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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: To be determined

To be written...

The table of contents for LIMS Selection Guide for Manufacturing Quality Control is as follows:

1. Introduction to manufacturing laboratories

1.1 Manufacturing labs, then and now

1.2 Laboratory roles and testing in the industry

1.2.1 R&D roles and testing

1.2.2 Pre-manufacturing and manufacturing roles and testing

1.2.3 Post-production regulation and security roles and testing

1.2.4 Tangential laboratory work

1.3 Safety and quality in manufacturing industries

2. Standards and regulations affecting manufacturing labs

2.1 Globally recognized manufacturing standards

2.1.1 Food and beverage

2.1.1 British Retail Consortium (BRC) Global Standard for Food Safety (GSFS)

2.1.2 Codex Alimentarius

2.1.3 Global Food Safety Initiative (GFSI)

2.1.4 Hazard analysis and critical control points (HACCP)

2.1.5 International Featured Standards (IFS)

2.1.6 International Organization for Standardization (ISO) 22000

2.1.7 Safe Quality Food (SQF) Program

2.1.2 Materials

2.1.3 Pharmaceutical and medical devices

2.1.4 Other industries

2.2 Regulations and laws around the world

2.2.1 Food and beverage

2.2.2 Materials

2.2.3 Pharmaceutical and medical devices

2.3.4 Other industries

2.3 Other influencing factors

2.3.1 Good manufacturing practice (GMP) and current good manufacturing practice (cGMP)

2.3.2 Standards and Scientific Advice on Food and Nutrition (SSA)

3. Choosing laboratory informatics software for your manufacturing lab

3.1 Evaluation and selection

3.1.1 Technology considerations

3.1.1.1 Laboratory informatics options

3.1.2 Features and functions

3.1.2.1 Base features

3.1.2.2 Specialty features

3.1.3 Cybersecurity considerations

3.1.4 Regulatory compliance considerations

3.1.5 System flexibility

3.1.6 Cost considerations

3.2 Implementation

3.2.1 Internal and external integrations

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

4.3.1 Trade organizations

4.3.2 Conferences and trade shows

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

5.3.1 The value of demonstrations

5.4 Finalize the requirements specification and choose a vendor

6. Closing remarks

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