Alphazyme quality solutions
QUALITY IS OUR FOUNDATION
Quality solution
Alphazyme was founded on the belief that “Quality” is far more than a set of specifications, a management system, or a department to assure compliance. Quality is the foundation of our business and a mindset that touches every aspect of our organization, team, and decision-making process.
Alphazyme is a manufacturer of molecular biology enzymes, featuring a growing portfolio of enzymes used for molecular biology applications in the fields of diagnostics and nucleic acid production for therapies. Our business is entirely focused on partnerships within the genomics industry, serving start-ups to Fortune 100 companies. Through PCR tests and mRNA vaccines, the global pandemic ushered “genetic literacy” to the forefront of medicine. A strong Quality Management System is central to Alphazyme’s ability to support these technologies, and Alphazyme selected the ISO 13485:2016 standard as the foundation of our Quality Management System based on its relevance to our molecular diagnostic industry partners and the Standard’s alignment, as a eQMS, with the FDA’s CFR 21 part 820.
Explore our Enzymes
QUALITY SOLUTIONS
Enzyme expertise and process controls
- Full product lifecycle traceability within our eQMS:
- Comprehensive design history files
- Full equipment traceability
- Stage-appropriate labeling/product Certificates of Analysis
- Formal review, approval process on all development and production documentation
- Comprehensive batch records for each product lot
- Purpose-build enzyme production facility:
- Vertical integration of all enzyme development, production, and testing operations
- BSE/TSE compliant environment
- Access-controlled laboratory suites separated by function
- Environmental controls (single-pass HEPA filtration, pressure/temperature/humidity monitoring)
- Production Process Controls:
- Complete training history files for all staff
- Process development tracked in electronic lab notebooks, with reviews/approvals
- Formal production batch records, with product grade-appropriate oversight
- Full set of QC tests to support life science and diagnostic use-cases
- Audit-readiness:
- eQMS system supports rapid retrieval/sharing of critical documents
- Auditors granted limited eQMS access to facilitate “remote” auditing
- ISO 13485:2016 certification