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- Pharmaceuticals QMS
- Who it's for
- Pharmaceutical quality assurance teams
Pharmaceutical quality assurance teams
A quality assurance team often reviews work created by several people. Audits carry a scope, date, status and Auditor; findings carry the requirement, severity, Owner and due date. Controlled Documents identify the version and effective date of a procedure, while Training Acknowledgments show which Person acknowledged that document. These records give the team distinct places to look for audit follow-up and document history.
How Pharmaceuticals QMS is set up for you
Audit planning
Assign an Auditor and define the scope before findings are recorded.
Finding ownership
Give each finding a requirement, severity, owner and due date so follow-up can continue after the audit report.
Document decision
Review the attachment and version before setting a controlled document to approved.
Acknowledgment
Record the person and date against the exact document version that was read.
A quality assurance team often reviews work created by several people. Audits carry a scope, date, status and Auditor; findings carry the requirement, severity, Owner and due date. Controlled Documents identify the version and effective date of a procedure, while Training Acknowledgments show which Person acknowledged that document. These records give the team distinct places to look for audit follow-up and document history.
Start with one planned audit and one controlled procedure. Create a major finding tied to a specific requirement, assign a People owner and give it a due date. Move the audit to reporting, then ask a Quality Reviewer to locate the finding in the due list. The finding should remain visible if the audit status later becomes closed. The finding's own closure date records its follow-up separately.
Prepare a controlled document version with an attachment and effective date. After review, record one person's acknowledgment and check the history by document. Create a revised version and ask the Document Controller to distinguish the old acknowledgment from the new version. This gives the Auditor a concrete way to inspect what was approved and who acknowledged it, without assuming that a document file alone proves a person's receipt.
Features to start with
Audits
Plan audit scope, assign an auditor and follow findings through their owners and due dates.
Documents and Training
Maintain controlled document versions and trace who acknowledged each version.
Inspections
Plan assigned inspections, capture check evidence and hand completed work to quality review.
Roles on the team
- Admin
- Maintains people, users and access for the quality workspace.
- Quality Reviewer
- Reviews inspection evidence and verifies corrective action effectiveness independently of the owner.
- Auditor
- Plans audits and records findings with assigned owners and due dates.
- Document Controller
- Maintains controlled document versions and follows acknowledgments.
Set up Pharmaceuticals QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.