MES and Data Integrity - allyoucantrackandtrace.comEsisoft).pdf · Author: Alberto Rossi Subject: Rockwell Automation Keywords: Rockwell Automation Created Date: 5/8/2016 5:08:02

Copyright © 2016 Rockwell Automation, Inc. All Rights Reserved.PUBLIC

PUBLIC

PUBLIC - 5058-CO900H

MES and Data Integrity

May 12th, 2016

Alberto Rossi

Sr. Business Consultant LS

Rockwell Automation

Email: [email protected]

mailto:[email protected]


Importance of Data IntegrityImportance of Data Integrity

Agenda

2

What is MES?

How an MES can help?

Conclusions


Data Integrity: why is it important?

Lack of integrity undermines the

assurance and confidence in a drug’s

safety, efficacy and quality

Data integrity problems break trust

Data integrity problems can severely

impact your business

3

Submitting false data to the FDA is a criminal violation under

FD&C Act (CGMP /adulteration provisions) Title 18 U.S. Code -

various sections


Is it anything new?

4

21 CFR Part 11 (2003)

PIC/S Guidance “Good

Practices for computerized

systems in regulated “GXP”

environments” (2007)

GMP EU, Chapter 4 (2011)

GMP EU, Annex 11 (2011)

“Data Integrity and Compliance with CGMP”, draft, FDA, April (2016)


ALCOA = Data Integrity Unit of Measure

A – attributable to the person generating the data

L – legible and permanent

C – contemporaneous

O – original (or ‘true copy’)

A – accurate

5

FDA’s Data Integrity Focus


Impact on Data Integrity

6

Violation of data integrity

Fraud

non fare le cose quando

andrebbero fatte

fare le cose quando non

andrebbero fatte


What is MES?

Importance of Data Integrity

What is MES?

Agenda

7


Conclusions


MES: Classification

8

Level 2 SCADA

Level 4 ERP

Level 3Level 3 MES


S95 Perspective: Data View

9

Level 2 SCADA

Level 3 MES

Level 4 ERPMaterial

OrdersInventory

…

Orders

Material

Inventory

…Recipes

EquipmentUser

ParameterRecipes …

Dat

aD

ata

Data

Data


Pursuing Data Integrity

Define Master system to avoid data conflict.

A master system should be defined for every data type.

Define raw data

Raw data is relevant for product quality

They should be “risk-based”.

10




«Risk based» approach

11

Data

IntegrityProduct

QualityPatient

Safety

foundation of the «risk based» approach


Pursuing Data Integrity



Define raw data

Raw data is relevant for product quality

They should be “risk-based”.

Design your systems in a way that encourages compliance with the

principles of data integrity.

12


Rules for an MES…

The MES development for the pharmaceutical industry follows

Good Engineering Practices

Good Testing Practices

Good Documentation Practices

Valid regulations are taken into account and respected, such as:

21 CFR Part 210, 211, 11

EudraLex Vol. 4 (with focus on Annex 11)

ICH Q9

…

13

By the way: a validated MES can replace the “witness”!


Designing compliant systems

14

Source: MHRA GMP Data Integrity Definitions and Guidance for Industry (Rev. 1.1), March 2015MHRA = Medicines & Healthcare products Regulatory Agency (UK)

Examples include:

Access to clocks for recording timed events

Accessibility of batch records at locations where activities take

place so that ad hoc data recording and later transcription to

official records is not necessary

User access rights which prevent (or audit trail) data

amendments

Automated data capture or printers attached to equipment such

as balances

Access to raw data for staff performing data checking activities.

…



What is MES?



Agenda

15

Conclusions



16

Performance and Quality Improvements with MES: some examples

The use of a Manufacturing Execution System (MES) supports data integrity by validation measures:

1. Configurable system rights (access privileges, signatures, etc.)

2. Object status management (recipes, equipment, etc.)

3. Consistency checks (with configuration, data input, etc.)

4. Automatic recording of changes (audit trail, log, etc.)

5. Transaction concept

6. Testing and monitoring interfaces to other systems

7. …


MES in action

17


Conclusions


What is MES?


Conclusions

Agenda

18


E.g.: MES Vs Paper

A – attributable

L – legible and permanent

C – contemporaneous

O – original (or ‘true copy’)

A – accurate

19

+

++

+++

++

+++


Can MES help?

20

Copyright © 2016 Rockwell Automation, Inc. All Rights Reserved.PUBLIC 21

Alberto Rossi

Sr. Business Consultant LS

Cell.: +39 348 5248098

Email: [email protected]

Thank you!

mailto:[email protected]

MES and Data Integrity - allyoucantrackandtrace.comEsisoft).pdf · Author: Alberto Rossi Subject: Rockwell Automation Keywords: Rockwell Automation Created Date: 5/8/2016 5:08:02

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