Quality and Regulatory Compliance 

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

Simplify Your Processes

Transform the way you manage quality and regulatory processes to meet GxP requirements as well as FDA 21 CFR Part 820, 21 CFR Part 11, and EU GMP Annex 11.

Audit Trails & E-Signatures

Track materials and critical processes with robust audit trails.

Quality Incidents


Gain visibility to trends that can inform strategic decisions.

Quality Audits


Streamline your quality audit processes.

Quality Inspections


Ensure safety, efficacy, and compliance.

Stability and Re-test

Maintain a record of quality re-test and stability processes.



Show that your application consistently produces results and meets specs and quality attributes.

Audit Trails &

Ensure your electronic data is secure and traceable. Track, document, and review regularly to meet regulatory requirements.

  • Navigate regulations and standards, and streamline processes to meet compliance requirements
  • Ensure compliance with FDA 21 CFR Part 11 & EU GMP Annex 11 
  • Apply multiple electronic signatures to a single record 
  • Capture the meaning of signature and sign with unique eSignature password 
  • Apply a flexible audit logic engine to any table and data set 
  • Gain complete documented control over essential, critical processes 
  • Rely on a comprehensive audit trail 
  • Export audit reports to various formats (PDF, Excel, Word, CSV, XML, MHTML, TIFF) 
  • Gain a “ready-to-print” audit report

Quality Incidents

Identify, investigate, and manage complaints, deviations, NCRs, CAPAs and all other quality incidents with transparency that benefits your entire organization.

  • Enable more effective corrective action and preventative action prioritization across the entire organization
  • Gain operational controls to ensure compliance with standard operating procedures when dealing with incidents, deviations, non-conformances, and CAPAs
  • Standardize procedures to ensure vigilance and compliance
  • Enforce and execute control over QA and QC processes
  • Leverage the information gathered to optimize processes across the organization
  • Monitor and identify vendor performance trends and report on raw materials quality tests
  • Gain deeper insights into quality incidents to help you anticipate and correct them before they even happen

      Quality Audits

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

      • Efficient planning and scheduling

      • Data security and confidentiality

      • Actionable, searchable data

      • Centralized and role-based secure access

      • Part 11 compliant audit trails with electronic signatures

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

      – Merit Solutions Customer: Publicly held, global commercial cell and gene therapies CDMO –

      Quality Inspections

      Ensure the safety, efficacy, and compliance of life science products by automating quality inspections with the rules your organization requires.

      • Ensure patient safety

      • Maintain product quality

      • Meet quality standards and regulatory requirements

      • Drive well-informed decisions

      • Create a comprehensive Certificate of Analysis with a click of a button

      • Protect continuity of operations

      Stability and Re-test
      Quality Testing

      Establish and follow processes to ensure the quality of materials and inventoried products.

      • Automatized way to help with proactive testing of materials approaching their retest date
      • Monitor the items’ stability or efficacy for safety reasons 
      • Ensure compliance by following your organizations SOPs for material re-test and stability testing 
      • Automatized and streamlined stability testing protocols 


      Ensure compliance with FDA 21 CFR Part 11 & EU GMP Annex 11 and have confidence that the software is fit for its intended use. 

      • Ensure compliance with FDAs 21 CFR Part 11 & EU GMP Annex 11 
      • Confidently manage security roles and identity 
      • Confirm solution software meets your quality SOPs 
      • Commercial off the shelf (COTS) application category for ISPE GAMP 5 Category 4 

      GxP Documents

      Fundamentally improve the quality and security of your quality and regulatory compliance documentation. Use cases include:

      •  Standard operating procedures (SOPs)
      • Employee certification requirements
      • Complaints
      • Investigations and CAPAs (Corrective Action Preventive Actions)
      • Electronic systems independent verification and validation (IVV)


      Quality White Paper

      Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. See how to unleash a new reality through increased transparency of quality data.

      Quality Controls Workshop

      Attend a free one-day briefing and review your business objectives, discover and visualize solutions, and leave with a clear, actionable picture of how to attain your business goals.

      Quality Ebook

      Learn what it takes to achieve consistent quality in the changing pharma, biotech, and med device landscape.