• Extraction
• Filtration
• Purification
• Final product formulation

The next part in our series will focus on how QLIMS can help with the extraction, research and testing of medical cannabis, with a focus on data management, quality, inventory, stability testing and regulatory standards.

Medical Cannabis Testing & Quality Assurance

With the large number of cultivation facilities currently set up or in the process of being implemented across the country, Medical Cannabis testing labs will see a massive magnitude of samples that will require testing and processing will be difficult to manage with just spreadsheets or paper-based systems. Furthermore, using spreadsheets is simply not enough to comply with the regulatory guidelines as there no audit trail tracking your samples, across reception, testing and disposal.

LIMS plays a significant role in overcoming such data management and trace ability challenges.

How can QLIMS help you?

End to end Batch & Sample Workflow Management 

Data and Quality Management

• Record, manage and track tests for
  • Potency of cannabinoids
  • Presence of terpenoids
  • VOCs
  • Moisture Content
  • Microbiological contaminants etc.
• Record SOP’s and automate QA/QC Protocols
• Track chain of custody
• Create standard protocols to manage shelf-life stability testing

Inventory Tracking and Automation

• Manage inventory, including reagents and all other lab consumables
• Integrate with LC’s, GC’s, ICP’s for complete automation of result entry and reduction in human error
• Generate COA’s and any other customised test/compliance reports
• Integrate to seed-to-sale systems, ERP’S, finance and billing systems etc. for end-to-end automation
• Print and scan barcodes

Improved Regulatory Compliance

• 21CFR Part 11 compliance
• Validate tests and results
• A secure, searchable and reportable audit trail for Increased transparency throughout all lab operations
• Track “cradle to grave” for all samples

These are just a few areas where a robust LIMS can improve your laboratory and business practices. By being modular, tracking the subsidiary and allowing for integration to any other systems involved in your medicinal cannabis laboratory, a professional LIMS such as QLIMS acts as an extension to your staff’s scientific skills and forms a critical part of the supply chain.

Stay tuned for our next post in the series discussing how a LIMS assists with manufacturing of your final Medical Cannabis products!

In the lead up to ACannabis and AMCC 2020 conferences in March we are releasing a series of blog posts on how your organisation can implement laboratory informatics that can streamline your quality assurance processes right from cultivation to testing and finally manufacturing the medicinal cannabis product.

The first part of this series will focus on how QLIMS, Laboratory Information Management System, can help manage your cultivation facility and processes, with a focus on data management, quality, inventory and training management.

QLIMS and Cultivation

This is especially relevant for groups who are in the process of setting up or have already completed the set up of their cultivation facilities and are looking to implement a system to manage their plant yields, harvests and record each stage of the cultivation process

How can QLIMS help you?

Managing plant material and stages of cultivation:

• Generate unique ID’s for end-to-end trace ability of plant samples, batches and harvests
  Segregate the different stages of cultivation by allocating a sample type to the batches associated with each stage
  Split plant samples into clones with trace ability back to the mother plant
  Track storage and disposal of plant materials
  Record wet, dry, trim and cure yields for harvests
  Set up automated calculations (Eg: Calculating moisture loss)

Maintaining product quality and consistency:

• Ensure only trained staff are performing any methods/techniques
  Track equipment maintenance and efficiency
  Document SOP’s to ensure staff follow repeatable processes
  Record all metadata (pH levels, temperature, humidity, water nutrients) at each stage of the process
  21 CFR Part 11 compliance
  Manage stability studies

Managing cost and staying competitive in the market:

• Track the current quantity and cost of raw materials, reagents and consumables
  Use a Business Intelligence suite to track the cost of nutrients and materials used for growing plants
  Create interactive charts to track batch/plant/strain yields to determine which is the most profitable
  Track turnaround times by task or staff

These are just a few areas where a robust LIMS can improve your cultivation and business practices. By being modular, tracking the subsidiary and allowing for integration to any other systems involved in a medicinal cannabis facility, a professional LIMS such as QLIMS acts as an extension to your staff’s scientific skills and forms a critical part of the supply chain.

Stay tuned for our next post in the series discussing how a LIMS assists with extraction and analytical testing!

This blog will give you an introduction into the basics of ISO 17025 and just some of the requirements that LIMS can help with.

What is ISO 17025?

ISO 17025 is a laboratory accreditation standard that all testing and calibration laboratories vie to achieve to prove their technical competence in performing an array of testing, calibration and measurements for standard, non-standard and laboratory-developed methods.

As the accreditation is almost entirely lab-centric, it comes as a no-brainer that a Laboratory and Information Management System (LIMS) has an important role to play. The central idea of ISO 17025 is recording everything that happens in the lab in terms of technical quality; as such traditional record-keeping methods like Excel, Access DB and paper do not ‘cut-it’ anymore. While for a LIMS this is part of its basic core functionality.

Why do you need accreditation in the first place?

To ensure quality of course! An ISO 17025 accreditation helps labs to improve their reputation among current and prospective clients, gain a competitive advantage, meet international compliance standards and ultimately reduce costs. With such an accreditation in place your lab is effectively providing prospective clients with the assurance that it is strongly committed to providing quality products.

What are some of these requirements?

How is a LIMS going to help you?

• End to end sample data tracking can be monitored via a comprehensive audit trail that records every single change made to a sample

• Keeps track of all staff training records and qualifications to ensure that staff are certified to conduct the testing

• Tracking the maintenance and calibration of instruments as well as notifying lab staff when they use an instrument that is out of calibration

• CFR 21Part 11 compliance provides that added level of quality to have an e-signature where validation of tests and test results are concerned

• An inventory management system for tracking all lab consumables, including quantities, expiry dates, supplier information and MSDS’s

• Managing, maintaining and updating SOP’s

• Automatically generate CoA’s

• Tracking chain of custody by recording what testing the samples have been sent out for, where they have gone and when they are due back

• CAPA (complaints and preventative actions) functionality can assist users in recording any major incident at the lab as well as the corrective and preventative actions in place to resolve the incident

As the ISO standards and regulatory requirements for analytical labs are constantly evolving, there is a need to implement a quality management system that can keep up with these requirements. Especially with increasing sampling numbers Excel and paper-based methods are no longer able to meet the demanding requirements for an ISO 17025 certification. The best method to meet these challenges is turning to automated solutions, like LIMS, that eliminate mundane tasks that exploit valuable resources.