QUALITY AND QMS
Quality is priority in everything we do. Our systems and processes ensure peace of mind for our customers.
QUALITY STANDARDS
FDA Registered.
cGMP compliant processes and facility
ISO 9001:2015 and 13485:2016 Quality Management Systems
Detailed Standard Operating Procedures.
Comply with all applicable regulatory and trade compliance requirements.
Training program for all employees in place and documented.
Robust change control and risk management processes.
Continuous quality improvement processes
Controlled environment packaging and storage
QUALITY MANAGEMENT SYSTEM
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QCBD software suite QMS
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Manage document changes, revisions and deviations.
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CAPA - Manage corrective and preventive action processes
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Training Management.
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Supplier Management.
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Customer and Field Complaints
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Nonconforming Material Control
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Equipment Management
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Disaster Recovery Plan