Quality Management: each record with its proof

Your day

• Quality work is procedures, training, delegation, deviations and CAPAs. And each one needs proof.
• In MAESTRO, Quality Management keeps them together, with electronic signatures on the decisions that matter.

Documents

• Start with a controlled document. Create version two, send it to review, then approve and release.
• That one signed step retires version one, cancels its open training, and assigns version two to the roles that require it.

Training

• The Training Matrix links roles to documents. Preview who would be assigned, then apply.
• Each person reads, passes the quiz if one is required, and attests with their password.
• The compliance report shows who is current, and each person has a training transcript.

Delegation

• The delegation log records which tasks the investigator hands to each person at a site.
• The investigator signs it in MAESTRO. Or you record a signature made elsewhere, and where it is filed.
• And the register opens with a red panel: active sites with no delegation log in force.

Events

• A deviation gets a reference number, a category and an impact level. Closing it must be signed.
• Your organization can require a CAPA before a deviation of that severity closes.
• A CAPA holds its root causes, its actions, and a check that they worked. Its closure is signed too.
• Root Cause Trend then shows, quarter by quarter, which causes keep coming back.
• Documents, deviations and CAPAs are archived with a reason, never deleted. Their changes are written to the audit trail.

Quality Management in MAESTRO: documents, training and CAPAs, each with its proof.