Crakn LLC For Quality System Implementation and Support,… GetCrakn!
QUALITY SYSTEM IMPLEMENTATION AND MAINTENANCE
AUDITS
Hosting: FDB, FDA, NB/ISO
Supplier / Vendor
CMO / OEM
Internal: Perform and Manage
Internal: Perform and Manage
Initiate / Evaluate
Root Cause / CAPA
Track / Trend
Field Return Evaluation
|
MANAGEMENT REVIEW
Develop
Plan / Organize
Present
Action Item Follow-Up
CAPA
Initiate / Evaluate
Root Cause / Effectiveness
Track / Trend
Train
|
SUPPLIER CONTROL
SCAR Implementation
Evaluate
Track Metrics / KPI’s
Perform Audits / GAP
NCR / NCMR
Initiate / Evaluate / Rework
Root Cause
Track / Trend
Quarantine
|
COMPLAINTS
Initiate / Evaluate
Root Cause / CAPA
Track / Trend
Field Return Evaluation
|
TRAINING
cGMP / GDP
ISO 13485
QSR CFR 820
|
SAFETY TRAINING
OHSA General
Protective PPE
Lockout Tag Out
BBP
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