Book:LIMSpec 2022 R2

LIMSpec 2022 R2

Title: LIMSpec 2022 R2

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: December 2022

Many specification documents for laboratory informatics systems have been compiled over the years. Most of them tend to focus on a potential client's "wishlist" of features for a given system. This updated version of a revised LIMSpec is different; it attempts to take a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems. The specification is built out upon on more than 100 resources, with ASTM E1578-18 Standard Guide for Laboratory Informatics and its requirements list chief among them. After the introduction and methodology, various requirements are organized and listed in a methodical order, each supported by one or more regulations, standards, guidance, or accreditation requirements documents. Finally, LIMSpec 2022 closes with a few tips on putting the specification to use.

The December 2022 update focuses on the food and beverage industry, adding almost 30 new resources. Examples of significant additions include BRC Global Standards' Global Standard for Food Safety, Issue 8, Global Food Safety Initiative's Benchmarking Requirements Version 2020.1, and various other 21 CFR parts. Some verbiage on existing requirements was also slightly tweaked where necessary.

The table of contents is as follows:

1. Introduction

Introduction and methodology

2. Primary Laboratory Workflow

1. Sample and experiment registration

2. Sample management

3. Core laboratory testing and experiments

4. Results review and verification

5. Sample, experiment, and study approval and verification

6. Reporting

3. Maintaining Laboratory Workflow and Operations

7. Document and records management

8. Resource management

9. Compliance management

10. Instrument and equipment management

11. Batch and lot management

12. Scheduled event management

13. Instrument data capture and control

14. Standard and reagent management

15. Inventory management

16. Investigation and quality management

4. Specialty Laboratory Functions

17. Production management

18. Statistical trending and control charts

19. Agriculture and food data management

20. Environmental data management

21. Forensic case and data management

22. Clinical and public health data management

23. Veterinary data management

24. Scientific data management

25. Health information technology

5. Technology and Performance Improvements

26. Instrument data systems functions

27. Systems integration

28. Laboratory scheduling and capacity planning

29. Lean laboratory and continuous improvement

30. Artificial intelligence and smart systems

6. Security and Integrity of Systems and Operations

31. Data integrity

32. Configuration management

33. System validation and commission

34. System administration

35. Cybersecurity

36. Information privacy

7. Closing remarks

Putting LIMSpec to use