Compliance and Operational Support (COS) provides integrated strategies and resources across cultivation, manufacturing, and quality systems in any operation.
Through a multifaceted approach, COS facilitates training and supportive resources to strengthen internal processes. By providing fundamental knowledge to key stakeholders, Compliance and Operation Support ensures a common language and culture within operations, with a key outcome being reputable quality.
Standard Operating Procedures (SOPs) are fundamental instructions to any production facility. Our COS experts work directly with clients to select the necessary SOPs for each unique business scope and regulatory environment. SOPs can be customized to suit specific needs. Support is provided to integrate SOPs at a functional department level, whether cultivation, extraction or, other processes.
The risk assessment and mitigation system assists with risk identification and audit preparedness. Action plans are customized for each facility and challenge which enables future independent improvements via quality management.
This is how we help achieve quality, not as a concept, but as a practice.
Product Safety Compliance is the effective management of risk associated with anything that could bring harm to the end consumer. Operating in a compliant environment increases quality, increases brand strength, and ensures the delivery of safe products to the consumer. Product safety procedures help to protect and mitigate against risk of product contamination, while compliance initiatives such as system validation and risk assessment provide a means of tracing and verifying the safety of the products. Following established guidelines and standards for product safety and compliance (such as BRCGS and FDA 21 CFR Part 11) streamlines these efforts. By addressing key elements of compliance in operations, including security, verifiability, traceability, auditability, and user management, product safety becomes a natural and provable reality. Ensuring product safety compliance at all levels of operation reduces the risk of error, product holds, or product recalls while increasing confidence in the products and brand.
Leveraging extensive experience in the industry, APIS supports comprehensive product safety and compliance solutions. Our solutions offer simple and powerful capabilities, including:
- Secure storage of crop and climate data by Batch or by lot
- Safety audit trails with lot traceability – who, what, where, when, and why
- Alarm notifications and optional security integration for personnel tracking (COVID-19 relevant)
- Information integration from multiple systems to one point-of-access
- Optional FDA CFR Part 11 compliance package
Contact us for an initial discussion, we would like to hear about your challenges and see if we can assist your operation. – APIS Integration Team