The Australian Therapeutic Goods Administration (TGA) carries out risk and safety assessments, standards enforcement and post-market monitoring on medicines and medicinal products.
Medicinal cannabis products are classed as medicines and, as such, are subject to the same regulatory framework and strict standards of safety, efficacy, and quality.
The recent change by the TGA to allow low dose cannabidiol (CBD) products to be sold over the counter by a pharmacist, without a prescription has led to additional limits on dosage form and packaging requirements, including pack size and child-resistant closures.
The slight easing of restrictions can only be a positive for a growing industry but brings with it even more regulations in a rapidly evolving cannabis industry.
Let’s take a look:
Traceability and Compliance
Trying to stay ahead of legislative requirements in a fast-paced environment is challenging and requires effective procedures to ensure the health and wealth of your Cannabusiness. The key is to provide complete seed-to-sale traceability from the growing plant through to the consumer. This can be achieved through effective tracking and reporting capabilities and ensures that cultivators, manufacturers, processors, supply chain and point of sale meet regulatory requirements.
To support complete traceability, a robust, industry-specific ERP solution is designed to integrate all aspects of seed to sale including:
Process Metrics and Reporting
Having key process metrics within your ERP solution will help keep your business accountable in meeting compliance requirements. By having a central, streamlined, and secure system, each solution becomes documented and repeatable enabling best practice and providing an audit trail. Whatever part you play in the seed-to-sale lifecycle, your ERP solution’s functionality needs to support you in meeting regulatory demands.
Inventory Management and Recalls
When evaluating an ERP solution that’s right for you, make sure that there is strong inventory management capability, automating track and trace record-keeping from seed to consumer.
Solutions that offer highly secure plant identification methods to track greenhouse inventory in real-time, and the monitoring and documented loss of inventory due to damage, shrinkage, accidental or wilful destruction also keep you in control of exactly what you have, and that all inventory is accounted for.
In the event of tainted produce or unsafe products, an ERP with product recall functionality is also a must-have. With the ability to forward and backward lot and serial and plant ID tracking, you can streamline supply chain and inventory transactions to ensure strict regulatory adherence is maintained.
Federal and State government reporting requirements can differ and so it is essential that your ERP has the capability to integrate with seed-to-sale tracking systems to ensure adherence to all legal requirements.
Data regarding audit compliance and potential breaches must be captured and shared to avoid any violation of compliance regulations that can have both a reputational, loss of earnings, or worse impact. Having the ability to integrate into state-administered systems saves time, money, and the negative impacts of non-compliance.
Tracing a Cannabis Strain
Having the ability to trace a product back to the strain makes compliance so much easier. An ERP solution that can efficiently trace a cannabis strain from seedling through to the final product, monitor its genealogy, ongoing clone potency, CBD, and THC content ratios assists with compliance-focused labelling.
With industry bespoke ERP’s, you can also record the health, weight, and growing conditions of each plant or group of plants throughout its lifecycle, as well as measuring the performance of a particular strain or variety to determine the best market for distribution and sale.
A Secure Platform
As well as compliance, it’s also important that information is safe from theft or fraud and so this also needs to be included as part of your evaluation checklist. Automated backups and redundancy plans are essential and user-based role permissions ensure secure access. The monitoring and recording of processes and transactions throughout growing, production and distribution leads to accountability and proper procedures being followed.
A high level of security helps your Cannabusiness to protect data and provide a robust audit trail to meet regulations.
Your Ideal ERP Scenario
Your Cannabusiness operates in a fast-moving environment where operations, markets, regulatory management, and compliance are constantly evolving. Strict adherence to the rules can be challenging in less complex industries with few being quite as rigid.
An industry-specific ERP solution understands the nuances of the Cannabusiness environment and has been built to effectively deal with managing critical business metrics such as inventory management, in-depth reporting, data security and complete transparency and traceability from seed to sale.
The perfect solution is one that can help you to deliver a compliant Cannabusiness whilst ensuring growth and competitive advantage.
And as your Cannabusiness evolves, your ERP adapts to meet your demands as you scale and grow.
Aptus Business Solutions
As a certified Sage and Nextec Partner, we have bags of experience in helping organisations navigate their way through the Cannabusiness ERP landscape.
From the outset, we get to know your pain points, listen to what’s working and show you where improvements can be made.
If you’d like to chat and discuss further, please get in touch or call 1300 998 594.