LES implementation readiness checklist
Would your laboratory benefit from electronic execution, or could the process introduce risks or compliance challenges into the workflow?
1) How homogenous is your lab?
a. My Lab(s) differ significantly according to equipment, product, and sterility level
b. My Lab(s) have/has lots of equipment or multiple sites but use fundamentally similar equipment types
c. My Lab is a single site or multiple sites with minimal lab equipment
2) How homogenous is your process?
a. My Labs have multiple international sites that have local variants of SOPs
b. My Labs have multiple sites, but all processes are harmonized
c. My lab is a single site with global SOPs
3) Do you have an existing change management process for modifying lab processes?
a. Yes. Between both local and global change management exists as well as communication channels between them.
b. A local change management system exists along with a system to bring global updates.
c. Change what?
4) How often do paper records get used during standard lab procedures?
a. Standard lab procedures are entirely stored as electronic records.
b. Paper-based SOPs and protocols are used for all/most procedures but other records are electronic.
c. Paper SOPs, Protocols, Lab notebooks, and sample management are all common in my lab.
5) How complex are your protocols?
a. Lab technicians have specialist training to conduct procedures and analyze outcome according to sample types, requiring many manual steps.
b. Samples can be products, standards, or quality controls, but all procedures have rigid protocols. Data collection steps are manual.
c. Most equipment only has a single protocol. Sample types are consistent and data collection and reporting are both electronic.
6) Does all your equipment contain electronic measurements?
a. Yes: all equipment has a digital readout and audit trail
b. No: all equipment has an audit trail, but not all equipment has a digital readout
c. No: For example, the technician might use glassware or pipettes, scales, or assays that must be visually read by the technician.
7) What is the level of IT infrastructure in your laboratories?
a. All the laboratories have high-speed internet, sufficient storage capacity, and available computer system can implement LES.
b. The laboratories have high-speed network but data storage capacity is low
c. The laboratories are working on paper-based system and do not have developed IT infrastructure
If you answered mostly ‘a’, your lab is well-positioned for LES implementation to have the best impact to simplify your lab processes and compliance.
If you answered mostly ‘a’ and ‘b’ you may have some minor harmonization or equipment considerations before implementing LES. Consider a risk analysis scoping to pre-emptively determine the compliance challenges.
 https://www.gxp-cc.com/insights/blog/anticipating-fda-initiatives-for-risk-management/, https://www.gxp-cc.com/insights/blog/quick-starter-controls-to-reduce-risks-on-industry-4-0-implementations/
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