eQMS · Enterprise Quality Management
Digitize, Automate & Simplify Quality Management
One validated platform for document control, CAPA, deviations, audits, change control, risk, training and supplier quality — built for regulated manufacturing.
- 21 CFR Part 11
- EU GMP Annex 11
- GAMP 5 validated
- ALCOA+
The case for change
Paper slows the quality system long before an inspection
Six patterns show up in almost every paper-based quality operation we replace.
Paper-based documentation
SOPs, forms and logbooks live in binders — retrieval is slow, versions drift and evidence is hard to prove.
Slow CAPA management
Investigations stall between departments, due dates slip and effectiveness checks are rarely closed on time.
Poor deviation tracking
Events are logged inconsistently across sites, so recurring root causes stay invisible until an inspection.
Audit readiness gaps
Every audit becomes a scramble to assemble records, approvals and training evidence from multiple owners.
Rising regulatory pressure
Part 11, Annex 11, Schedule M+ and ALCOA+ expectations keep tightening while headcount stays flat.
Fragmented quality systems
Spreadsheets, shared drives and point tools hold quality data with no single source of truth or trend view.
Paper process
Nexgensis eQMS
Signatures
Workflows
Records
Visibility
Intelligence
Traceability
Platform
One quality platform, built to be validated
Cloud-native architecture with compliance controls at the record level, so every product you add inherits the same evidence.
Cloud native
Multi-tenant, elastic and continuously delivered — no server estate to maintain.
Product architecture
Start with CAPA and documents, add products without a second integration project.
Compliance by design
Audit trails, e-signatures and data integrity controls built into every record.
AI-powered analytics
Predictive quality signals, root cause assistance and natural-language search.
Platform capabilities
- Workflow Automation
- Electronic Signatures
- Audit Trails
- Version Control
- Role-Based Access
- AI Root Cause Analysis
- Risk Matrix
- Notifications & Escalations
- Reports & Dashboards
- Mobile Support
- Cloud Deployment
- API Integration
Modules
Sixteen quality processes, one system
Adopt them in the order your quality roadmap needs. Every module shares the same records, roles and validation package.
Compliance & validation
Inspection-ready against every major framework
Controls are enforced at the record level, and every release ships with a GAMP 5 risk-based validation package.
FDA 21 CFR Part 11
Electronic records and signatures with secure, computer-generated audit trails.
EU GMP Annex 11
Computerised system controls, access management and periodic review evidence.
GAMP 5
Risk-based validation with pre-executed IQ/OQ documentation on every release.
WHO GMP
Quality system practices aligned to WHO expectations for regulated supply.
Schedule M+
Revised Schedule M documentation and quality system requirements supported.
ALCOA+
Attributable, legible, contemporaneous, original and accurate data at record level.
ISO 9001
Process approach, management review and continual improvement records.
ISO 13485
Medical device quality system controls including complaints and design records.
ICH Q10
Pharmaceutical quality system lifecycle with management oversight built in.
Outcomes
Measurable results, not slideware
Typical improvements reported by quality teams within the first year of running on Nexgensis eQMS.
- 0%
- Faster CAPA closure
- 0%
- Audit-ready evidence
- 0%
- Less documentation effort
- 0%
- Record traceability
- 0%
- Lower cost of quality
- 0%
- Training compliance
- 0×7
- Quality visibility
- 0%
- Productivity gain
Pharmaceutical Manufacturing
- Challenge
- Paper deviation and CAPA files across multiple formulation blocks.
- Solution
- Unified eQMS with deviation, CAPA, change control and training integration.
- Outcome
- Faster investigations and inspection-ready evidence on demand.
Medical Device Manufacturing
- Challenge
- Complaints, non-conformances and supplier files in separate systems.
- Solution
- ISO 13485 configured eQMS with complaint, NC and supplier products.
- Outcome
- Shorter complaint cycle time and a continuously audit-ready file.
Chemical Manufacturing
- Challenge
- EHS incidents and specification deviations tracked in spreadsheets.
- Solution
- eQMS with HSE, incident investigation and risk management.
- Outcome
- Faster incident closure and standardised controls across sites.
Food & Beverage
- Challenge
- Hygiene checks, supplier audits and recall traceability on paper.
- Solution
- eQMS with audit, supplier, non-conformance and recall management.
- Outcome
- Rapid traceability and paperless compliance across high-volume lines.
Delivery
A validated path to go-live in 8–12 weeks
- 01Assessment & DiscoveryProcess mapping, gap analysis and success metrics agreed with quality leadership.
- 02ConfigurationNo-code build of your forms, workflows, roles and site structure in your tenant.
- 03Integration & Data MigrationERP, MES and LIMS interfaces plus controlled migration of legacy records.
- 04Validation & UATGAMP 5 risk-based validation with pre-approved IQ/OQ and business user acceptance.
- 05Go-Live & HypercareCutover with on-floor support, then continuous improvement reviews.
Why Nexgensis
- AI-first platformIntelligence embedded in investigations, risk and reporting — not bolted on.
- Compliance by designPart 11, Annex 11 and ALCOA+ controls enforced at the record level.
- Rapid deploymentProduction quality operations in weeks, using pre-configured GxP content.
- Multi-site scalabilitySite-aware permissions, harmonised processes and global reporting.
- Product architectureAdopt products in the order your quality roadmap needs them.
- Deep domain expertiseBuilt by quality and validation practitioners for regulated manufacturing.
eQMS questions, answered
See Nexgensis eQMS on your quality processes
Book a working session, talk to our sales team or request the eQMS brochure. A quality systems specialist will respond within one business day.
- 45-minute working session, not a generic pitch
- Your deviation and CAPA workflow configured live
- Validation and compliance evidence walkthrough