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Autoscribe LIMS Blog - Regulatory

Regulatory

The Clock Ticks for US Food Testing Labs to be LAAF-Accredited

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

Picture of a document being signed. The final step of a formal transaction.

Regulatory

How LIMS Ensures FDA 21 CFR Part 11 Compliance

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.

15th January 2024

Regulatory

Drug Companies Cited Over Lack of Stability Testing

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

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