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
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Gain visibility to trends that can inform strategic decisions.
Quality Audits
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Streamline your quality audit processes.
Quality Inspections
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Ensure safety, efficacy, and compliance.
Stability and Re-test
Maintain a record of quality re-test and stability processes.
Validation
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Show that your application consistently produces results and meets specs and quality attributes.
Audit Trails &
E-Signatures
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
Validation
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)
Resources
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.