Cannabis legalization in various US states has motivated the cannabis industry to ensure credibility and produce high-quality products for consumers. Cannabis testing labs also aim at clearing third-party audits and meeting regulatory requirements to assure product safety and quality. With increasing quality standards in the cannabis industry, testing labs focus on meeting regulatory compliance such as ISO 17025:2017, 21 CFR part 11, GLP, and state and local regulations. Moreover, increased attention from the US Food and Drug Administration (FDA) to safeguard public health is propelling the cannabis manufacturers and testing labs to follow the current Good Manufacturing Practices (cGMP).

Labs rely on data to monitor their performance and make decisions that help them meet the requirements of both consumers and regulators. However, labs face multiple daily challenges, data management challenges being one of the biggest ones. It is difficult to capture, analyze, and manage large volumes of data from multiple samples. For industries such as cannabis, making the maximum use of data becomes a differentiating factor for sustainable, long-term success. Cannabis companies can generate better outcomes and avoid nonconformance to regulatory requirements with the proactive use of cannabis data.

How to Make the Most Out of Your Lab Data

Leveraging the data correctly can help reduce human errors in cannabis labs and ensure improved data traceability and integrity. The following ways can help cannabis labs effectively leverage their data to overcome operational challenges:

1. Ensure Data Integrity for Decision-Making

Data-driven decisions in the cannabis industry help ensure the quality of the final products. Therefore, it is essential to maintain data integrity. According to the FDA, the data that is attributable, legible, contemporaneously recorded, original, and accurate (ALCOA), promises data integrity. Cannabis labs should maintain data integrity as they receive, store, process, and report data collected during cannabis testing. Labs can maintain data integrity by deploying systems that support data integrity.

2. Adopt Effective Measures to Minimize Data Variability

With large volumes of data generated daily, cannabis testing labs find it challenging to prevent data variability when testing the same samples. Sometimes, human errors lead to altered data which drives data variability. Lab instruments come from different manufacturers and have different calibration standards, adding to data variation. Furthermore, different labs use different methods for analytical testing, leading to inter-laboratory variation in test results. Standardization of testing protocols, effective data management strategies, implementation of a quality management system, and compliance with good laboratory practice (GLP), ISO/IEC 17025 can reduce data variability in cannabis testing labs to a great extent.

3. Leverage Data to Identify and Analyze Operational Issues

Nowadays, labs mostly rely on automation to standardize their lab workflows. Automation helps labs eliminate manual errors and data inconsistencies, increase testing throughput, and reduce the turnaround time. Automation provides complete data traceability and helps track samples at any point in the sample life cycle without manual intervention. Furthermore, automation flags out-of-specification results and enables lab managers to take further actions. Additionally, audit trails track all data changes, who made the changes, and when. This helps maintain data integrity, identify process irregularities, initiate necessary corrective actions, and is crucial for third-party audits.

4. Visualize Data to Improve Efficiency

Nowadays, labs can generate an abundance of data from a single sample. Data visualization tools can help them pick the most important data from the pile of collected data. Visualizing data using graphs and pie charts provides a good interpretation of data. It not only helps optimize the sample testing process at the lab but also helps the producers of cannabis products produce more diverse and customized products for consumers. Easy interpretation of analytical data helps in quick and effective decision-making.

How Can a Cannabis LIMS Drive the Right Use of Data in Cannabis Labs?

Nowadays, labs rely on data management tools to manage large volumes of data and maintain efficiency and quality in the regulatory process. Labs need to practice sensible use of data to monitor lab performance, reduce data variability, and automate lab testing. A Laboratory Information Management System (LIMS) is a perfect tool for labs to help them make accurate use of data and digitize operational workflows.

A Cannabis LIMS can help testing labs support data integrity concepts, track deviations from standard procedures, and centrally store data to make business and reporting decisions.

A LIMS helps cannabis testing labs in the following ways:

• Supports data integrity
• Reduces data errors & ensures high-quality data
• Minimizes data variability through process standardization
• Provides complete traceability through lab data
• Provides complete audit trail from sample accessioning to disposal, thus providing insights into the lab processes
• Enhances result accuracy & lab efficiency
• Generates graphs to visualize data
• Streamlines QA/QC processes
• Supports compliance with ISO/IEC 17025:2017, 21 CFR part 11, GLP, GMP, and other state and local regulations

Conclusion

Cannabis testing labs can proactively address their daily challenges by making the most out of their data. As the cannabis industry grows, it becomes essential for cannabis testing labs to have validated test methods, follow best practices, and comply with quality and safety standards. Sensible and digital data management can help labs meet demands both from consumers and regulators.

With a quality-centric approach, cannabis testing labs have started embracing the benefits of LIMS. A cannabis LIMS can help testing labs manage data better and guide them towards an easier path to compliance.

An internal audit is a kind of self-assessment conducted to identify critical issues and helps determine the effectiveness of a laboratory’s risk management capabilities. Internal audits provide insights into a laboratory’s culture, operations, and compliance with applicable laws and regulations. The data is precisely analyzed in internal audits to provide recommendations for improvement.

It is essential to conduct an internal audit if your laboratory is preparing for a third-party audit. An internal audit is instrumental in identifying operational gaps, thereby minimizing the chances of failure. An internal audit provides you an opportunity to check audit preparations before an external assessor arrives at your facility. An internal auditor, or an auditing team, should conduct an audit impartially, keeping in mind the requirements of an external audit. Conducting an internal audit also makes laboratory managers more mindful of the loopholes that an external auditor may identify, enabling laboratories to work on the areas of improvement.

Few benefits of internal audits for cannabis and hemp testing laboratories are as follows:

• Ensure compliance with industry standards, statutory and regulatory requirements, such as ISO 17025:2017, 21 CFR part 11, GLP, and state and local regulations.
• Prevent expensive mistakes and improve operational efficiency.
• Determine if the QA/QC processes implemented are effective in generating accurate and repeatable results.
• Be better prepared to answer the questions of external auditors and face them with confidence.
• Determine the effectiveness of the quality management system in place.
• Determine if laboratory staff members follow pre-defined standard operating procedures (SOPs).

An internal audit is typically done under a CAPA (Corrective and Preventive Actions) program. CAPA is a part of the quality management system which controls and detects errors in laboratory processes so that corrective measures can be taken to prevent their recurrence. The CAPA program enables you to thoroughly investigate and determine the root cause of potential issues. It allows you to record customer complaints and aids in continuous improvement. An effective CAPA program enables laboratories to pinpoint the factors responsible for cross-contamination, such as improper environmental controls, poorly designed laboratory infrastructure. High-quality laboratory supplies are imperative for generating accurate test results. A CAPA program enables cannabis testing laboratories to monitor the performance of suppliers to determine if they are consistently meeting the specified requirements. Ideally, cannabis testing laboratories should procure supplies from vendors certified to specific standards.

Role of a Cannabis LIMS in Internal Audits

A LIMS for cannabis and hemp testing helps ensure data accuracy and integrity, compliance with regulatory requirements, efficient data management and analysis, and risk management. These benefits can help internal auditors perform their audits effectively and efficiently, and identify areas where improvements may be needed. A laboratory information management system (LIMS) facilitates not only external audits but also internal audits. A LIMS maintains a read-only audit trail to track all laboratory activities along with a date and time stamp and other details, such as who made the change, the reason for making the change. A LIMS maintains ongoing training and competency records of analysts and helps assign analytical tasks only to the competent staff, assuring the accuracy of test results. A LIMS enables cannabis testing laboratories to record customers’ complaints and corrective and preventive actions taken for non-conforming activities. A LIMS automates enforcement of SOPs, maintains a decisive chain-of-custody to track sample custodians through the sample lifecycle, and manages suppliers and laboratory inventory. A LIMS manages all internal and external documents such as validated standard test methods, drawings, manuals and ensures version control. A Cannabis LIMS ensures timely calibration and maintenance of instruments, records calibration results, and flags instruments that are unsuitable for analysis. Furthermore, a LIMS automates laboratory processes to reduce human errors and flags samples that fail testing.

Conclusion

Cannabis testing laboratories should plan and conduct internal audits from time to time to identify potential drawbacks in their operational workflows. Internal audits are time-consuming and resource-intensive, however; they offer innumerable benefits. A successful internal audit ensures standardization of processes and increases the chances of surviving external audits. To prepare your cannabis testing laboratory for an external or third-party audit, you should prepare an audit checklist and conduct an internal audit to understand if there are any gaps between your current processes and the requirements of the standard, such as ISO/IEC 17025:2017. Cannabis testing laboratories should implement automated systems, such as a LIMS, to digitally manage samples, test results, SOPs, staff training records, certificates of analysis (CoAs) and increase operational transparency. A Cannabis LIMS saves significant time and minimizes transcription errors. A successful audit calls for effective preparation, a good quality management system, trained laboratory personnel, and foolproof processes.