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- Pharmaceuticals QMS
- Features
- Documents and Training
Documents and Training
Maintain controlled document versions and trace who acknowledged each version.
OverviewDocument review queue×
Pharmaceuticals QMS · Documents and Training
New
Document review queue
Approval conditions
| Title | Version | Effective date | Status | Document | |
|---|---|---|---|---|---|
| Draft cd-264 | Rev A | 10 Oct | Draft | DCM-931 | |
| Draft cd-621 | Rev B | 17 Oct | Draft | DCM-964 | |
| Draft cd-316 | Rev C | 24 Oct | Draft | DCM-341 | |
| Draft cd-790 | Rev D | 11 Oct | Draft | DCM-824 | |
| Draft cd-965 | Rev E | 21 Oct | Draft | DCM-758 |
6 of 6 records
Draft cd-264Controlled documents · CD-58733
DraftVersionRev A
Effective date10 Oct
DocumentDCM-931
What you can do
Connect a document version to its readers
Controlled Documents retain a title, version, effective date, attachment and status. Training Acknowledgments link a Person to a specific Controlled Document and record when the acknowledgment happened. Together they let a Document Controller answer a practical question: which version did this person acknowledge, and on what date? The reference is to the document record, so keeping version identity clear is essential when a newer version is prepared.
A document may be draft, in review, approved or obsolete. Those states help the team distinguish working content from a version intended for use. Acknowledgment history remains attached to the version the person saw. When a revision changes the effective content, use a clear version and effective date so the old and new acknowledgments can be interpreted correctly. The status should reflect the team’s actual document decision, not just the presence of an attachment.
How the work is organized
- Version control. Record a clear title and version with the document attachment and effective date.
- Review. Examine the draft and review states before an approved version is put into use.
- Acknowledgment. Link each person and date to the controlled version they received.
What to agree during setup
Agree the naming and version convention before importing documents. Define who can set a document to approved or obsolete and what review occurs before that decision. Decide how People records map to the workforce that needs to acknowledge a given version. Keep a stable title for a document family while giving each effective version a distinct version value. For an attachment supplied from a separate document system, agree how its final file is copied or connected to this record.
Set a routine for reviewing acknowledgments when a new version becomes effective. A blank acknowledgment date should remain distinguishable from a recorded acknowledgment. The team should not interpret an older version’s acknowledgment as evidence that the person received the new one.
Check the handoff on an actual case
Create a controlled procedure with a title, first version, attachment and effective date. Move it through review and approval after the designated people inspect it. Have a Person acknowledge that exact version and check that the acknowledgment history identifies both the person and document. Then create a revised version with a later effective date. Ask the Document Controller to show the two version records and explain which acknowledgment belongs to which. Mark the older version obsolete when the team’s document decision is complete.
For an audit request, find the approved version and the named person’s acknowledgment date. The reviewer should not need to infer the version from a filename or an email exchange. If the person has not acknowledged the current version, the gap should be visible in the operating review.
What your team sees
- Document review queue — Draft versions with their title, version, effective date and attachment.
- Training acknowledgment history — The person, controlled document and date of each recorded acknowledgment.
Follow the work through
Use document and acknowledgment review to check a revision against its recorded readers.
What it keeps track of
Data model- Controlled documents
- Controlled Documents records for Quality & Compliance (Source).
- Training acknowledgments
- Training Acknowledgments records for Quality & Compliance (Source).
- People
- People records for Quality & Compliance (Source).
Who uses it
Permissions- Document Controller
- Maintains versions and acknowledgment history.
- Quality Reviewer
- Reviews the quality decision on a version.
- Auditor
- Inspects the records during audit work.
Set up Pharmaceuticals QMS your way.
Start free, then use Proto to change fields, steps and approvals before your team goes live.