Tag Archives: 21 CFR Part 11

Raw Data Management – Challenges for the Pharmaceutical Industry

arivis and BioMedion focus on developing software for the pharmaceutical industry. One of our areas of core competence is realizing Enterprise Content Management projects for managing raw data, especially device data in a GxP environment.

Our customers are confronted with a raft of challenges when it comes to managing their device data. Many laboratory systems do not meet the requirements of 21 CFR Part 11 (despite labels which often make claims to the contrary). They have considerable shortcomings in terms of user management, audit trails and protecting generated data against unauthorized modification. In addition, there is often no robust strategy that makes it possible to restore data that has been archived for many years.

Regulatory requirements are also becoming more onerous. In the latest Guidance for Industry “Data Integrity and Compliance with CGMP”, the FDA makes it unmistakably clear that the hitherto available option of declaring laboratory data in printed form as raw data is no longer valid in the field of complex systems (see also http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm495891.pdf, especially III.10).

Inspections are therefore increasingly focusing on computerized systems. This impact is reflected in current warning letters:


BBT Biotech GmbH          http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm502347.htm

Chongqing Lummy Pharmaceutical Co., Ltd. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm508291.htm

Sandoz International GmbH http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm474013.htm

We deal with all the questions thrown up by this guideline and the warning letters. How can device data be rationally archived, indexed and reprocessed? How can the reason for modifying data be logged even in systems that do not actually support this function? How can an audit trail be represented, even for laboratory equipment that was not specially developed for the pharmaceutical industry? How can proprietary manufacturer-specific files be read and made sense of many years in the future if the laboratory application that was originally used is no longer available?

During the webinar we aim to examine the practical consequences of the requirements defined in the latest draft of the above-mentioned FDA Guideline and to present BM-windream as a possible solution to the problems outlined above.