Software / Quality / Digital
Pharmaceutical document management system
A controlled document lifecycle with review, approval, effective dates and archive.
Illustrative use caseCapability
Pharmaceutical Software Solutions
Software designed around pharmaceutical workflows — requirements, workflow design, validation and documentation included from the start.
What we do
Pharmaceutical software has to do two jobs: support the work, and produce records that stand up to inspection. We design for both — role-based access, audit trails, electronic signatures and data integrity controls are requirements, not add-ons.
Our software work covers requirements, design, build, validation and documentation for document management, learning, quality and compliance tools.
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
Software requirements
DGXP-ledUser requirements, intended use and regulatory impact assessment.
Software design
DGXP-ledFunctional and technical design with traceability.
Workflow design
DGXP-ledStates, roles, approvals and notifications for GxP processes.
Validation
DGXP-ledRisk assessment, test scripts, evidence and validation report.
Quality systems
DGXP-ledDeviation, CAPA and change-control applications.
Documentation
DGXP-ledUser guides, SOPs and administrator procedures.
AI-enabled applications
DGXP-ledAssistive AI features with governance controls.
Learning platforms
DGXP-ledTraining management with assessments and certificates.
Document management
DGXP-ledControlled document lifecycle and distribution.
Compliance tools
DGXP-ledChecklists, registers and inspection-readiness tools.
Illustrative solutions
Examples of the workflows we design and build. Illustrative solution / example
Pharmaceutical Document Management System
DraftReviewApprovalEffectiveRevisionArchive
Controlled documents with version history, periodic review, read-and-understood training links and Part 11 e-signatures.
Pharmaceutical Learning Management System
CourseModuleTrainingAssessmentCompletionCertificate
Role-based curricula, SOP-linked retraining, assessments and verifiable completion certificates.
Pharmaceutical Validation Platform
RequirementRiskTestingEvidenceApprovalValidation report
Requirements traced to risk, test scripts and objective evidence, with approval workflow and generated reports.
Areas we work on
- Software requirements
- Software design
- Workflow design
- Validation
- Quality systems
- Documentation
- AI-enabled applications
- Learning platforms
- Document management
- Compliance tools
- Digital pharmaceutical tools
Software lifecycle
- 1Intended use
- 2Requirements
- 3Risk assessment
- 4Design
- 5Build
- 6Test
- 7Validation report
- 8Release
- 9Periodic review
Technologies and processes
- PHP / MariaDB
- Role-based access control
- Audit trails
- Electronic signatures
- 21 CFR Part 11
- EU Annex 11
- GAMP 5 Category 4/5
Example projects
Illustrative use cases showing how this capability is typically applied.
Training / Software / Digital
Pharmaceutical training management platform
Course, module, assessment and certificate management linked to controlled documents.
Illustrative use caseQuality / Digital / Software
eQMS workflow digitisation
Moving deviation, CAPA and change control from paper forms to linked electronic workflows.
Illustrative use case
AI / Quality / Software
AI validation framework
A validation approach for AI-enabled GxP applications, from intended use to monitoring.
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
Digital Transformation
Converting paper-based and fragmented pharmaceutical processes into controlled, connected digital workflows that stay c…
AI Governance & Validation
AI is not implemented simply because it is available. In pharmaceutical work it needs an intended use, a risk assessmen…
Regulatory & Quality
GxP compliance, validation and documentation practices that make pharmaceutical work traceable, reviewable and inspecti…
Frequently asked questions
Are these off-the-shelf products?
The solutions shown are illustrative examples of what we design and build. Scope, configuration and validation are agreed per project.
How are electronic signatures handled?
Signatures are linked to unique user identity, the meaning of the signature and a timestamp, and cannot be removed or copied — per 21 CFR Part 11 §11.50–11.70.
Can software run on standard hosting?
Many workflow tools can. Hosting, backup, security and supplier controls are assessed as part of validation.
Discuss a pharmaceutical software requirement
Share the product, stage and timeline. Capability is confirmed after technical assessment and partner availability.