Ignition is growing quickly in life sciences, and we expect much more of it in regulated plants over the next few years. This page covers the regulated work we have delivered and how we approach it.
For a process-equipment builder's pharmaceutical client, we built recipe management with versioning and locking, designed to 21 CFR Part 11 rules, and a batch-records system that scans each component into multi-level blend and load hierarchies, with reports tied to historian data.
Most of these requirements concern records and control rather than screens. We plan for them from the first architecture meeting.
Ignition's audit logs record who changed what and when. We configure them so the records your quality team needs are available without exporting spreadsheets.
Sign-on through your directory, with roles that limit who can approve a recipe, release a batch or change a setpoint.
Versioned recipes that lock on approval, so production runs only what quality has approved.
Components, lots and process data tied to each batch, so a deviation can be traced back to what went into the batch.
Involved from the start, so the design documents they test against exist before testing begins.
A test gateway for every change, so nothing reaches a validated system before it has passed your change-control process.
Software is not validated on its own. Your system is validated, in your plant, against your requirements. Ignition provides the functions Part 11 calls for, such as audit logs, user authentication and controlled records, and validation covers how they are configured and documented.
Yes. For a pharmaceutical client of a process-equipment builder, we built recipe management with versioning and locking, and batch records that trace each component into the blend and load it went into.
Yes. We recommend involving them from the start, so the design documents they need exist before testing begins rather than being written afterward.
Yes. A free Ignition MRI of an existing gateway, or a fixed-fee architecture blueprint for a new system, is a low-risk way to see how we work.
Call us and we'll connect you with the right engineer. If we aren't the right fit for your project, we'll tell you.
Contact us →