Laboratories of regulated industries like BioPharma, Medical Device or Cosmetics need to focus on regulatory compliance in most aspects of their operations. With an increased number of Form 483s issued in 2019 the main observation citation was “Procedures applicable to the quality unit shall be in writing and shall be followed”. But compliance-related activities are time-consuming and considered non-value adding activities—generating costs and delaying product releases. Meanwhile non-compliance can lead to product halts, recalls, fines and damage the brand reputation.

Organizations must therefore investigate smart ways to minimize Compliance Risk

The solution to minimize compliance efforts and risks at the same time is to maximize automation in the laboratory. This can be achieved through integration and standardization, leading to higher lab efficiency and productivity, reductions in errors and compliance efforts, and reduced costs and waste.

While the main FDA observations were around procedures, the good news is that they are an easy target for improvement by automation as the execution of procedures includes a significant amount of routine tasks. Lab technicians use procedures that they follow and document step-by-step, and then the data will be reviewed, and Certificates of Analysis issued for batch release.

Procedure Management  solution to reduces Compliance Risk

An advanced standards-based Procedure Management solution allows the users to easily follow procedures in the
lab without the need for paper copies. It also enforces a step-by-step execution and allows for automated data transfer from the instruments, as well as an easy recording of data and observations on-site and meta-data extraction. Additionally, it provides an automated review and approval process, including review-by-exception and deviation warnings.

These capabilities allow lab organizations to work more efficiently, ensure data integrity and quality and effortlessly achieve Operational and Compliance Excellence.

BIOVIA WHITE PAPER : PROCEDURE MANAGEMENT SOLUTION SIGNIFICANTLY REDUCES COMPLIANCE RISK

Biovia is a gold sponsor, exhibitor at the Paperless Lab Academy 2020 and will also run a workshop  >> see about Why Digitalize my QC Lab when it’s already electronic?

Dassault Systèmes, the 3DEXPERIENCE Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systèmes’ collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 220, 000 customers of all sizes, in all industries, in more than 140 countries.

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