> Digital quality management for pharma & life sciences. GxP, 21 CFR Part 11, SOP Management, Change Control, Electronic Signatures. Baseline from €89/month; credit packages priced separately.

Source: [https://docxpert.io/en/use-cases/pharma](https://docxpert.io/en/use-cases/pharma)

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.

[View All Features](https://docxpert.io/en/features)

## 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.

[Mehr erfahren](https://docxpert.io/en/features/document-management)

Change Control

Structured change management with impact assessment, approval workflows and automatic linking to affected documents and systems.

[Mehr erfahren](https://docxpert.io/en/features/approval-workflows)

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.

[Mehr erfahren](https://docxpert.io/en/features/capa-management)

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.

[Book Demo](https://docxpert.io/en/features)

## Other Industries & Use Cases

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