EDMSNext for GxP environments is a compliance-ready document management platform designed to meet the strict requirements of Good Practice (GxP) regulations. It helps regulated organisations maintain data integrity, audit readiness, and controlled document lifecycles.
EDMSNext for GxP Environments
EDMSNext for GxP environments enables pharmaceutical, biotechnology, medical device, and life sciences organisations to manage documents in accordance with GMP, GDP, GLP, and GCP requirements. The platform ensures documents are controlled, traceable, and inspection-ready at all times.
What Is EDMSNext for GxP Environments?
EDMSNext is purpose-built to support GxP-regulated operations by enforcing document control, approvals, access management, and audit trails. It replaces manual systems and shared drives with a validated, compliance-first document platform.
Why GxP Organisations Choose EDMSNext
- Strict regulatory compliance and audit readiness
- End-to-end document traceability and control
- Data integrity and controlled change management
- Reduced risk of regulatory findings
Supported GxP Regulations
- Good Manufacturing Practice (GMP)
- Good Distribution Practice (GDP)
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP)
- FDA 21 CFR Part 11 and global equivalents
Core GxP-Compliant Capabilities
- Controlled document creation, review, and approval
- Version control with full revision history
- Role-based access control and segregation of duties
- Comprehensive audit trails and electronic records
- Retention, archival, and compliant document disposal
GxP Use Scenarios
- SOP and policy management
- CAPA, deviation, and change control documentation
- Validation and qualification records
- Audit and inspection readiness
How EDMSNext Reduces GxP Compliance Risk
EDMSNext enforces approved workflows, prevents unauthorised changes, and maintains immutable audit trails. These controls help organisations demonstrate compliance during regulatory inspections and reduce the risk of observations or warning letters.
Manual Systems vs EDMSNext for GxP
- Manual systems: High risk of errors, missing approvals, and audit findings
- EDMSNext: Automated, validated, and inspection-ready document control
Who Uses EDMSNext in GxP Environments?
- Quality assurance and compliance teams
- Regulatory affairs professionals
- Manufacturing and laboratory operations
- Clinical research organisations
Next Steps for GxP Organisations
- Assess current document control gaps.
- Prepare for upcoming audits and inspections.
- Adopt a GxP-ready document management platform.
Explore how EDMSNext supports regulated environments: Features | Use Cases | Industries | Locations
Ready to validate EDMSNext for your GxP environment? Book a demo or contact our team.
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Frequently Asked Questions
Is EDMSNext compliant with GxP regulations?
Yes. EDMSNext supports GMP, GDP, GLP, GCP, and FDA 21 CFR Part 11 requirements with audit-ready controls.
Can EDMSNext support FDA inspections?
Yes. The platform provides controlled access, version history, and audit trails required during FDA inspections.
Does EDMSNext support electronic records and approvals?
Yes. EDMSNext supports electronic records, approvals, and traceability aligned with regulatory expectations.
Who should use EDMSNext for GxP?
Pharmaceutical, biotech, medical device, laboratory, and clinical research organisations operating under GxP regulations.
