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Chapter 3
Deliver innovative, effective, and safe products
Measuring compliance is critical, but in manufacturing, compliance alone is not enough. You must also continuously improve the quality of your operations and your products. With HSO and Merit for Life Science, you gain a comprehensive platform to establish and maintain a culture of quality while also supporting regulatory compliance.
You’ll manage end-to-end quality test points with granularity and meet the rigorous requirements of your industry with digital traceability. And, if you’re preparing for M&A activity, having both critical practices built into your operational system will make your company an attractive target.
Regulatory compliance
- Leverage an extensible digital framework that simplifies your process of meeting FHIR, HIPAA, and GxP requirements, as well as ensures 21 CFR Parts 11, 210, 211 and 820 compliance.
- Provide functionality to address: planning, compliance, quality, shelf life and retest, CAPA, controlled labels, electronic batch record / electronic device history record, audit management, weighing and dispensing, and instrument calibration.
- Guided compliance-related tasks such as procurement, dispensing, retesting, materials management, and others saves resources
Material management and control
- Prompt for QC tests where needed, track the status sent out to QC, and manage against the expected timelines while waiting.
- Manage various quality test points throughout the materials and production process. Manage those quality test points, either by having the system perform that task, or by managing the queue of tests that have to go to QC and back while production is held up.
- Ensure sampling rules associated with specific items are followed automatically. Use industry standards such as ANSI to drive sampling plansand different test plans for skip lot, qualification, re-qualifications, retest and stability testing protocols.
- Oversee the status of reported incidents from a centralized workspace and manage them to completion effortlessly.
- Keep comprehensive and auditable records of every reported incident. Ensure investigations can be performed across multiple people, facilities and geographies, knowing everything can be tracked and audited.
- Operationalize your standard operating procedures detailing what’s required when dealing with a non-conformance (NCR) and corrective action preventive action (CAPA.)
- Leverage automation to assign expiration dates to material batches and drive a proactive retest process (for inventory approaching expiration) to support a compliant process of re-certifying and extending expiration dates to avoid costly material loss.
- Perform quality tests in the system, setting up tolerances for acceptance for specific items. Use the ability to retest if you get a marginal failure result the first time.