User:Shawndouglas/sandbox/sublevel1

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This article is a sandbox article. This is a work in progress and not a completed article for the encyclopedic wiki mainspace.

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 loading

Requirement: sample loading screens optimized for the industry, including differentiation among medical and recreational marijuana, as well as hemp

Relevant LIMSpec:

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

Additional background: Should also support both remote sampling and in-lab sampling.

Pre-loaded cannabis testing protocols, labels, and reports

Requirement: pre-loaded compliant test protocols, labels, and reports optimized and readily adjustable for a rapidly changing industry (addressing COAs for batches and batch-by-batch variance analyses)

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: Should also have configurable test parameter/specification limits, while retaining older historic limit sets (e.g., https://www.limswiki.org/index.php/LabLynx_KB:SysAdmin_-_5.4_LIMS_system_setup).

Create and manage additional protocols, labels, and reports

Requirement: tools for creating new, compliant test protocols, labels, and reports

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:

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:

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:

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

  • support for accounting and billing

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

  • provide a secure web portal for results review

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

LIMSpec: MULTIPLE items

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. LIMSpec: 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. LIMSpec: 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. LIMSpec: 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. LIMSpec: 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. LIMSpec: 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. LIMSpec: 16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance. LIMSpec: 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. - 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) https://www.oregon.gov/oha/ph/LaboratoryServices/EnvironmentalLaboratoryAccreditation/Pages/Cannabis-accreditation.aspx Volume 1, "Management and Technical Requirements for Laboratories Performing Environmental Analysis," of the NELAC Institute, National Environmental Laboratory Accreditation Program (TNI NELAP) 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" 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

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


References

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