Our QA controls and strict adherence to Health Canada Regulatory Protocols, combined with the flexibility to customize procedures to meet specific client requirements, is your assurance that industry regulations and best practices are being executed and exceeded on your behalf.

 

​Compliance

The Accuristix Quality Assurance team ensures a GMP-compliant environment for your products, utilizing:

• Validated Quality Management System

• Validation and preventative maintenance programs for all systems, areas and equipment

• Continuous online facility temperature monitoring with alert/alarm notifications

• Deviation, CAPA and Change Control programs

• Employee GMP, SOP and client manual training programs

• And more

 

Resources and Training

Accuristix has highly qualified and trained QA resources at each of our facilities with:

• Experience in ALL GMP healthcare and regulatory requirements and In-depth knowledge of GUI-0069 compliance requirements

• Dedicated management to host and support Client and Health Canada audits

• Product hold and recall capabilities

• Inbound inspection and sampling programs

• And more

 

Narcotics and Controlled Substances

Accuristix QA oversees the storage and distribution of all narcotics, controlled drug and precursor products to ensure regulatory compliance to all Health Canada protocols related to:

• Management of vaults, cages, license submissions and OCS inspections

• Security systems monitoring

• Qualified QA associates on-site, including QPICs, AQPICs, RPICs and ARPICs

• Management of Chain of Signature shipments and related audit trails

• And more
   

Validation

Accuristix facilities, equipment and systems are validated by our internal team to regulatory requirements. Our validation expertise can also support your needs for facilities, systems and equipment qualification.

• Validation of facilities and storage areas to GMP and GUI-0069 requirements

• Validation of Warehouse Management and other systems to meet governance and data integrity requirements

• Equipment validation including performing IQ/OQ/PQ
   

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