Questioning the status quo. Anticipating needs.

Understanding the process

Before a system can be validated, the process behind it has to be understood.

We work with the people who perform the work, because that is where the real requirements are found: what the system must do and why. By challenging assumptions, mapping workflows and tracing data flows, we expose bottlenecks, vulnerabilities, dependencies and opportunities to redesign the process before it is digitised. A better process is easier to automate, easier to validate and easier to keep under control.

Defining testable requirements

Requirements are linked to intended use, operational needs and the applicable regulations: GMP predicate rules, 21 CFR Part 11, EU GMP Annex 11 and others. Records, controls and data flows are assessed together, because compliance starts long before testing does.

Establishing control

Validation is about control. We identify where data is created, transferred, reviewed, approved and retained, and which of those points require controls. Predicate rules define what records must exist. Technical controls keep them trustworthy throughout their lifecycle and are more reliable than procedural controls.

Don't automate a process because you can. Improve it because you should.