Archive for the ‘PRISYM ClinTrial’ Category

Jan 23rd

Posted in FDA, Industry News, Knowledge Base, Medical Labeling, PRISYM ClinTrial, PRISYM Medica

The ABC’s of IQ, OQ, and PQ?

LOL, and OMG….today everyone knows what these internet slang terms mean and how to use them.

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. For those who are new to the very specific world of Life Sciences, we’ll try to debunk the myths around some of the terminology.

So what is meant by IQ, OQ, and PQ? They are terms that fall under the category of validation and verification.

IQ stands for “Installation Qualification”. The IQ records the installation of the software, and ensures that the installation follows the correct steps.

OQ stands for “Operational Qualification”. The OQ tests or qualifies that the solution is working using test data in general. This maps across to the requirements stated in the Functional Specification, and ensures the product or application meets all the predetermined requirements as stated.

PQ stands for “Performance Qualification” which means that the application, under real life conditions, consistently produces products which meet all predetermined requirements. The PQ is the final test before production (potentially the most important test document you will ever run), testing that the solution works fully in the live environment using live data, and should be based back on a workflow model from your User Requirements Specification.

On top of the IQ/OQ/PQ, you should ensure that you have other key documents including The Validation Master. This will form the detail and coverage of the documentation that you need.

Last thought for the day is that validation requires documented evidence, if the validation process is not documented then it cannot be proven to have occurred. Put another way, your regulatory body will view your validation process as solely a ‘rumour’.

Dec 7th

Posted in FDA, Medical Labeling, PRISYM ClinTrial, PRISYM Medica

The Dreaded FDA Warning Letter – What it Means and What to Do

For those of you in the business of manufacturing medical devices or pharmaceuticals, you know all about the importance of following FDA regulations. If, after an FDA audit or inspection, you are found to be out of compliance, you could receive a Warning Letter or an Untitled Letter.

An Untitled Letter is basically a way of citing a violation that does not meet the threshold of regulatory significance for a Warning Letter. A Warning Letter is the most serious of FDA letters, but it’s important to note that it’s not a form of FDA enforcement action. Instead a Warning Letter is just as the name suggests – a ‘warning’ that, if certain corrections or changes are not made, the FDA could take further action.

The intention of the letters is to bring about voluntary compliance without committing the FDA to taking enforcement action. Although there is no immediate enforcement on the part of the FDA, they do expect recipients to make the necessary changes and voluntarily comply with the law. Since Warning Letters are made public under the Freedom of Information Act, it can be helpful to review warnings given to others in an effort to avoid making the same mistakes.

If you do receive a Warning Letter, there is normally a short window (typically 15 days) in which to issue a response to the FDA. The response should include:

1. the steps that have been or will be taken to correct the violations and prevent similar violations;
2. the timeframe within which the corrections will be completed;
3. any reason the corrective action has not been completed within the response time; and,
4. any documentation that shows that correction is complete.

The amount of change that needs to take place to ‘close out’ a warning varies depending upon the violation. If the Warning Letter is in reference to misleading promotional activities, it could be as simple as discontinuing the use of an ad campaign. If, on the other hand, the violation has to do with the manufacturing process of a drug or medical device, there could be a long list of corrective actions that need to be taken. And it may take some time to address them all. In these cases the FDA may decide to withhold certain types of approvals until the issues have been rectified.

Once the violations have been corrected, a Close-Out Letter is issued. This is the official acknowledgement from the FDA that the violations outlined in the Warning Letter no longer exist.

We’d like to hear about your experiences with FDA letters. Have you ever received a Warning Letter? How long did it take before the issue was ‘closed out’?

Feb 1st

Posted in Medical Labeling, PRISYM ClinTrial

PRISYM ClinTrial

PRISYM ClinTrial is an ‘add-on’ software module to PRISYM Medica labeling software that provides additional features for managing randomized medical studies labeling and records for Clinical Trials. It is ideal for securely and accurately managing data for clinical trials supplies and complete patient kits / patient packs labeling that is completed in most clinical research trials.

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