Novinity Software recently released its Version 3.0 PAT toolkit. The software was designed specifically to implement the FDA’s Process Analytical Technology initiative in the pharmaceutical manufacturing process. The company’s third version builds on the software’s data trending and analyzing features for process development.
PAT toolkit was originally built over eight years ago for use in radiopharmaceutical production. The software allows manufacturers to observe their production processes as they occur and avoid potential problems before they happen. A trademark of the software is its ability to easily connect with industry standard equipment and existing platforms, including on-line technology such as near infrared spectroscopy (NIR).
In commenting about the software’s third release, Novinity’s CEO Lance Tinseth said, “A consistent problem for our clients is the ongoing challenge of using different vendors’ solutions and somehow making them connect and talk back and forth. Coupled with this headache is the challenge of trying to make sense of the manufacturing data as it is happening. Added to this is the tedious task of spending days or weeks approving the compiled paperwork. We’re excited to offer PAT toolkit as a solution to these problems by providing a way to unite all this information together, regardless of the piece of equipment that produced it. By doing this in near real-time, clients have a snapshot of the manufacturing process as it is occurring. This empowers pharmaceutical manufacturers to make better decisions, faster.”
PAT toolkit is also capable of leveraging multivariate analysis (MVA) tools, to better predict product quality. In addition, third-party graphing and statistical analysis software can also be utilized to create PDF reports for process analysis. All this is done in a 21 CFR Part 11 compliant manner. The software can be easily validated in a modular fashion with attention paid to only those areas changed via audit log or designated as a change control required component.
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