Thank you to all who attended OnQ Software & Perkin Elmer's Dairy, Meat, Grain and Animal Nutrition Webinars.

We were very pleased to present at the 4 webinars over the last fortnight together with Perkin Elmer and would like to thank everyone who attended.

If anyone would like more information about automated data management and reporting solutions using LIMS to streamline your business in:

• Dairy
• Meat
• Grain
• Animal Nutrition

Perkin Elmer focused on analytical techniques to authenticate and protect the integrity, safety and quality of the products.

The LIMS focus was on enabling scientists to do less admin and more science.

Please reach out for a demonstration - info@onqsoft.com.au

5 laboratory informatics enablers to help working remotely

With COVID-19 forcing many companies into undergoing a rapid and often premature digital transformation this can raise challenges for the business units.

In the laboratory it is almost impossible to perform all work remotely and we have seen multiple strategies such as rotating shifts to avoid infection and those who can work from home do so.

One of the main enabling factors is having the right laboratory informatics, LIMS, ELN and supporting infrastructure.

Here are 5 lab informatics enablers to help manage a lab remotely;

1. Browser based LIMS

This mean a LIMS which can be accessed via a web browser without having to download plugins making access as easy as possible.

It doesn't necessarily mean a cloud hosted LIMS or SaaS solution, although that can definitely help. 

Gaining access from your vendor or internal IT team is much easier this way without the hassle of downloading extra programs and adding weight to the network.

2. Digital signature capabilities - 21 CFR Part 11

21 CFR Part 11 defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.

What this means is that once work is complete a lab manager or supervisor can review and approve samples remotely and the whole process is properly audited.

A flexible system can provide the same durability to other processes too.

An image of the signature should also be electronically applied to final reports.

3. Built in reporting and business intelligence

Your LIMS should be able to provide you with access to all the reports needed to continue daily operations as well as necessary management information. For example:

• Certificate of Analysis
• Statistics and productivity reporting
• Worksheet generation and monitoring
• Material re-ordering information
• Instrument maintenance schedules
• many more...

The ability to quickly and easily generate these remotely lets a lab manager maintain a watchful eye over the lab.

Business Intelligence dashboards like the below QLIMS example are excellent for real-time operational data and management information.

4. Online/easy access to support  - understanding SLA's

We can often get caught up in a system's features and forget that a complete solution is made up of the system, people and processes.

Having access to an online support portal and knowledge base helps with the transition as you can still easily get help from your vendor(s).

Ensuring that your service level agreements (SLA) match your businesses working practice is important as when crisis strikes you know how quickly to expect a response. We'll go into this in more detail in another blog post.

Photo by CDC on Unsplash

In conclusion the above really aren't just for remote working, but also the signs of modern technology and good practices. In the new normal to follow COVID-19 we may be required to work remotely more and the above points can help in making sure we are setup to succeed.

For more information about systems to help contact OnQ Software.

QLIMS for Cannabis Companies - Part 3 of 3: Medicinal Cannabis Manufacturing

The final part of this series will focus on how QLIMS supports the manufacturing of medicinal cannabis products.

The focus will be data management, final product formulations, compliance with GMP guidelines and workflow tracking.

Medicinal Cannabis Manufacturing

A large number of medicinal cannabis facilities set up across Australia are focused on manufacturing for local and exporting. As such the sampling numbers are going to be very high so a system to effectively manage all that data, maintain traceability and help keep compliant with GMP will be important.

As seen from our previous posts, no matter what data you are looking to record and track a LIMS can help.

How can QLIMS help you?

1.Manage the metadata associated with each stage of the manufacturing process including:

1. Extraction
2. Filtration
3. Purification
4. Final product formulation

2. Track chain of custody from suppliers to third party testing of raw ingredients and final products

4. Automatically flag samples that are out of specification

3. Ability to capture subsidiary data including COA's against individual samples and batches

4. Create and Manage final and intermediate product formulations against batches, recording accurate quantities of raw ingredients

5. Track consumables used during the extraction, filtration and purification process and integrate with existing inventory management systems for full scale tracking and ordering of consumables.

7. Print barcodes and labels for end-to-end  traceability of samples

8. Track complaints and presentative actions in accordance with ISO17025

9. Business Intelligence Reporting - Including cost per batches, cost of consumables used during the the manufacturing process

These are some of the major areas where QLIMS can assist with GMP compliance and improve automation at your manufacturing facility. 

Stay tuned for further posts on how QLIMS can assist lab groups to work remotely under the current difficult circumstances.

QLIMS for Cannabis Companies - Part 2 of 3: Research and Analytical Labs

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!

QLIMS for Cannabis Companies - Part 1 of 3: Cultivation

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!

Upcoming conferences to meet the OnQ Software team

Conference trail update for first half of 2020:

- ACannabis (Melbourne) - March 2nd to 4th - PharmOut Australian Medical Cannabis Conference (Melbourne) - March 23rd to 24th - Future Labs (Melbourne) - June 15th to 17th Please feel free to come and speak to us about QLIMS, Clarity LIMS, digital pathology and anything lab informatics. There will be some exciting overseas locations in the second half of the year to in conjunction with our distribution network. hashtag

What to look for when using a LIMS to help with ISO 17025 for starters

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

What is ISO 18025?

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.