Certificate of Analysis (COA)
An official document that certifies the quality and composition of a sample or product, providing analytical test results and compliance verification.
What is a Certificate of Analysis?
- Certificate of Analysis
- A Certificate of Analysis (COA) is a formal document issued by an authorized laboratory that provides detailed test results and certifies that a product or sample meets specified quality standards. COAs are essential for regulatory compliance, quality assurance, and supply chain documentation in pharmaceutical, food, environmental, and clinical testing industries.
Essential COA Components
COA Types by Industry
Pharmaceutical COA
Drug substance and product testing, stability studies, raw material verification
Environmental COA
Water, soil, air quality testing with regulatory compliance reporting
Food & Beverage COA
Nutritional analysis, contaminant testing, shelf-life studies
Clinical COA
Patient sample results for healthcare providers and patients
Cannabis COA
Potency, contaminants, terpene profiles for regulated products
LIMS-Generated COAs
Modern LIMS systems automate COA generation with features including:
Template Management
Customizable certificate templates per client or test type
Auto-Population
Automatic data pull from sample records and test results
Electronic Signatures
21 CFR Part 11 compliant digital signatures
Version Control
Track revisions and maintain audit trail
Distribution
Automated email delivery or client portal access
Archive
Secure storage with retrieval capabilities
Regulatory Considerations
COAs must comply with industry-specific regulations such as FDA requirements for pharmaceutical products, EPA requirements for environmental testing, and ISO 17025 for accredited laboratories. Proper COA management is often a focus during regulatory inspections.
Best Practices
Standardize Templates
Create consistent templates that meet all regulatory requirements
Validate Generation
Verify LIMS-generated COAs accurately reflect source data
Secure Storage
Maintain COAs in a secure, retrievable archive for the required retention period
Control Distribution
Track who receives COAs and when for audit purposes