The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory.
The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the data compliance issues that have plagued the laboratories are relevant to areas such as manufacturing.
The message is to take the lessons learned from improving Data Integrity compliance from the laboratory setting and proactively apply the learnings to those “Beyond the Laboratory” areas. For example, the 21 CFR Part 11 requirements and ALCOA principles should be applied to all computerized systems even if they are not in a laboratory setting. It is recognized that modern manufacturing systems are heavily computerized, capturing huge volumes of data and often maintaining detailed audit trails and such the requirements of system access controls and source record lifecycle management apply.
Please find below a link to the complete article:
If you have any questions in relation to Data Integrity within or outside of the laboratory, including the benefits of taking a proactive approach please contact James Davidson, Ph.D. at firstname.lastname@example.org