Quality & Compliance
Validation & Qualification
Keep qualification status, evidence and approvals ready for production and audit.
Qualification records spread across binders, calendars and local files make it difficult to confirm whether equipment is ready for production. Phasis provides one current register for each subject and can warn or block a work order when a required qualification has expired.
Engineers record each stage, upload executed protocols and document deviations. Stages follow the approved sequence, a different person provides approval, and approved files are fingerprinted and locked. Plants can use familiar stage names instead of being forced into one validation vocabulary.
Change control records whether revalidation is required and creates the resulting work. A critical change can suspend affected equipment until QA releases it.
Who uses it
Validation Manager
Owns qualification registers, plans the work and manages change control.
Validation Engineer
Executes the work, uploads the signed protocol and records deviations.
QA Approver
Approves, returns or rejects, and releases a suspended machine.
Process Engineer
Runs the process-validation campaign.
Hygiene Lead
Owns the cleaning validation.
Production Manager
Sees why equipment is restricted and what is required for release.
How the process changes
- TodayQualification status is split between binders, files and calendar reminders.With PhasisOne register shows the stages, evidence and expiration for each subject.
- TodayAn expired qualification is discovered after production or during an audit.With PhasisThe production gate can warn or block the work order before the equipment runs.
- TodayAn approved protocol can be replaced without a clear record.With PhasisEvery approved file is fingerprinted and locked.
- TodayCleaning limits are calculated in an editable spreadsheet.With PhasisPhasis calculates cleaning limits consistently from the approved inputs.
- TodayRevalidation decisions are made and recorded through email.With PhasisChange control records the decision and creates the required work.
What you get
- A configurable warning or production block when a required qualification has expired.
- Independent approval that prevents the executor from approving their own work.
- Locked, fingerprinted evidence for every approved protocol.
- Change control that turns a revalidation decision into assigned work.
See how Phasis fits your operation.
Tell us which process you want to improve. We will show the relevant workflow using the lines, shifts and decisions your team handles every day.