COMPUTER SYSTEM FOR MANUFACTURING

PROCESS AND QUALITY SYSTEM

COMPUTER SOFTWARE USED IN RPP

ERP (MFG/Pro)
eQMS : Electronic Quality
Management System

eQMS
Supported data

LIMS
LIMS : Laboratory
Information
Management System

MES
MES : Manufacturing
Execution System

BAS
PLC: Programmable
Logical Control (EQ/INS)

SCADA

PLC

SCADA: Supervisory Control

and Data Acquisition
(PW System)

MANUFACTURING PROCESS

MANUFACTURING PROCESS

MANUFACTURING PROCESS

MANUFACTURING PROCESS

MANUFACTURING PROCESS

MANUFACTURING PROCESS
>> NOW <<

>> PAST <<

EBR Take out material

LIMS

LIMS

LIMS

eQMS

eQMS Quality event record

Quality Management System

Prior Change to be occur.
Any Deviation occur in unit operation.
Record the deviation
report and inform QA

QC

OOS is occur
Record the OOS
report and inform QA
Lab investigation

Investigation
Training should be performed
periodically.

Cross functional team meeting

based on Risk Assessment Approach

OOS valid

NCR

CAPA

Recall

GOOD PRACTICES FOR DATA MANAGEMENT

AND INTEGRITY IN REGULATED (DRAFT)

PURPOSE OF GUIDE
Providing guidance for inspectorates in the
interpretation of GMP/GDP requirements in relation to
data integrity and the conduct of inspections.
The principles of data integrity apply equally to both
manual and computerized systems and should not
place any restraint upon the development or
adoption of new concepts or technologies.
In accordance with ICH Q10 principles, this guide
should facilitate the adoption of innovative
technologies through continual improvement.

GOOD PRACTICES FOR DATA MANAGEMENT

AND INTEGRITY IN REGULATED (DRAFT)

Good Data Management Practice influence the

integrity of all data generated an recorded by a
manufacturer and these practices should ensure that
data is accurate, complete and reliable.
Good Documentation Practices (GDocPs) are key to
ensuring data integrity, and a fundamental part of a
well designed Pharmaceutical Quality Management
System.

GOOD PRACTICES FOR DATA MANAGEMENT

AND INTEGRITY IN REGULATED (DRAFT)

The effective management of paper based documents is a key

element of GMP/GDP.
Accordingly the documentation system should be designed to
meet GMP/GDP requirements and ensure that documents and
records are effectively controlled to maintain their integrity.

Paper records must be controlled and must remain

attributable, legible, indelible/durable,
contemporaneous, original and accurate (ALCOA)
throughout the data lifecycle.

GOOD PRACTICES FOR DATA

MANAGEMENT AND INTEGRITY IN
REGULATED (DRAFT)

Why is managing and controlling master records

necessary?
Managing and controlling master records is necessary to ensure that
the risk of someone inappropriately using and/or falsifying a record
by ordinary means (i.e. not requiring the use of specialist fraud skills)
is reduced to an acceptable level.

The following expectations should be implemented using a quality risk

management approach, considering the risk and criticality of data
recorded

GOOD PRACTICES FOR DATA MANAGEMENT

AND INTEGRITY IN REGULATED (DRAFT)

Use and control of records within production areas

Records should be appropriately controlled in the production areas
by designated persons or processes.
These controls should be carried out to minimize the risk of
damage or loss of the records and ensure data integrity. Where
necessary, measures must be taken to protect records from being
soiled (e.g. getting wet or stained by materials, etc).

FUTURE TREND
Electronic Document Management

Increase efficiency
Automated revision control
Increased visibility
Increased Audit preparedness
Metadata Linked to Document