Book:LIMS Selection Guide for Manufacturing Quality Control

Title: LIMS Selection Guide for Manufacturing Quality Control

Edition: First Edition

Author for citation: Shawn E. Douglas

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: May 2023

Manufacturing endeavors and quality control have a long yet twisted history together, with standards, guidelines, best practices, and regulations all shaping how the two relate to each other. Consumer safety and higher quality weren't always goals of manufacturers, but today they are vital considerations towards the final end product during a time when a single product failure could ruin a manufacturer already competing in a highly competitive environment. Maintaining compliance with standards and regulations that guide safety and quality now requires more than paper notebooks and spreadsheets, particularly when it comes to laboratory analyses associated with that compliance. Manufacturing-based laboratories are continuing to adopt information management strategies that welcome solutions such as the laboratory information management system (LIMS) into the workflow of the manufacturer and its associated labs. However, selecting the right LIMS or other informatics solution is not a straightforward task.

This guide broadly examines the field of manufacturing across a variety of associated industries, discussing the evolution of the manufacturing-based lab and the activities it undertakes in the pursuit of safer, higher-quality products. It will look at examples of standards and regulations that impact these labs and how laboratory informatics solutions can best be utilized to maintain compliance with those standards and regulations. It will give acquisition advice and considerations while also providing a useful user requirements document in the form of LIMSpec. By the end, the reader should have a clearer idea of the challenges that affect manufacturing-based labs and how properly acquired and implemented software solutions, like the LIMS, can have a positive impact.

(NOTE: The PDF output of this guide fails to properly list the references. To see the original document, with references, see here.)

About this book

Introduction

1. Introduction to manufacturing laboratories

1.1 Manufacturing labs, then and now

1.2 Laboratory roles and activities in the industry

1.3 Safety and quality in manufacturing industries

2. Standards and regulations affecting manufacturing labs

2.1 Globally recognized manufacturing standards

2.2 Regulations and laws around the world

3. Choosing laboratory informatics software for your manufacturing lab

3.1 Evaluation and selection

3.2 Implementation

3.3 MSW, updates, and other contracted services

3.4 How a user requirements specification fits into the entire process (LIMSpec)

4. Resources for selecting and implementing informatics solutions

4.1 LIMS vendors

4.2 Consultants

4.3 Professional

4.4 LIMSpec

5. Taking the next step

5.1 Conduct initial research into a specification document tailored to your lab's needs

5.2 Issue some of the specification as part of a request for information (RFI)

5.3 Respond to or open dialogue with vendors

5.4 Finalize the requirements specification and choose a vendor

6. Closing remarks

6.1 Closing remarks

7. Appendix 1. Blank LIMSpec template for manufacturing labs

A1. Introduction and methodology

A2. Primary laboratory workflow

A3. Maintaining laboratory workflow and operations

A4. Specialty laboratory functions

A5. Technology and performance improvements

A6. Security and integrity of systems and operations

A7. Putting those requirements to practical use and caveats

A8. LIMSpec in Microsoft Word format