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- Pharmaceuticals QMS
- Process
- Document and acknowledgment review
Document and acknowledgment review
Carry a controlled version through review and trace each person's acknowledgment to that version.
Step by step
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Prepare version Document Controller
Document Controller records title, version, attachment and intended effective date while the document is draft.
- Captures version and attachment
- Updates Controlled documents
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Review content Quality Reviewer
Quality Reviewer examines the version before it is approved.
- Makes the review state visible
- Updates Controlled documents
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Approve version Quality Reviewer
Quality Reviewer makes the document decision and changes its status to approved.
- Records the approved state
- Updates Controlled documents
ApprovalA person approves before the work moves on. -
Record acknowledgment Document Controller
Document Controller records the Person and date against the exact Controlled Document version.
- Ties person and date to a version
- Updates Training acknowledgments, Controlled documents, People
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Replace version Document Controller
Document Controller prepares the next version and marks the older one obsolete after the effective change.
- Preserves version-specific history
- Updates Controlled documents, Training acknowledgments
Who does what
Roles and permissions- Document Controller
- Prepares versions and records acknowledgments; Quality Reviewer decides document approval; Auditor inspects the resulting history.
Set up Pharmaceuticals QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.