Form Name CAPA Plan

Note : Text in Red Bold - Mandatory Attribute

Text in Blue Bold - Conditionally Mandatory
Text in Black - Non Mandatory
Multiple values in MLOV fields should be mentioned using '|' separator
Instructions

Column Name Mandatory Data Type

General

CAPA Plan Workflow ID Yes Unique Key for the batch of upload
CAPA Plan Short Description Yes Free Text
CAPA Plan Source Yes Drop Down
Divisional Sub Unit No MLOV
Client Yes SLOV
Sub-Client No SLOV
CAPA Plan Manager Yes SLOV
Details
Issue Description Yes Free Text
Root Cause Summary Yes Free Text

Root Cause Classification Level 1 No Drop Down

Root Cause Classification Level 2 No Drop Down

Summary of Completed Immediate
Actions No Free Text
Impacted Sites No MLOV
Action Planning
Summary of Planned Actions No Free Text
Effectiveness Check Required? No Drop Down
Effectiveness Check Measure No Free Text
Justification for not Performing an
Effectiveness Check Conditional Free Text

Effectiveness Check Due Date(in

Months After Implementation) No Number
Material Data Section
Software Version Number No Free Text
Firmware Version Number No Free Text
Catalog Number No Free Text
Basic UDI-UI No Free Text
Unit of Use-DI No Free Text
Global Medical Device Number No Free Text
SGTIN No Free Text

Create CAPA Action

CAPA Plan Workflow ID Yes Unique Key for the batch of upload

Action ID Yes Unique Key for the batch of upload

Action Short Description yes Free Text
Action Type No Drop Down
Action Category Level 1 No Drop Down
Action Category Level 2 No Drop Down
Action Description Yes Free Text
Client Yes SLOV
Sub-Client Conditional SLOV
Action Owner Agreement Required? No Drop Down
Action Execution Responsibility No Drop Down
Third Party CAPA Number Conditional Free Text
Action Owner No SLOV
QA Approver No SLOV
Manufacturing Site No SLOV
Production Line / Area No Free Text
Date
Action Implementation Due Date No Format: YYYY-MM-DD
Date
Final QA Approval Due Date No Format: YYYY-MM-DD

Assign Existing CAPA Action

CAPA Plan Workflow ID Yes Unique Key for the batch of upload

Action ID
Yes Unique Key for the batch of upload
Material Data Section
CAPA Plan Workflow ID Yes Unique Key for the batch of upload

Material Data Section ID Yes Unique Key for the batch

Material Upload Type Yes Dropdown
Source Yes Dropdown
Material # Yes Free Text
Batch# No Free Text
Unknown Batch# No Dropdown
Serial# No Free Text
Unknown Serial# No Dropdown
Bulk Batch Section

CAPA Plan Workflow ID Yes Unique Key for the batch of upload

Material Data Section ID Yes Unique Key for the batch

Bulk Batch Section ID Yes Unique Key for the batch

Source Yes Dropdown
Bulk Material# No Free Text
Bulk Material Short Description No Free Text
Bulk Batch# No Free Text

Relationships

CAPA Plan Workflow ID Yes Unique Key for the batch of upload
Source Type Yes Drop Down
Source ID Yes Free Text
Comments No Free Text
Attachments

CAPA Plan Workflow ID Yes Unique Key for the batch of upload

CAPA Action ID

Yes Unique Key for the batch of upload

Source Type Yes Drop Down
File Name Yes Free Text
Description No Free Text

Tab- Header Information CAPA Header-Details

Field Title CAPA Plan Source Root Cause Classification Level 1
Audit / Inspection Environment
CMS Update Equipment
Compliance Assessment Human
PMS / Risk Management Material
PQR / APR Method
Process Improvement / OEOTHER
Process Verification (CPV, OPV)
QMR
Qualification
Regulation / Guideline
an
Mandatory Attribute
tionally Mandatory
n Mandatory
be mentioned using '|' separator

Max field length Additional Details

Unique key input that should be entered

for the batch of upload. This ID should
be used as reference in the tabs for
255 Char entering details w.r.t CAPA Plan record.
60 Char

2000 Char
2000 Char

2000 Char

4000 Char

1000 Char

1000 Char

10 Char

40 Char
50 Char
50 Char
50 Char
50 Char
50 Char
62 Char

Input for this field should be referenced

from CAPA Plan Workflow ID (unique
key) as mentioned in the CAPA Header
255 Char Tab

Unique key input that should be entered

for the batch of upload. This ID should
be used as reference in all the tabs for
255 Char entering details w.r.t CAPA Actions.
60 Char

4000 Char

100 Char

100 Char

Input for this field should be referenced

from CAPA Plan Workflow ID (unique
key) as mentioned in the CAPA Header
255 Char Tab

Mention the system generated ID for

the existing CAPA Actions in the
255 Char application
 Input for this field should be referenced
from CAPA Plan Workflow ID (unique
key) as mentioned in the CAPA Header
255 Char Tab

Unique key input should be entered for

the batch of upload. This ID should be
used as reference in the tabs for
entering details w.r.t Material Data
255 Char record

24 char
10 char

18 char

Input for this field should be referenced

from CAPA Plan Workflow ID (unique
key) as mentioned in the CAPA Header
255 Char Tab

Unique key input should be entered for

the batch of upload. This ID should be
used as reference in the tabs for
entering details w.r.t Material Data
255 Char record

Unique key input should be entered for

the batch of upload. This ID should be
used as reference in the tabs for
255 Char entering details w.r.t Bulk batch.

24 char
40 char
10 char

Input for this field should be referenced

from CAPA Plan Workflow ID (unique
key) as mentioned in the CAPA Header
255 Char Tab

255 Char
250 Char
 Input for this field should be referenced
from CAPA Plan Workflow ID (unique
key) as mentioned in the CAPA Header
255 Char Tab

Input for this field should be referenced

from CAPA Action ID (unique key) as
mentioned in the Create CAPA Actions
255 Char Tab

250 Char

CAPA Header-Details CAPA Header-Action Planning

Root Cause Classification Level 2 Effectiveness Check Required? Action Type
Decision Yes Correction
Design & Specification No Corrective Action
Design & Specification/Definition Other Action
Execution Preventive Action
Inappropriate Material
Infrastructure
Installation & Use
Knowledge / Expertise (Capability)
Maintenance
Material Handling
Misconduct
Natural events
Organization (Management System)
Specification Validation
Standards / Procedures
Work environment
none
 Drop Downs for all the Form Fields
Create CAPA Action - Action Details
Action Category Level 1 Action Owner Agreement RequirAction Execution Responsibility
Documentation Yes Bayer
Equipment / Machine No Third Party
Material
Notification
Personnel
Scrap / Rejection
Audit / Inspection
Environment
Investigation / Statement
Method
Other
Process
Recall
Software
 Material Data Section
Material Upload Type Source Unknown Batch#
Select Batch # or Serial # Manual Yes
Select Material and Add Batch # Library No
Select Material and Add Serial #
 Bulk Batch Section Relationships Attachments
Unknown Serial# Source Source Type Source Type
Yes Manual CAPA Plan CAPA Plan
No Library Complaints CAPA Action
Deviation
Event
 General
CAPA Plan Workflow ID CAPA Plan Short Description CAPA Plan Source Divisional Sub Unit
1 Raghu Compliance Assessment
ral
Client Sub-Client CAPA Plan Manager Issue Description Root Cause Summary
Germany May 16 CAPA_Manager aa bb
 Details
Root Cause Classification Level 1 Root Cause Classification Level 2
Environment Natural events
Summary of Completed Immediate Actions Impacted Sites Summary of Planned Actions
 Action Planning
Effectiveness Check Required? Effectiveness Check Measure
 Action Planning
Justification for not Performing an Effectiveness Check
Effectiveness Check Due Date(in Months After Implementation) Software Version Number
 Material Data Section
Firmware Version Number Catalog Number Basic UDI-DI Unit of Use-DI
Global Medical Device Number SGTIN
CAPA Plan Workflow ID Action ID Action Short Description Action Type
Action Category Level 1 Action Category Level 2 Action Description Client
Sub-Client Action Owner Agreement Required? Action Execution Responsibility
Third Party CAPA Number Action Owner QA Approver Manufacturing Site
Production Line / Area Action Implementation Due Date Final QA Approval Due Date
CAPA Plan Workflow ID Action ID
 Material Data Section

CAPA Plan Workflow ID Material Data Section ID Material Upload Type

Material Data Section

Source Material# Batch# Unknown Batch# Serial#

Unknown Serial#
 Bulk Batch Section

CAPA Plan Workflow ID Material Data Section ID Bulk Batch Section ID Source
Section
Bulk Material Short
Bulk Material# Description Bulk Batch#
CAPA Plan Workflow ID Source Type Source ID Comments
CAPA Plan Workflow ID CAPA Action ID Source Type File Name Description