Regulatory agencies across the world are responsible for enforcing regulations for different industries. Industries must adhere to these regulations to assure the quality of their products and services. Getting accredited is expensive, time-consuming, as well as challenging as regulations keep changing. However, ignoring regulatory compliance could be a risk to the quality, public safety, and may lead to heavy penalties. Regulatory requirements may vary from one industry or laboratory to another and from one state or country to another. Some common regulatory compliance and best practices are ISO/IEC 17025:2017, GLP, HIPAA, EU GDPR, 21 CFR Part 11, CLIA, ISO 15189:2012, ISO 20387, GCP, GLP, FSMA, HACCP, and ISBER Best Practices.
Role of a LIMS in Following Regulatory Compliance & Best Practices
A LIMS can help laboratories across different industries, such as clinical, food & beverage, biobanks, to comply with the regulatory requirements and follow best practices. A LIMS helps laboratories in the following ways:
1. Enables following standards and best practices prescribed for an industry.
2. Manages all internal and external documents and tracks their revision history.
3. Automates and streamlines QA/QC processes and ensures traceability through the sample life cycle.
4. Enforces laboratory staff to follow Standard Operating Procedures (SOPs) to minimize procedural errors.
5. Supports validation and approval of multiple test results before releasing the test reports.
6. Maintains staff training records so that analytical tasks could be assigned to the competent staff to maintain the quality of test results
7. Helps schedule equipment calibration, records calibration and maintenance data, and prevents the use of outdated instruments.
8. Generates custom Certificates of Analysis (CoAs) as per reporting standards.
9. Enables maintaining a Chain of Custody (CoC) and a verifiable audit trail.
1. An overview of regulatory compliance and best practices for laboratories across different industries.
2. How a LIMS helps laboratories comply with the regulatory requirements and follow best practices to stay ahead of the curve.