In 2017, data integrity issues were cited in 65% of all FDA warning letters. The main reason was incomplete data. In the Pharma and Biotech Industries this can be prevented by ensuring the trustworthiness and reliability of electronic records, a process that is also known as Compliance with Data Integrity. The highest risks, when not working in a compliant manner, lie in import bans, product re-calls or even the closing of production plants.

 

 

The US FDA and European Commission have defined the criteria for ensuring trustworthy and reliable electronic records and electronic signatures in computerized systems of regulated pharmaceutical industries. Regulations and standards such as FDA (21 CFR Part 11), EU (Annex 11), GMP, and ISO (ISO 17025) have recognized both the advantages and limits of electronic data systems and have increasingly established further controls for the use of such systems all the way down to bench top instruments. The goals of reducing errors, simplifying processes, and reinforcing compliance can be enabled by compliance with 21 CFR 11/Annex 11 and Computer Systems Validation. 

 

 

Osmolality testing is a valuable parameter for process control and final QC—giving you increased confidence in your products. Designed specifically to fit your Pharma and Biotech compliance needs, the OsmoTECH® PRO Multi-Sample Micro-Osmometer from Advanced Instruments Osmometers support Data Integrity Compliance by delivering the highest level of data management, accuracy and precision, and ease-of-use available on the market today. They provide valuable concentration measurements while delivering unsurpassed data management capabilities, operational efficiency, ease of use, and features that support GMP, 21 CFR Part 11, and EU Annex 11 compliance.

 

Attendees will Learn the Following During this Presentation: