Quality / Digital / Software
eQMS workflow digitisation
Moving deviation, CAPA and change control from paper forms to linked electronic workflows.
Illustrative use caseCapability
Regulatory, Quality & Documentation Practices
GxP compliance, validation and documentation practices that make pharmaceutical work traceable, reviewable and inspection-ready.
What we do
Quality is designed into how work is planned and recorded, not added at the end. We help teams build procedures, validation packages and quality records that are proportionate, consistent and easy to review.
DGXPComplianceLab does not issue certifications or regulatory approvals. We support organisations in meeting the expectations of the frameworks below.
Where it fits in the pharmaceutical lifecycle
Typical activities
Each activity shows who performs it. We do not claim facilities we do not own.
DGXP-led Led by the DGXPComplianceLab team Partner-coordinated Performed by a qualified partner, coordinated by us
GxP gap assessments
DGXP-ledCurrent practice compared with applicable expectations.
Computerised system validation
DGXP-ledCSV and CSA plans, testing and reports.
Data integrity programmes
DGXP-ledData flow mapping, audit-trail review and ALCOA+ controls.
Quality risk management
DGXP-ledFMEA and risk ranking per ICH Q9(R1).
Documentation practices
DGXP-ledSOP systems, templates and good documentation practice.
Audit readiness
DGXP-ledMock audits, storyboards and CAPA follow-up.
Regulatory documentation
DGXP-ledCMC inputs, change assessments and submission support documents.
Frameworks we work with
Support for meeting these expectations. No certification or regulatory approval is implied.
GxP / GMP
Good practice for manufacturing and quality systems (21 CFR 210/211, EU GMP).
GLP / GCP
Non-clinical laboratory studies and clinical trial conduct.
GDP
Good distribution practice for storage and transport.
21 CFR Part 11
Electronic records and electronic signatures (US FDA).
EU Annex 11
Computerised systems in EU GMP.
Data integrity & ALCOA+
Attributable, legible, contemporaneous, original, accurate — complete, consistent, enduring, available.
CSV / CSA
Computerised system validation and risk-based computer software assurance.
AI validation
Fit-for-intended-use evidence for AI-enabled systems.
Risk management
ICH Q9(R1) quality risk management across the lifecycle.
Document examples
Documents we write, review or structure within projects.
- SOP
- Validation Plan
- User Requirement Specification
- Functional Specification
- Risk Assessment
- Test Protocol
- Test Script
- Validation Report
- Change Control
- Deviation
- CAPA
- Batch Documentation
- Quality Agreement
Validation document flow
- 1Validation plan
- 2URS
- 3Risk assessment
- 4FS / DS
- 5Test protocol
- 6Test execution
- 7Deviation handling
- 8Validation report
- 9Periodic review
Technologies and processes
- GxP
- GMP
- GLP
- GCP
- GDP
- 21 CFR Part 11
- EU Annex 11
- Data Integrity
- ALCOA+
- CSV
- CSA
- AI Validation
- ICH Q9(R1) Risk Management
Example projects
Illustrative use cases showing how this capability is typically applied.
AI / Quality / Software
AI validation framework
A validation approach for AI-enabled GxP applications, from intended use to monitoring.
Illustrative use caseRegulatory / Manufacturing / Quality
Technology transfer documentation
Building a complete documentation set for transferring a product between sites.
Illustrative use caseOur project execution model
Every engagement follows the same eight steps, scaled to the size and risk of the project.
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01
Understand
Understand business and technical requirements.
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02
Assess
Assess scientific, technical, regulatory and operational requirements.
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03
Design
Design the appropriate solution.
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04
Identify
Identify appropriate internal and external capabilities and partners.
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05
Execute
Coordinate and execute the project.
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06
Verify
Test, verify, qualify or validate where applicable.
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07
Document
Create technical, quality and regulatory documentation.
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08
Improve
Monitor, optimise and continuously improve.
Related services
AI Governance & Validation
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Technology & Engineering
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Pharmaceutical Software
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Frequently asked questions
Do you certify companies as GMP compliant?
No. Certification and approval come from regulators and accredited bodies. We help organisations prepare and improve.
What is the difference between CSV and CSA?
CSA is FDA’s risk-based approach to computer software assurance: it focuses effort on features that affect product quality and patient safety and accepts unscripted testing where risk is low. CSV is the broader validation discipline.
Can you write our SOPs?
Yes — procedures written with your process owners so they reflect how work is actually done.
Discuss a regulatory & quality requirement
Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.