Quality and Regulatory Compliance 

Digitize your operational processes to
simplify compliance and gain real-time visibility.

Simplify Your Processes

For meeting GxP requirements, as well as the FDA 21 CFR Part 820, 21 CFR Part 11 compliance, and EU GMP Annex 11.

Audit Trails & E-Signatures

Track materials and critical processes through the system with robust audit trails.

Quality Incidents

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Gain visibility to trends that can inform strategic decisions

Quality Audits

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Streamline your quality audit processes

Stability and Re-test

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Validation

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Demonstrate your applications

Audit Trails &
E-Signatures

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Quality
Incidents

Identify, investigate, and manage quality incidents with transparency that benefits your entire organization.

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Quality
Audits

Improve efficiency by automating processes for planning and executing your audit programs.

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From quality inspections to enforcing quality holds and remediation, Merit for Life Science with D365 ensures compliance with our quality management system.

- Publicly held, global commercial cell and gene therapies CDMO

Stability and Retesting
Quality Testing

 Identify, investigate, and manage quality incidents with transparency that benefits your entire organization.

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Validation

Improve efficiency by automating processes for planning and executing your audit programs.

 

“Validation is a process of demonstrating, through documented evidence, that <software applications> will consistently produce the results that meets predetermined specifications and quality attributes.”

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Quality White Paper

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Quality Controls Workshop

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Quality Ebook

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