Validation of MES and Manufacturing

Automation systems

The FDA Group Presentation

APRIL 26, 2017
Chinmoy Roy, B.S. (Hons.) MSCS
Industry Consultant

The FDA Group | (508) 926-8330 1

Agenda

 What is a MES
 Validation concepts
 Validation’s life cycle approach
 User Requirements Specifications (URS)

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What is Validation

MES: BASIC CONCEPTS

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Production-Integrated enterprise

Manufacturing Automation system architectures

that will serve as enablers to an integrated family
of systems for automated planning, dynamic
scheduling and fully optimized production
processes to control unit production cost

Such an architecture should also reduce the

‘cyber attack surface area’ of the business

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Manufacturing automation system

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 Control Hierarchy

Level 0: Field instrument/sensing layer

Level 1: Process control layer: PLCs,, SLCs

Level 2: Process management: DCS, MCS

Level 3: Manufacturing management: MES, LIMS

Level 4: Production management, ERP

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What is an MES

 MES = Manufacturing Execution System

 Receives vast quantities of data from other
levels
 Converts to useful information
 Scheduling
 Materials management
 Quality samples

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ERP MES CONTROLS

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MES FUNCTIONS
Material Planning

Organization
Finite
Dispensing Maintenance
Scheduling
Management

Container
Handling

Production Personnel
Management
Warehousing Training

Material Material Checklist

Management Flow Management

Documentation
KPI Line
Monitoring Monitoring EBR

Data Data Batch

X’fer Collection Recipes

Plant Operation

Courtesy: Guy Wingate

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What is Validation

VALIDATION: BASIC CONCEPTS

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What is Validation

FDA has defined Validation as:

“Establishing documented evidence which
provides a high degree of assurance that a
specific manufacturing process will
consistently perform to produce a product
meeting its pre-determined specifications
and quality attributes”

Key words:
 “Documented evidence”
 “Pre-determined specifications”
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Qualification and Validation

Qualify an installation
Establish documented evidence of what hardware and software
is installed to include make, model, version number, serial
number, description of components, environmental conditions,
location etc.

Validate a function
Establish documented evidence that a software along with the
installed hardware, performs the function that it has been designed
to perform

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Challenges of CSV

 Poorly defined requirements

 Unrealistic schedule

 Inadequate testing

 Requirements creep/change

 Miscommunication during design and

development

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Challenges of CSV

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What is Validation

LIfE CyCLE APPrOACh TO

VALIDATION

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Phases: The V-model (cradle to grave)

Design Validate Operate Retire

Plan /Build
URB, Operational
System Retirement
Monitoring, Plan
Boundary SOPs
SIA
Change
Control
URS PQ
Validates Revalidation
& Periodic
Review
FS OQ
Discrepancy
Managemen
t
DS IQ
Maintenanc
e Calibration
Program

Build
Verification Validation
Did we build the right system? Did we build the system right?
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 CSV Activities - sequencing
Specification
Planning & Design

PV Plan
RMP Test
Plans IQ, OQ,
Approve Qual. Tests
Supplier FAT (IQ &
VPP URS Planning
QP OQ part.)
docs Develop
HDD
Hardware
Vendor FRS

Verification
Audit Develop
SDS
Software

SOP
PV
Access Business Validation SAT (IQ &
Retirement Security Continuity Report OQ )
Plan Backup & Disaster
Restore Recovery
LEGEND:
User Developed
Acceptance
Vendor Developed & Release

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CSV Governance documents

Ensure CSV Governance documentation systems are in place

Quality Manual

Quality Policy

Quality Standard

VMP, SOPs etc.

Vendor Personnel Change Access

Management Training Control Security

Backup &
Recovery
Document Change
Management Management

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Documents/deliverables of CSV

VPP

Plans Req.& Design Test Test Results Reports SOPs

Project Plan DDS PV Test Dev.

Test Plan FRS OQScripts
Test Resolution
PV Test
Vendor Audit URS IQScripts
Plan
Test OQResults
Test VSR
Scripts Training
RMP
Commissioning IQResults
Test Records DR
Test Scripts Results
Validation Commissioning Access
RTTM
Project Plan Test Results Sec.
BC
(VPP) RMR
RCS BR
PV: Performance Validation
OQ: Operational Qualification SLA
VPP: Validation Project Plan
RMP: Risk Management Plan
IQ: Installation Qualification Re-
URS: User Requirement Specs Validation
SDD: Software Design Description VSR: Validation Summary Report
SOP: Standard Operating Procedure.
FRS: Functional Requirement Specs. RTTM: Requirements to Test Trace Matrix
URS: User Requirement Specs. RMR: Risk Management Report
RCS: Risk Control Strategy
URS: User Requirement Specs.
SLA: Service Level Agreement
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ASTM E2500-07 process

Product GOOD ENGINEERING PRACTICE

Knowledge

Process
Knowledge
Specification Qualification Acceptance
Requirements And and Operation
Regulatory &
Design Validation Release
Requirement
Company
Quality
RISK MANAGEMENT
Requirement
DESIGN REVIEW

CHANGE MANAGEMENT

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The Validation stages

 Validation Plan

 Installation Qualification (IQ)

 Operational Qualification (OQ)

 Performance Qualification (PQ)

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What is Validation

USEr rEqUIrEMENTS SPECIfICATION

(UrS)

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What is a URS

 Document that defines clearly and precisely what the

regulated company wants the system to do and state any
constraints
 State requirements in simple language and avoid any
technical terms
 Should be platform independent and state the “What”
instead of the “How”
 It serves as a root document for Validation and testing
 It is a live document and hence is subject to continuous
update to reflect changes in requirement
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Why is a URS important

 URS is a key CSV document and is frequently audited

 Poorly written URS is one of the top 10 citations

 The URS is used as the root document to develop a road

map for the design and project deliverables.

 Being involved in the requirements definition phase will

streamline the project later on

 Helps fast track testing if URS is short, concise, testable

and traceable

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What should URS contain

1. Operational requirements 8. Availability requirements

2. Functional requirements 9. Security requirements

3. System requirements 10.Maintenance requirements

4. Data requirements 11.Regulatory requirements

5. Interface requirements 12.Migration requirements

6. Environment requirements 13.Constraints to be observed

7. Performance requirements 14.Life cycle requirements

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Typical contents of a URS

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Requirements to Test Trace Matrix
(RTTM)

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What is Validation

CASE STUDy

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URS for CASE STUDY

 Modification traceability
Use of secure, computer-generated, time stamped audit trails to
independently record the date and time of operator entries and
actions that create, modify, or delete electronic records. Record
changes shall not obscure previously recorded information.

They must be legible and exportable on a standard PC. It is

necessary to record unsuccessful access attempts by an authorized
user.

Consideration should be given , based on a risk assessment, to

building into the system the creation of a record of all GMP-relevant
changes and deletions (a system generated “audit trail”). For change
or deletion of GMP-related data, the reason should be documented.
Audit trails need to be available and convertible to a generally
intelligible form and regularly reviewed
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What are resources for Validation

The FDA Group is a global leader in GxP auditing,

remediation, and quality system resourcing.
We utilize a proprietary talent selection process of
former FDA & industry professionals, amplified by a
corporate culture of responsiveness and execution.
Headquartered in Westborough, Massachusetts, The
FDA Group has more than 355 specialists (60 of
whom are former FDA Investigators) across 42
states.

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 QUESTIONS?

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 Thank You
Contact the experts at The FDA Group

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The FDA Group | (508) 926-8330