[COMPLIANCE]
21 CFR Part 11

Full FDA electronic records and signatures compliance with audit trail and data integrity built in.

[VALIDATION]
GAMP 5

Software development lifecycle aligned with GAMP 5 categories ensuring validated, audit-ready deliverables.

[DATA_INTEGRITY]
ALCOA+

Attributable, legible, contemporaneous, original, and accurate data architecture preventing manipulation.

Software Development
PHARMACEUTICAL

Pharmaceutical
Software Development

Pharmaceutical manufacturing and R&D demand GAMP 5-compliant software with full validation documentation. Our batch record automation, LIMS integration, and quality management systems are developed following FDA 21 CFR Part 11 and EU Annex 11 requirements for electronic records and signatures.

[INDUSTRY_CHALLENGES]

Software Challenges in
Pharmaceutical

Strict regulatory requirements and data integrity standards create unique demands for pharma software.

GAMP 5 Validation

All computerised systems must be validated following GAMP 5 lifecycle methodology — requiring risk-based validation plans, IQ/OQ/PQ protocols, and comprehensive documentation.

Electronic Records & Signatures

FDA 21 CFR Part 11 and EU Annex 11 mandate secure electronic records with audit trails, electronic signatures, time stamps, and access controls to ensure data integrity.

Batch Record Automation

Electronic batch records must capture every process parameter, operator action, and deviation with complete traceability from raw material to finished product.

Data Integrity (ALCOA+)

Regulatory expectations for Attributable, Legible, Contemporaneous, Original, and Accurate data require robust software architecture preventing data manipulation.

[DEV_PROCESS]

Our 10-Step
Methodology

A GAMP 5-aligned approach ensuring validated, compliant software for pharmaceutical operations.

01

Requirement Gathering & Analysis

Close collaboration with plant operators, process engineers, and project stakeholders to capture precise functional and non-functional requirements.

Structured workshops, site walkthroughs, and interviews map existing workflows, define user roles, and identify critical pain points. The output is a prioritised requirements specification tracing every feature back to a measurable business objective.

02

Feasibility Study & Planning

Evaluate the technical, operational, and financial viability of the project through detailed planning covering cost estimates, resource allocation, and realistic timelines.

Engineers assess hardware constraints, integration complexity, regulatory requirements, and scalability needs to produce a clear go/no-go recommendation. The deliverable is a project charter with a phased roadmap, budget breakdown, and contingency plan.

03

System Design

Software architecture is engineered to align with validated requirements, selecting appropriate frameworks, communication protocols, and data models for the target environment.

High-level architecture diagrams, database schemas, API contracts, and UI wireframes collectively define every module and interface. Each design artefact undergoes peer review for scalability, fault tolerance, and compliance with relevant industry standards.

04

Development & Coding

Transform approved designs into production-grade code using languages and toolchains best suited to the application, from embedded C to modern web frameworks.

Development follows agile sprints with continuous integration, automated linting, and mandatory peer code reviews at every merge. Engineers adhere to industry coding standards where applicable, ensuring the codebase is secure, maintainable, and ready for long-term evolution.

05

Testing

Comprehensive, multi-layered testing strategy designed to surface defects early and validate performance under real-world industrial conditions.

The programme spans unit tests, integration tests across subsystems, full system tests simulating production loads, and formal user acceptance testing with plant personnel. Automated regression suites run on every build to catch regressions before they reach production.

06

Deployment

The validated software is deployed to the production environment through a controlled release process, minimising downtime and operational disruption.

Deployment includes installation on client servers or edge devices, environment-specific configuration, and end-to-end integration with existing SCADA, MES, or ERP systems. A structured rollback plan is prepared alongside go-live checklists for rapid issue resolution.

07

Maintenance & Support

Ongoing, proactive maintenance and dedicated support services to ensure the software continues to perform optimally as operational demands evolve.

The support framework includes scheduled patch releases, security updates, performance tuning, and feature enhancements driven by user feedback. Multi-year maintenance agreements provide guaranteed response times and remote diagnostics for long-term reliability.

08

Risk Planning & Mitigation

Potential technical, schedule, and compliance risks are systematically identified at every phase, with targeted mitigation strategies embedded in the project plan.

Risk registers are maintained and reviewed at each sprint boundary, covering third-party dependencies, cybersecurity threats, and regulatory shifts. This proactive discipline ensures emerging issues are addressed before they escalate, keeping the project on schedule and within budget.

09

Verification & Validation

Rigorous verification and validation activities with full requirements traceability, ensuring every specification is demonstrably met before release.

Verification confirms each module is built correctly through static analysis, inspections, and test coverage metrics. Validation proves the complete system fulfils its intended purpose in realistic scenarios, providing documented evidence for industrial certification.

10

Code Set & Documentation Audits

Regular, structured audits of the codebase and accompanying documentation to evaluate quality, scalability, maintainability, and standards adherence.

Independent reviewers examine code complexity metrics, dependency health, test coverage gaps, and documentation accuracy against the living design specification. Audit findings are tracked to resolution, ensuring the software is robust and straightforward to extend or hand over.

[DELIVERABLES]

What You
Receive

Validated, audit-ready pharma software with complete documentation.

Electronic Batch Records

Paperless batch record system capturing process parameters, operator actions, material tracking, and deviations with complete audit trail.

LIMS Integration

Bi-directional integration with Laboratory Information Management Systems for sample management, test results, and certificate of analysis generation.

Quality Management System

CAPA, deviation, change control, and document management workflow automation with electronic approvals and regulatory reporting.

Environmental Monitoring

Cleanroom temperature, humidity, pressure, and particle count monitoring with automated deviation alerts and trending reports.

Validation Documentation

Complete GAMP 5 validation package including URS, FS, DS, risk assessments, test protocols (IQ/OQ/PQ), and traceability matrix.

Serialisation & Track-and-Trace

Compliance with EU FMD and US DSCSA serialisation requirements for product tracking throughout the supply chain.

[EXPECTED_OUTCOMES]

Proven Results in
Pharmaceutical

Based on validated software deployments across pharmaceutical manufacturing and quality operations.

100%
Audit compliance maintained
70%
Paper-based processes eliminated
50%
Batch review time reduction
[PHARMA_FAQ]

Pharmaceutical
Software FAQ

Common questions about GAMP-compliant software development for pharma.

GET STARTED

Compliant
Software

Our pharma software specialists deliver GAMP 5-validated systems that pass regulatory audit.

  • Bespoke software for pharmaceutical
  • Pharmaceutical-specific compliance standards
  • Long-term maintenance & support included
Response Time
Next Working Day

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