RapidFacto
ISO 13485Document controlCAPA

Quality management system (QMS)

Document control, records, CAPA, training, internal audit, logbooks, complaints, and management review.

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

Document Control Procedure

SOP-005 · v1.4 · released

Released

Approval workflow

  1. Author

    Priya Sharma

    Submitted v1.4

  2. QA Review

    Dr. Mehta

    Review approved

  3. ReleaseSigned

    Quality Head

    21 CFR Part 11 e-sign

    e-signature · 21 CFR Part 11

    A. Kapoor

  4. Effective

    Document control

    Publish to QMS

Linked records

CAPA-047Linked deviation recordTRN-008Training auto-assigned

A QMS is more than file storage. RapidFacto manages the full quality management lifecycle — controlled documents and records, corrective actions, competency tracking, internal audits, equipment logbooks, customer complaints, and management review — all linked to manufacturing and batch data when issues touch production.

ISO 13485 without the shared drive

  • Pass document control audits with version history and obsolete removal
  • Close CAPAs with linked evidence — not orphaned spreadsheets
  • Retrain automatically when SOP revisions go effective
app.rapidfacto.com / qms / documents / SOP-005

Document Control Procedure

SOP-005 · v1.4 · released

Released

Approval workflow

  1. Author

    Priya Sharma

    Submitted v1.4

  2. QA Review

    Dr. Mehta

    Review approved

  3. ReleaseSigned

    Quality Head

    21 CFR Part 11 e-sign

    e-signature · 21 CFR Part 11

    A. Kapoor

  4. Effective

    Document control

    Publish to QMS

Linked records

CAPA-047Linked deviation recordTRN-008Training auto-assigned

Capabilities

What your team uses in RapidFacto — illustrated from the live product.

app.rapidfacto.com / documents / SOP-005

SOP-005

v1.4 Effective
DraftReviewApprovedEffective

Document Control Procedure · PDF attached

Doc control

Document control

Version-controlled SOPs and policies — draft, review, approve, release, and obsolete with full history.

  • Document types, numbering, and revision control
  • Approval workflow before effective date
  • Obsolete document removal from active use
  • Download controlled copies with audit trail
app.rapidfacto.com / records

Quality Records

Controlled

FRM-QA-012 · Batch release log

Rev 2 · Effective 01-Jan-2026

Records

Records management

Controlled quality records and forms — separate from SOPs, with the same approval rigor.

  • Record types and retention in the QMS
  • Version and approval like documents
  • Linked to CAPA, audits, and training
app.rapidfacto.com / capa / CAPA-047

CAPA-047

Action phase

Root cause: Calibration drift

2 actions open · Due 15 Jun
CAPA

CAPA

From deviation or audit finding through root cause, corrective action, and effectiveness check.

  • CAPA initiation from complaints, audits, or manual
  • Action items with owners and due dates
  • Effectiveness verification before closure
  • Approval workflow on CAPA closure
app.rapidfacto.com / training

Training

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

Training management

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

  • Training assignments when SOPs go effective
  • Completion records per employee
  • Expiry alerts before competency gaps
app.rapidfacto.com / audit

Internal Audit 2026-Q1

2 findings

Checklist 80% complete

Audit

Internal audit

Audit templates, scheduled instances, findings, and follow-up tracked to closure.

  • Audit checklists and scoring
  • Findings linked to CAPA where needed
  • Audit reports for management review
app.rapidfacto.com / logbooks

EO Sterilizer Log

Today

Cycle #142 · Operator: Rahul M.

Cleaning verified ✓

Equipment

Equipment logbooks

Usage, cleaning, and calibration logs tied to equipment IDs used in production.

  • Logbook templates per equipment type
  • Entries with timestamps and operators
  • Linked to machines in manufacturing
app.rapidfacto.com / complaints / CMP-2025-012

Packaging seal failure · Stent delivery system

ISO 13485 · 8.2.2 · Batch BMR-2025-041

CriticalReportable

Complaint workflow

  • Complaint received

    Customer · device malfunction

  • Investigation

    Assigned to QA · due 5 days

  • Root cause analysis

    Seal integrity failure identified

  • CAPA linked

    CAPA-051 · corrective action open

  • 5

    Regulatory report

    CDSCO vigilance · reportable event

    CDSCO

Linked to QMS

CAPA-051 · SOP-012

Traceable
Post-market

Complaints & surveillance

Customer complaint intake, investigation, and linkage to CAPA or batch records.

  • Complaint registration and classification
  • Investigation workflow and responses
  • Trend visibility for management review
app.rapidfacto.com / mrm

MRM Mar 2026

Closed
5 inputs · 3 actions · Management sign-off recorded
Review

Management review (MRM)

Management review meeting records with inputs from quality, production, and CAPA metrics.

  • MRM records with attendees and decisions
  • Action items from management review
  • Evidence pack for ISO 13485 clause 5.6

Approvals in QMS

app.rapidfacto.com / approval/instances

Pending Approvals

4 items

SOP-005 v1.4

CAPA-047 closure

DOC-012 release

Workflows

Pending approvals

One inbox for document releases, CAPA closures, and other QMS sign-offs.

  • Pending Approvals under QMS menu
  • Role-based steps — not named individuals only
app.rapidfacto.com / qms / documents / SOP-005

Document Control Procedure

SOP-005 · v1.4 · released

Released

Approval workflow

  1. Author

    Priya Sharma

    Submitted v1.4

  2. QA Review

    Dr. Mehta

    Review approved

  3. ReleaseSigned

    Quality Head

    21 CFR Part 11 e-sign

    e-signature · 21 CFR Part 11

    A. Kapoor

  4. Effective

    Document control

    Publish to QMS

Linked records

CAPA-047Linked deviation recordTRN-008Training auto-assigned
Setup

Approval roles & workflows

Configure who can approve what — document author, QA review, quality head release.

  • Approval roles mapped to system users
  • Workflow templates per process type

Explore other modules

ManufacturingQuality controlPurchaseStores & inventoryQMSApprovalsReports & compliance

Approvals

Role-based multi-stage approval workflows with 21 CFR Part 11 e-signatures for medical device manufacturers.

Manufacturing

Digital batch manufacturing records, IPQC, finished good testing, and batch release for medical device manufacturers — ISO 13485 and CDSCO audit-ready.

Reports & compliance

20+ automated PDF reports — BMR, COA, inspection reports, purchase orders — with full audit trail for medical device manufacturers.

See your QMS workflows live

Book a 30-minute demo. We'll walk through qms workflows mapped to how your team works today.