Book:LIMS Selection Guide for Manufacturing Quality Control/Choosing laboratory informatics software for your manufacturing lab/Implementation

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3.2 Implementation

If you've ever worked through a system implementation process with a vendor, it was hopefully a smooth process. However, there are plenty of horror stories out there, highlighting the need of the laboratory to discuss in detail how a potential vendor will handle installation, validation, and training for the informatics solution. Does the vendor truly understand the industry and your needs? Does the vendor assign a project manager who will work with you, from planning to go-live and beyond? Can they offer you references of other labs who have gone through implementation so you can compare notes with those labs? How much attention does the potential vendor give to related issues such as data integrity of migrated data? Do they have the means to properly handle your legacy data? And are they able to work with your schedule, even if it means implementing software at off-peak work hours?[1][2]

As you finally get down to the ultimate decision on which vendor to work with, you may wish to start setting up an implementation checklist as part of your early project planning. Do you receive a help desk account as part of the implementation process, and if so, what information is included? If not, you'll need to keep track of specific details such as business associate agreement (BAA), sales agreement, scope documents, welcome letters, documentation, and approved staff who can utilize the vendor's support. You'll likely need to share other configuration details with the vendor, including time zone requirements, DNS and URL requirements, up-time monitors, and administrative account requirements. Finally, you'll want to ensure you and the vendor are on the same page concerning any additional customization, integration, and system validation requirements, ensuring the roll-out period is pain-free and efficient.

3.2.1 Internal and external integrations

Manufacturing-based labs acquire data management software for many reasons, including improving accuracy, saving time, increasing productivity, and adding capabilities. One way of doing all of those activities is to integrate or interface the manufacturer's systems, databases, and instruments so that human error is greatly reduced or eliminated, workflows are automated and sped up, and each component's capabilities are brought into play in the most efficient and effective ways possible. In the world of manufacturing, choosing what gets integrated makes for a challenging decision, however, given the other systems that may be at work in the organization. Other systems that may used in the manufacturing enterprise include:

These systems all have their strengths within the manufacturing enterprise but typically lack functionality necessary for laboratory processes. Not all systems need to be integrated with a laboratory system like a LIMS, but some may benefit, for example with the MES and QMS.[3][4][5][6] As such, you'll want to inquire with the vendor about its solution's hardware and software integration capabilities. Is it designed to interface with every laboratory instrument or software that can output any readable electronic file? Or are integrations limited to certain instruments and systems? How does it connect, i.e., what protocols does the software depend on to connect with other systems? Does the system allow a user to map their own file imports and exports? Can system processes be set to detect new instances of file outputs at regular intervals? Ask these and other questions to make sure the vendor clearly describes what internal and external integrations are supported with their application.

In many cases, a vendor's LIMS solution will have instrument integration capability built into the software, but occasionally such interfaces are separate from the main software. Today's instrument interfaces are generally built on standardized communication protocols such as RS-232, RS-422, IEEE-488 (GPIB), USB, Ethernet, and more.[7] The LIMS that can support such instrument integrations is increasingly vital to the manufacturing-based laboratory. Manufacturing labs may also want their laboratory informatics solution to be able to communicate with other software and databases. This is often done using application programming interfaces (APIs) that depend on web services implementation protocols such as REST and SOAP.[8][9][10] These messaging protocols actually allow for the creation of an API that receives communication requests and sends responses between two software systems. A more practical example is wanting your laboratory informatics solution to communicate with an enterprise resource planning (ERP) application. Perhaps the ERP system needs to create sample batches within the informatics solution, and when testing is done, have the results returned to the ERP. APIs and communication protocols make this happen.[9]

References

  1. Wagner, M. (10 October 2019). "7 Software Implementation Challenges and How to Solve Them". WalkMe Blog. WalkMe Ltd. https://blog.walkme.com/7-software-implementation-challenges/. Retrieved 05 May 2023. 
  2. Mura, A. (12 July 2018). "Bullet-Proof Software Implementation Plan: Challenges and Tactics". Userlane Digital Adoption Blog. Userlane GmbH. Archived from the original on 18 April 2021. https://web.archive.org/web/20210418093657/https://www.userlane.com/software-implementation-plan/. Retrieved 05 May 2023. 
  3. Boyar, Kyle; Pham, Andrew; Swantek, Shannon; Ward, Gary; Herman, Gary (2021), Opie, Shaun R., ed., "Laboratory Information Management Systems (LIMS)" (in en), Cannabis Laboratory Fundamentals (Cham: Springer International Publishing): 131–151, doi:10.1007/978-3-030-62716-4_7, ISBN 978-3-030-62715-7, http://link.springer.com/10.1007/978-3-030-62716-4_7. Retrieved 2023-05-03 
  4. McDonald, J. (5 April 2023). "Key differences between MES and LIMS in battery QA". The Connected Lab. Thermo Fisher Scientific. https://www.thermofisher.com/blog/connectedlab/key-differences-between-mes-and-lims-in-battery-qa/. Retrieved 05 May 2023. 
  5. Becks, M.B. (2021). "Implementation of MES at Small EMS Providers". University of Twente. https://purl.utwente.nl/essays/87515. Retrieved 05 May 2023. 
  6. "Automate Production Even More: Laboratory Management Information Systems (LIMS) in Manufacturing Execution System (MES)". Soft Industry Blog. Soft Industry. 21 February 2023. https://soft-industry.com/blog/lims-in-mes/. 
  7. Williams, C.D.H.. "Computer Interfaces for Instrumentation Systems". University of Exeter. https://newton.ex.ac.uk/teaching/CDHW/Interfaces/. Retrieved 05 May 2023. 
  8. Monus, A. (17 October 2022). "SOAP vs REST vs JSON - a 2023 comparison". Raygun. https://raygun.com/blog/soap-vs-rest-vs-json/. Retrieved 05 May 2023. 
  9. 9.0 9.1 LabVantage Solutions (7 January 2018). "A Quick Guide to LIMS Web Services". LabVantage Solutions, Inc. https://www.labvantage.com/a-quick-guide-to-lims-web-services/. Retrieved 05 May 2023. 
  10. Grand, A.; Geda, E.; Mignone, A. et al. (2019). "One tool to find them all: A case of data integration and querying in a distributed LIMS platform". Database 2019: baz004. doi:10.1093/database/baz004.