All articles filed under:
Regulatory
FDA warning letters continue to highlight the issue of ensuring data integrity within laboratories. How are you ensuring data is not changed (deliberately or otherwise) and is stored securely? This article discusses the issue and one way of managing it to meet the stringent requirements of regulated laboratories.
10th June 2024
Regulatory
Regulated laboratories need to ensure electronic records and electronic signatures can be relied upon in the same way as paper records and hand written signatures. Using a LIMS helps enforce signature policies to meet FDA 21 CFR Part 11.
24th April 2024
Regulatory
FDA is gradually tightening the rules on food testing labs to mandate that, under certain circumstances, food testing must be performed only by LAAF-accredited laboratories. This article discusses how this affects contract testing labs and how the can comply with the amendments to Food Safety Modernization Act.
13th March 2024
Regulatory
The US FDA provides a comprehensive public record of the citations and warning letters [1] issued to Pharmaceutical Companies. This provides an excellent resource for those looking for guidance to improve quality and mitigate risk.
8th October 2020
Regulatory
11th June 2018
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