How to write an

Effective and
Robust CAPA
5 TIPS to write
SMART CAPA
swipe
Akanksha Jain - GCP Auditor
 1
SMART
S - Specific
DO NOT Create ambiguous Actions Instead
Action must specify :
WHO is responsible for the action
WHAT will be the action
HOW the action will be completed

Akanksha Jain - GCP Auditor

 2
S M ART
M - Measurable

The implementation of action must be supported

by an evidence to measure.

Which one DO you Think is a MEASURABLE Action

PI confirmed he will keep an oversight on site

members.
A PI oversight plan will be drafted per which
monthly team meeting will be conducted and
Minutes of Meeting will be recorded.

keep swiping
Akanksha Jain - GCP Auditor
SM A RT
A - ACHIEVEABLE

3
The action must be feasible to
achieve and must NOT be an
OVER-COMMITMENT.

Ask following questions - DO

we have necessary resources?
Will it involve other
departments? Is the timeframe
Realistic?

keep swiping
Akanksha Jain - GCP Auditor
SMA R T
4
R - RELEVANT
The action must be relevant & must be aligned to
mitigate the problem and root cause.

Akanksha Jain - GCP Auditor

 SMAR T
T - Timeliness
5
CAPA must be time bound . Do NOT draft action for
an indefinite time.

Which one do you think is time bound CAPA?

CRA to conduct IMV to review IP administration

documents from randomization (when can you
close this CAPA??)

CRA to conduct IMV to review IP administration

documents from randomization for next 2
subjects (Can you CAPA close after review of IP
documents from 2 subjects)

Akanksha Jain - GCP Auditor