MENU

Leveraging LIMS to Achieve Regulatory Compliance for the Cannabis Testing Laboratory

C.E. Credits: P.A.C.E. CE Florida CE
Speaker

Abstract

Most Cannabis testing laboratories perform a variety of tests, full analysis for production QA/QC, and contract commercial testing, while others focus on extraction or purification only, or research. With the legalization of Cannabis in Canada, and growing acceptance in the US for medicinal as well as recreational use, testing is becoming a critical component in ensuring product quality.  ISO 17025 Certification is a requirement for Cannabis testing laboratories, along with many other state and federal requirements. Other organizations that are manufacturing products such as CBD or THC also need to understand and comply with Good Automated Manufacturing Practices (GAMP). In order to effectively manage the increasing volume of data and information, Laboratory Information Management Systems (LIMS) are a necessity. Beginning with sample accessioning and workflow management LIMS can manage system access along with analysts’ permissions and privileges. This is important, as regulated laboratories are required to provide evidence of the training and competence of the analysts that are performing the analysis for specific tests. Their training records and certifications must be provided and updated as required. The LIMS will track any changes to results in an audit trail, to ensure that the data has not been manipulated. Any changes to results (the majority will come directly from the instrument) will be documented – the system will hold the original result, the new result, the date and time stamps for each, along with the analyst information and a reason that the result was changed. This process provides a high level of data integrity. The LIMS can also “force” peer review. This means that the person that entered a result cannot be the person that validates and approves that result. Many of these LIMS features help to enforce regulatory compliance with ISO 17025 as well as other GALP (Good Automated Laboratory Practices) and GAMP requirements. There are so many functions that LIMS can manage and enhance over manual systems; many that are not directly associated with result data. These includes managing chemicals, supplies, and reagents (used in the testing), and their associated expiration dates, lot numbers, CoAs, safety sheets and along with vendor information. LIMS not only organize sample workflow (with positive ID) and result data (along with automated instrument data uploads), but also calculations that can be validated and locked. This presentation will also examine the growing use of sensors in the laboratory for temperature, humidity, light, etc. and will highlight the integration with the LIMS for meeting the requirement for daily temperature monitoring of the incubators, refrigerators, and freezers in the laboratory. Streamlining laboratory operations (instrument integration, calculations, temperature monitoring, automated alerts for out-of-specification products) and eliminating mundane tasks are critical to ensuring the production of high-quality data, improving productivity, maximizing resources, and increasing efficiency, thereby increasing profitability.

Learning Objectives:

1. Learning key LIMS functionality which can be expanded with automation

2. Understanding key ISO regulatory requirements that Cannabis laboratories face

3. Gaining insight into how automation and LIMS can help Cannabis laboratories to achieve compliance


Show Resources
You May Also Like
FEB 15, 2023 7:00 AM PST
FEB 15, 2023 7:00 AM PST
Date: February 15, 2023 Time: 7:00am (PST), 10:00pm (EST), 4:00pm (CET) While not all microscopy samples can fluoresce, all can scatter light, and this scattered light can be imaged. This ha...
AUG 24, 2022 7:00 AM PDT
AUG 24, 2022 7:00 AM PDT
Date: August 24, 2022 Time: 7:00am (PDT), 10:00pm (EDT), 4:00pm (CEST) Light field microscopy was first introduced in 2006, and allows users to capture the 4D light field within the microsco...
OCT 13, 2022 9:00 AM +08
OCT 13, 2022 9:00 AM +08
First Broadcast: Date: October 12, 2022 Time: 8:00am PDT, 11:00am EDT Second Broadcast: Date: October 12, 2022 Time: 9:00am SGT The new Embedded CryoSPARC Live, now fully integrated with t...
AUG 10, 2022 10:00 AM PDT
AUG 10, 2022 10:00 AM PDT
Date: August 10, 2022 Time: 10:00am PDT, 1:00pm EDT The global pandemic has increased focus and scrutiny on molecular diagnostic assay development, resulting in a need for assays that provid...
APR 05, 2023 11:00 AM NZST
C.E. CREDITS
APR 05, 2023 11:00 AM NZST
Date: April 05, 2023 Time: 11:00am (NZDT) Date: April 04, 2023 Time: 4:00pm (PST), 7:00pm (EST), 1:00pm (CET) Polymerase chain reaction (PCR) technology-based testing method has been widely...
SEP 28, 2022 9:00 AM PDT
SEP 28, 2022 9:00 AM PDT
Date: September 28, 2022 Time: 9:00am (PDT), 12:00pm (EDT), 6:00pm (CEST) While COVID-19 continues to be the most pressing diagnostic focus for clinical laboratories, HIV remains a serious g...
Loading Comments...
Show Resources