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2. List of electronic laboratory notebook software packages

   en.wikipedia.org/wiki/List_of_electronic...

   21 CFR Part 11 Compliance Information IGOR - Your Personal Lab Assistant: Wildfell Software LLC 2020 United States: 21 CFR Part 11 Labguru: Biodata Ltd [5] 2011 [5] United States: 21 CFR Part 11 CellPort: CellPort Software, LLC: 2021 United States: 21 CFR Part 11 Genemod [6] Genemod, Inc. 2018 United States: 21 CFR Part 11 Chemia ELN ...

3. Title 21 CFR Part 11 - Wikipedia

   en.wikipedia.org/wiki/Title_21_CFR_Part_11

   Many software and instrumentation vendors released Part 11 "compliant" updates that were either incomplete or insufficient to fully comply with the rule. Complaints about the wasting of critical resources, non-value added aspects, in addition to confusion within the drug, medical device, biotech/biologic and other industries about the true ...

4. Electronic trial master file - Wikipedia

   en.wikipedia.org/wiki/Electronic_trial_master_file

   An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.

5. Electronic lab notebook - Wikipedia

   en.wikipedia.org/wiki/Electronic_lab_notebook

   Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) [8] and Title 21 CFR Part 11. [9] Essentially, the requirements are that the software has been designed and implemented to be suitable for its intended purposes.

6. Dionex - Wikipedia

   en.wikipedia.org/wiki/Dionex

   Dionex developed the Chromeleon brand of chromatography software. The primary function of Chromeleon is to control and obtain data from analytical instruments, such as GC, LC, IEX and MS. Chromeleon is fully Title 21 CFR Part 11 compliant. Chromeleon 7.3 is the latest edition of the software. [6]

7. Laboratory information management system - Wikipedia

   en.wikipedia.org/wiki/Laboratory_information...

   A LIMS covers standards such as 21 CFR Part 11 from the Food and Drug Administration (United States), ISO/IEC 17025, ISO 15189, ISO 20387, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), FDA Food Safety Modernization Act (FSMA), HACCP, and ISBER Best Practices.