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GxP & 21 CFR Part 11
QMS for Pharma & Life Sciences
GxP & 21 CFR Part 11 Compliant
Digital quality management system for pharmaceutical companies. SOP management, change control, electronic signatures and complete audit trails for GMP, GLP, GCP.
Challenges in Pharma & Life Sciences
21 CFR Part 11 Compliance
FDA requires electronic signatures, audit trails and validation of electronic systems. Paper-based processes are no longer contemporary.
SOP Management
Hundreds of SOPs must be kept current, trained and traceable. Every change requires change control and re-training.
Change Control
Every change to processes, equipment or documents must be documented, evaluated and approved. Impact analysis on validation status.
Deviation Management
Deviations must be systematically recorded, investigated and CAPA measures initiated. Trend analysis to prevent recurring problems.
Audit Readiness
FDA, EMA and other authorities can inspect at any time. All evidence must be immediately available – complete and traceable.
Validation & Qualification
IQ/OQ/PQ documentation, CSV (Computer System Validation) and revalidation upon changes. Complex documentation requirements.
The docxpert.io Solution for Pharma
5 Months
To GxP Certification
Average time from start to certificate
80%
Faster Audit Preparation
All evidence digital and immediately available
100%
21 CFR Part 11 Compliant
Electronic signatures and audit trails
Key Features for Pharma
SOP Management & Training
Central SOP management with version control, approval workflows and automatic training tracking. Read & Understood Acknowledgments with electronic signature.
Change Control
Structured change management with impact assessment, approval workflows and automatic linking to affected documents and systems.
Electronic Signatures (21 CFR Part 11)
FDA-compliant electronic signatures with two-factor authentication, audit trail and non-repudiation. Fully validated.
Deviation & CAPA Management
Systematic recording of deviations, root cause analysis and CAPA measures. Trend analysis to identify recurring problems.
Validation Documentation
IQ/OQ/PQ protocols, CSV documentation and revalidation. Structured storage of all validation evidence with traceability.
Audit Trail & Reporting
Complete logging of all actions with user ID, timestamp and reason for change. Audit reports with one click for inspections.
GxP & Regulatory Requirements Covered
docxpert.io fulfills all documentation-related requirements for GMP, GLP, GCP and 21 CFR Part 11
21 CFR Part 11 (Electronic Records)
EU GMP Annex 11 (Computerised Systems)
ICH Q7 (Good Manufacturing Practice)
ICH Q9 (Quality Risk Management)
ICH Q10 (Pharmaceutical Quality System)
ISO 9001 (Quality Management)
FDA Guidance on Data Integrity
ALCOA+ Principles
Change Control & Deviation Management
Training & Qualification Records
Start Your GxP Implementation
No credit card required. 14 days free trial. Personal onboarding support for pharma & life sciences included.