Vendors and audits: qualified under signature

Oversight

• You can outsource the work, but not the responsibility. So every vendor has to be qualified, and checked.
• MAESTRO keeps a vendor register and an audit register, side by side.

Qualify

• A new vendor starts as prospective, not yet assessed. Record an assessment, with its method and rationale.
• Nothing changes until the decision is signed. Then the vendor becomes qualified, with a date to requalify.
• Its qualification file holds the agreements and certificates, and each night MAESTRO checks what is about to lapse.
• It warns the owner. It never disqualifies a vendor by itself.

Perform

• A scorecard measures six figures for a period. What cannot be measured shows a dash, not a zero.
• A named reviewer rates it green, amber or red. After that, the figures are fixed.

Audit

• For audits, build the year's programme, schedule each audit against it, and approve it under signature.
• Apply a checklist, and its questions are copied onto the audit. Seven starter checklists are included.
• From a non-compliant answer, raise a finding. It arrives filled with the question and the clause.
• The report is issued under signature, stored with its checksum, then filed to the trial master file.

Close

• A finding takes a response. Then you can link a CAPA, or raise a quality event.
• And Close Audit is refused while a critical or major finding has no CAPA linked.
• Preparing for an inspection? A readiness review gathers ten dated readings from across the platform, and gives no verdict.

Vendors and audits in MAESTRO: qualified under signature, and closed only when the loop is closed.