Life sciences
Medtech scale-up aligns GxP with agile release cadence
Balance between fast releases and traceable validation for quality systems and product software.
Client challenge
Audit findings on test documentation; tension between R&D velocity and QMS requirements.
bayata approach
Risk-based validation, automated regression tests, release board with QA/RA and frozen builds.
Measured outcome
Predictable releases with full audit trail; less rework after inspection.
Release cycle from 10 to 4 weeks with no major findings in external audit
Services
- Software Development
- Change Management