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Additional LIMS functionality requirements for cannabis testing

The average all-purpose LIMS will have a wide array of functionality. However, such a LIMS developed with quality in mind will take into account additional factors, such as the requirements current regulatory schemes, industry standards, and organizational guidelines place on the development of a LIMS. This development can be built around a strong specification based on those regulations, standards, and guidelines, a specification such as LIMSpec. Such a specification ideally addresses system requirements involving aspects including but not limited to sample management, reporting, resource management, quality control, system and instrument integration, data integrity, and cybersecurity.

But what about the special requirements of a cannabis testing laboratory? How does a specification document like LIMSpec—and by extension, a LIMS—address those laboratory needs?

The following examines the special requirements of cannabis testing and how a LIMS can address them. In particular, those requirements are matched to existing requirements in the original base LIMSpec specification document. Additional background is also provides. In a few rare cases, a LIMSpec requirement may not have a specific regulation, standard, or guidance document matched to it. These represent areas where regulatory bodies and standards agencies may need to address a gap in the future.

Sample registration

Requirement: The system should provide sample registration screens optimized for the cannabis testing industry, including the ability to differentiate among medical marijuana, recreational marijuana, and hemp, as well as derivative products and their various substrates.

Relevant LIMSpec:

• 1.11 The system should support the creation of user-definable default sample registration input screens and/or preferences.

Additional background: Even though some LIMS already provide the ability for users to define their own sample registration screens and fields, it doesn't necessarily mean the vendor will also include pre-loaded screens and preferences for a specific industry or scientific discipline. Those vendors tailoring sample registration screens and preferences specifically to cannabis testing lab requirements for launch-day deployment have a step up on other LIMS vendors. Also, sample registration should also support both remote sampling and in-lab sampling activities.

Pre-loaded cannabis testing protocols, labels, and reports

Requirement: The system should offer pre-loaded compliant cannabis testing protocols, labels, and reports that are optimized to and readily adjustable for a rapidly changing industry.

Relevant LIMSpec:

• 1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
• 1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
• 6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
• 6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.
• 6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.
• 6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.

Additional background: As with sample registration, end users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates. This includes the ability to customize certificates of analysis (COAs) for multiple testing scenarios like batch testing and batch-by-batch variance analysis.

A vital component of the testing protocols that should not be overlooked is how flexible their test parameter/specification limit sets are. As regulations and standards concerning cannabis testing—across many different substrates—may change rapidly at the federal, state, and local level, adjustments to the limits set within testing protocols must be easy to make. Additionally, the system should be capable of retaining older historic limit sets, such that past results can later be accurately linked to their original limit sets.

Creation and management of additional protocols, labels, and reports

Requirement: The system should provide users the tools for creating new, compliant test protocols, labels, and reports, as well as managing them as the industry changes.

Relevant LIMSpec:

• 1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
• 1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
• 6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.

Additional background: As with pre-loaded protocols, labels, and reports, providing users the ability to create and manage their own protocols, labels, and reports as the industry changes is vital. Similarly, the same need for a flexible yet robust means of adjusting limit sets—and preserving older ones—is also required.

Third-party system integration

Requirement: a web API to integrate with state-required compliance reporting systems Requirement: a means of manually or automatically integrating with seed-to-sale software

Relevant LIMSpec:

• 27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.
• 27.6 The system should be able to interface directly with a third-party reporting tool.
• 27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.

Additional background:

Instrument integration

Requirement: provide robust support for accurately and securely integrating with and collecting data from numerous types of scientific instruments

Relevant LIMSpec:

• 26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.
• 26.2 The system should be capable of sending samples and test orders to instrument data systems.
• 26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
• 26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.

Additional background:

Granular chain-of-custody

Requirement: chain-of-custody (CoC) tracking, down to a granular location level (e.g., Storage Room 2, Freezer 1, 3rd Shelf), and at every step (including package reception/sending), including subsamples and aliquots

Relevant LIMSpec:

• 1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
• 1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.
• 1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.
• 1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.
• 15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.

Additional background:

Inventory reconciliation

Requirement: support for inventory reconciliation, including sample weight reconciliation (automatically deducts sample and inventory quantities when consumed in tests), while limiting data entry errors (e.g., "pulling too much weight out of a source tag creating a negative quantity package") https://www.rockymountaincannabisconsulting.com/cannabis-business-blog/2020/5/14/avoid-infractions-top-5-metrc-cultivation-violations

Relevant LIMSpec:

• 1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
• 1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
• 2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.
• 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
• 15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples.
• 15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.

Additional background:

Real-time alerts

Requirement: support for real-time alerts of OOS results, so immediate action can be taken, if required (e.g., to identify health risks and pull the product if necessary)

Relevant LIMSpec:

• 3.12 The system should effectively alert users upon entry of out-of-specification test results.
• 16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.

Additional background:

Flexible specification limit sets

Requirement: support for the development of flexible and robust limit sets for various state and local regulations, as well as substrate requirements

Relevant LIMSpec:

• * 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.

Additional background:

Data security and confidentiality

Requirement: ensure data security and confidentiality for at-rest and in-transit data

Relevant LIMSpec:

• 35.1 The system should use secure communication protocols like SSL/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.
• 35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.

Additional background:

Accounting and billing

Requirement: support for accounting and billing functionality

Relevant LIMSpec:

• Currently no regulatory- or standard-based requirement for this, and thus not in LIMSpec.

Additional background:

Secure web portal

Requirement: provide a secure web portal for results review and test ordering

Relevant LIMSpec:

• Currently no regulatory- or standard-based requirement for this, and thus not in LIMSpec.

Additional background:

ISO/IEC 17025 compliance support

Requirement: support a laboratory's ISO/IEC 17025 compliance efforts (provides traceable documentary evidence required by 17025) https://www.imsm.com/us/news/how-can-a-cannabis-testing-lab-pass-iso-17025/

Relevant LIMSpec:

• 1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
• 2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
• 4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
• 6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
• 6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.
• 7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.
• 7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.
• 7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.
• 7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
• 7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.
• 7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
• 8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
• 10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years.
• 10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
• 10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
• 10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
• 10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
• 10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.
• 16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
• 27.3 The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.
• 27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
• 27.11 The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.
• 30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.
• 30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.
• 31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.
• 32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.
• 33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.
• 33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.
• 34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)

Additional background:

NELAC, ORELAP, and ELAP compliance support

Requirement: support a laboratory's NELAC or ORELAP compliance efforts https://cannabisindustryjournal.com/column/quality-plans-for-lab-services-managing-risks-as-a-grower-processor-or-dispensary/ and https://www.oregon.gov/oha/ph/LaboratoryServices/EnvironmentalLaboratoryAccreditation/Pages/Cannabis-accreditation.aspx Requirement: support a laboratory's ELAP compliance efforts https://www.wadsworth.org/regulatory/elap and https://www.wadsworth.org/regulatory/elap/medical-marijuana

Relevant LIMSpec:

• 2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
• 7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.
• 7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.
• 7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
• 7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.
• 7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
• 16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
• 16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.

Additional background: - quality manual, laboratorian credentials and experience, corrective and preventative action, proficiency testing, etc (https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf)

Volume 1, "Management and Technical Requirements for Laboratories Performing Environmental Analysis," of the NELAC Institute, National Environmental Laboratory Accreditation Program (TNI NELAP) https://casetext.com/regulation/florida-administrative-code/department-64-department-of-health/division-64e-division-of-environmental-health/chapter-64e-1-certification-of-environmental-testing-laboratories/section-64e-10015-laboratory-certification-standards

• EL-V1M1-2016-Rev2.1 Module 1, "Proficiency Testing"
• EL-V1M2-ISO-2016-Rev2.1 Module 2 "Quality Systems General Requirements"
• EL-V1M4-2017-Rev2.2 Module 4, "Quality Systems for Chemical Testing"
• EL-V1M5-2016-Rev2.0 Module 5, "Quality Systems for Microbiological Testing"

Patient Focused Certification (PFC) compliance support

Requirement: support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts https://safeaccess2.org/patientfocusedcertification/business-services/ and https://www.a2la.org/accreditation/cannabis-testing

Relevant LIMSpec:

• Unknown; unable to get document

Additional background: - R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program may have clues. However, A2LA will "only give that document to prospective accreditation customers."