Work
A project and quality management platform for regulated pharma
A platform that digitalises project and quality management for pharma companies, built as separately enabled modules on one foundation, with audit-ready documentation for regulated environments.
- What it proves
- That we can take a regulated-industry product from strategy to a fully developed platform, and keep it coherent across more than a dozen modules.
- Method stages
- Built from
- One platform, separately enabled modules
- Live dashboard per module
- Traceability from requirement to test
- Electronic signatures and execution evidence
- Audit-ready documentation
- Sectors
The problem
IT projects in regulated pharma carry two jobs at once: deliver the system, and prove how it was delivered. Project plans, specifications, test evidence, change records and training sign-offs usually live in separate tools. Assembling them for an audit is slow, and tracing a requirement to the test that covers it takes manual effort.
What we built
One platform, made of modules that a customer enables separately. Every module has its own live dashboard, so the person responsible sees the state of their area without a report being compiled.
- Portfolio and project management
- Design and development, with traceability between requirements, specifications and tests
- Knowledge sharing
- Document management with electronic signing
- Incident, change and configuration management, including version control
- Deviations, including adverse events, and CAPA (corrective and preventive action)
- Test management, with electronic execution and the evidence captured as the test runs
- Training, with read-and-understood sign-off
- Complaints
- A light CRM
- Risk management linked to requirements, specifications and design control
Because the modules share one foundation, a deviation can point to the change that fixes it, and the change to the tests that re-verify it. Documentation is produced as the work happens, in a form made for audit in a regulated environment, including GxP contexts.
What it changes
Teams stop reconciling several tools to answer one auditor’s question. The record of who decided, who signed and what was tested builds up as a by-product of doing the work. We helped strategise, pilot and scale the product to speed up IT project delivery. It was fully developed and used in investor pitches.
Method stages
The engagement ran across Stage 01 · Ground the case, Stage 03 · Engineer the system, Stage 04 · Pilot in one place and Stage 05 · Scale what works. See the KARPINITY Method.