A worker measuring a machined steel part with a digital caliper at a bench

Quality & Compliance

Validation & Qualification

Prove the equipment and the process are fit. Block work when they are not.

Hans Westbeek / Unsplash

Validation proves that a machine, a utility, a process or a cleaning procedure is fit for use. It then warns or blocks work when that proof expires. The pharma stage names are DQ, IQ, OQ and PQ: the design is right on paper, the equipment is installed as designed, it works across its range, and it works with the real product. The names are a list the plant can rename, so a food plant does not have to use the pharma words.

Each subject gets one register entry with its stages and its expiry in view. The engineer starts the record, uploads the executed protocol and writes down any deviation. A different person approves. Stages run in order, so the system refuses to approve OQ while IQ is not approved. Every uploaded file is fingerprinted and locks on approval. Cleaning limits are computed by the server from the equipment group and the swab points. A typed limit is an audit risk.

The gate strength is set per machine: off, warn, or block. Set to block, a lapsed qualification stops the work order before the machine runs. A change raises one question, whether revalidation is needed, and a yes creates the work. A critical change can suspend the affected machines at once. What the platform is responsible for is the signature, the audit trail and keeping the person who executes apart from the person who approves. Compliance itself remains the customer's validated system and their own procedures.

A worker measuring a machined steel part with a digital caliper at a bench

Who uses it

PersonWhat they do here
Validation ManagerOwns the register, plans the work and runs change control.
Validation EngineerExecutes the work, uploads the signed protocol and records deviations.
QA ApproverApproves, returns or rejects, and releases a suspended machine.
Process EngineerRuns the process-validation campaign.
Hygiene LeadOwns the cleaning validation.
Production ManagerSees why a machine is blocked and what it needs.

Today vs Phasis

Today
With Phasis
Qualification status lives in a binder and a calendar reminder.
One register per subject, with stages and expiry visible.
A lapsed qualification is found during an audit.
The gate warns or blocks the work order before the machine runs.
An approved protocol file can be swapped.
Every file is fingerprinted and locks on approval.
Cleaning limits are typed into a spreadsheet.
The server computes the limits.
A change is assessed in an email thread.
Change control records whether revalidation is needed and creates the tasks.

What you get

  • Most systems describe qualification status. This one can block the work order.
  • The gate strength is set per machine: off, warn, or block.
  • Stages run in order, so the system refuses to approve OQ while IQ is not approved.
  • A change asks one question: does this need revalidation? A yes creates the work.
  • Cleaning limits are calculated rather than typed, because a typed number is an audit risk.
  • Ongoing process monitoring hands over to In-Process & SPC, statistical process control.

See it on your own plant.

Thirty minutes with an engineer. We walk the modules you care about against your own lines and shifts.

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