RapidFacto

Change control

Record why it changed, get it approved, issue the new revision, and retrain the people who use it.

View pricing
app.rapidfacto.com / documents / SOP-005

SOP-005

v1.4 Effective
DraftReviewApprovedEffective

Document Control Procedure · PDF attached

Manufacturers using RapidFacto

Trusted by 30+ medical device manufacturers

  • J Mitra & Bros
  • Dentmark
  • Adlisc
  • Aminov Medical Devices
  • Sigma International

Replacing a file is not a change. RapidFacto treats a revision as a controlled event — reason, review, issue — then assigns training so the floor is not working off the old copy.

A revision is a change, not a file replace

  • Every live SOP has a reason and an approval behind it
  • People are trained on the revision in use
  • Auditors can follow a change without a side spreadsheet
app.rapidfacto.com / documents / SOP-005

SOP-005

v1.4 Effective
DraftReviewApprovedEffective

Document Control Procedure · PDF attached

Capabilities

What your team uses in RapidFacto

Illustrated from the live product — each module below stands on its own.

app.rapidfacto.com / documents / SOP-005

SOP-005

v1.4 Effective
DraftReviewApprovedEffective

Document Control Procedure · PDF attached

Change

Revise, review, and issue

A document change is a controlled revision — reason, review, approve, then issue the new effective copy.

  • Record why the SOP or process is changing
  • Same approval path as any controlled document
  • Obsolete the previous revision on issue
app.rapidfacto.com / training

Training

3 overdue
SOP-PROD-008Complete
SOP-QC-014Due in 5d

Retrain

Training follows the new revision

When the document goes effective, assign training so the floor is not working off the old copy.

  • Assignments when a revision becomes effective
  • Completion against the current SOP revision
  • History of who trained on which rev

Explore other modules

Design controlsDocumentsChange controlCAPATrainingAuditsRisksSuppliersComplaints & PMSQMSManufacturingQuality controlPurchaseStores & inventoryApprovalsReports & compliance

Documents

ISO 13485 document control — versioned SOPs, review, approval, issue, and obsolete copies for medical device manufacturers.

Training

Training modules linked to SOPs — assign, complete, and track expiry for competency evidence on the shop floor.

QMS

ISO 13485 QMS software — document control, CAPA, training, internal audit, logbooks, complaints, and management review for medical device manufacturers.