Regulated Software & Data Systems
Need end-to-end software development for your medical device concept?
Seeking help with regulatory-compliant software and cybersecurity?
Interested in rigorous verification and validation for your software's reliability and safety?
How confident are you in the integrity of your data across its entire lifecycle?
Have you fully assessed the risk of data breaches and their impact on patient safety and product quality?
How prepared is your team to handle a regulatory inspection focused on data integrity?
How do you validate the software and systems handling your sensitive data for compliance?
Build regulated software that holds up under inspection.
Medical device software, computer system validation, and data integrity — engineered for GxP environments and designed to pass audits, not just work on launch day.
Software in regulated life sciences has two jobs: it has to work, and it has to prove it works — to FDA inspectors, notified bodies, and auditors years after release. Teams that treat compliance as a post-launch cleanup end up rewriting their architecture, their test evidence, or both. We build it in from the start: IEC 62304-aligned development, Part 11-compliant data handling, validation documentation that regulators actually accept.
Our Comprehensive Services:
1. Medical Device Software Development (Read more)
End-to-end development for Software as a Medical Device (SaMD) and software-in-a-device, aligned with IEC 62304, ISO 14971, and FDA pre-market submission expectations. From architecture through verification, validation, and technical file.
2. Computer System Validation (CSV)
Validation of GxP systems — EDC, LIMS, eTMF, QMS, ERP, clinical platforms — under GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11. Risk-based, right-sized, and delivered without the traditional CSV overhead.
3. Data Integrity & ALCOA+ (Read more)
ALCOA+ data integrity programs for clinical, manufacturing, and lab environments. Audit trail design, electronic signature workflows, and data lifecycle controls that survive regulator scrutiny.
4. Cloud, SaaS & Legacy Modernisation
Validated migrations from on-premise to cloud, vendor qualification for SaaS platforms, and modernisation of legacy GxP systems — without losing compliance continuity.