature, pressure, line speed, setup conditions, etc. Software parameters Raw material specifications Process operating procedures Material handling requirements Process change control Training Short term stability and capability of the process, latitude studies or control charts Potential failure modes, action levels and worst-case conditions Failure Mode and Effects Analysis, Fault Tree Analysis Use of statistically-valid techniques such as screening experiments to establish key process parameters and statistically-designed experiments to optimise the manufacturing process Performance qualification PQ : Performed to ensure that all processes, under anticipated conditions, consistently produce a product which meets all predetermined requirements.

When performing PQ, a few key items to ensure include: Actual product and process parameters and procedures established in OQ Acceptability of the product Assurance of process capability as established in OQ Process repeatability, long term process stability Conducting PQ would require you to run the relevant processes a few times to collect the relevant objective evidence.

Older Post Definition: Software Validation. Have any questions? Thank you for your question. There are applications that can be used to electronically execute test scripts e. If you are asking about something else, please let us know. Thanks for sharing this information. I would like to ask about the manufacturer software validation MSV , is it something can replace the PQ? Great question. As an end-user of any software in a GxP regulated environment, you are required to show evidence that the system is fit for purpose based on your intended use, and regulatory requirements.

Therefore, you need to be aware of that schedule so you can make sure they are doing their functional testing OQ for the update, and you can do any necessary requirements testing PQ. I am having difficulty organizing my PQ test scripts. What perspective should the scripts be written from and how detailed do the test scripts need to be? The primary purpose of PQ test scripts is to verify your user requirements how the system is expected to work based on your internal processes and procedures.

They should follow a typical end-to-end process or day-in-the-life perspective of using the system. The level of detail in PQ scripts should be based on how experienced your testers are with the system and the processes. Use pre-requisite sections to identify master data that needs to be set up or configured to execute the steps. Your email address will not be published. This site uses Akismet to reduce spam. Learn how your comment data is processed. CSols Inc.

Share Now:. Categories: Validation. August 8, at pm. Verification of equipment specifications is required by the FDA and is especially important in highly-regulated industries such as the production of pharmaceuticals and medical devices. IQ is important as the performance of the equipment will depend on how it is installed.

Depending on the equipment in question, specifications to be inspected may include materials, dimensions, working temperatures and pressures, volume, flow rate, and torque. There will also be checks to ensure that the equipment is not damaged and that it has been installed in the appropriate location and correctly connected with other pieces of equipment, where applicable. From a facility standpoint, the IQ process might include ensuring the equipment has ample bench or floor space and checking it has the proper utilities supply.

If the equipment is moved or modified, or undergoes major maintenance, it must be re-qualified. In addition, ongoing IQ can be built into routine QA protocols.

The main goal here is to determine that the equipment performs as expected. During OQ, equipment features are tested separately to ensure that they meet the operating ranges specified by the manufacturer. In particular, OQ looks at any features that could have an impact on the quality of the final product.