PLC C PDF

IIRs Computer and Software Validation Processes
July 26-28, 2000 in Washington DC
Testing
A u tom a ted M a n u facturing Processes
( PLC based architecture)
Orlando Lopez, McNeil Consumer Healthcare 1

Introduction.
Regulations.
C S V A u tom a ted M a n u facturing System s .
PLCs Validation M e thodology / Approach.
Testing.
C o n tro ls during operation.

O b jective
This session outlines item s to consider

during the testing of PLC-based autom a ted
m a n u facturing processes.

R e ferences
l O . Lpez, A Practical G u ide to Regulatory

System s H a rdw a re Q u a lification, Serentec
Press, Inc., A p ril 2000.
l O . Lpez, Qualification of SCADA System s ,
Serentec Press, Inc., M a rch 2000.
l O . Lpez, Automated Process Control System s
Verification and Validation, Pharm a c e u tical
Technology, Septem b e r 1997.
l G A M P G u ide, Validation of Autom a ted System
in Pharm a c e u tical M a n u facture, Version 3.0,
A p ril 1998.
Introduction

W h a t is an autom a ted m a n u facturing

process?
l In sim p le term s , it is the use of com p u ters to

control or m o n itor one equipment or an entire
m a n u facturing facility.
l The task may be as simple as turning off and on a
m o tor (control) in response to a switch (instrum e n t)
or taking the temperature readings every one
m inute (data acquisition) and saving the data for
future use.
l The task may be as complex as controlling an
entire m a n u facturing facility and gathering and
displaying data to facility personnel.

An exam p le of a sim p le autom a ted

m a n u facturing process

System s A rchitecture
MRP D istribution
Information
Systems
Finan- Recipe Quality * Document M a intenance

c ial Generat. LIMS System s Control Management
* Complaints,
Systems
SCADA
Process Control
Inspection,
Training, etc.
DCS
PLC PLC I/O PLC BAS
I/O I/O I/O I/O
Instrumentation / Sensors
Process
P L C C o m p o n e n ts
Operator Interface /
SCADA
PLC
Terminal Interface PLC Database
I/O s
Users program
Processor
memory
C o m m u n ication
Data Network
Interface Card

S o ftware Com p o n e n ts
l PLC softw a re, e.g., Ladder Logic.

l H M I/S C A D A -- operator interface to the
process, short term process data storage,
supervisory control (e.g. recipe management
and download) and alarm and event logging.
l Batch application -- batch automation
solution.
l Database
l O p e rating system -- e.g., W indows NT.

P L C B a s ics -- Validation Issues
I/O s.
Part 11, Supervisory Control and Data
Acquisition ( S C A D A ).
O p e rator Interface.
Program m ing (M o d u larity).

Pharm a c e u tical Manufacturing

Regulations
(sum m ary)
A u tom a ted System s

G x P R e g u lations
G M P R e g u lations that apply to CS
3 C o m p u ters.
21 CFR 211.68 Automatic, Mechanical, and
E lectronic Equipm e n t
21 CFR 820.70 (i) Automated processes
3 Hardware, classified as equipment.

21 CFR 211.63 suitable location of equipm e n t
21 CFR 211.67 m a intenance program s

G x P R e g u lations
G M P R e g u lations that apply to CS

3 S o ftware, regarded as records.
21 CFR 211.101(d) verification of records
21 CFR 211.180(a) record retention
21 CFR 211.180(c) record access
21 CFR 211.180(d) record m e d ia
21 CFR 211.180(e) record review
21 CFR 211.188(a) reproduction accuracy
21 CFR 211.188(b) (11) documentation
21 CFR 211.192 QC record review

G x P R e g u lations, cont.
G L P R e g u lations that apply to CS

3 Hardware and data recording equipment
21 CFR 58.51 specimen and data storage
21 CFR 58.61 equipment design
21 CFR 58.63 maintenance and calibration of
equipm e n t

G L P R e g u lations that apply to CS

3 S o ftware records and raw data.
21 CFR 58.33 study director responsible for raw data.
21 CFR 58.35 QA check that reports match raw data.
21 CFR 58.81 SOP for recording of deviations as raw
data.
21 CFR 58.90 animal feed and water analyses as raw
data.
21 CFR 58.185(a) report m u s t define location of raw
data.
21 CFR 58.190 raw data must be archived, retained and
secured.
21 CFR 58.195 raw data retention period.

International Conference Harm o n ization

(IC H ) GCP Regulations that apply to C S
3 E lectronic data system s
ICH 5.5.3 data system validation
3 E lectronic source data
ICH 4.9.5 source data & document retention
period
ICH 5.5.3 data security and m a n a g e m e n t

O ther Key Regulations / Guidelines
E U G M P , Annex 11 -- Computerized
System s .
G A M P (Rev 3)
CPGs

C o m p liance Policy Guidelines
I/O Checking (CPG 7132a.07).

Identification of Persons on Batch Production
and Control Records (CPG 7132a.08).
Vendor Responsibility (CPG7132a.12).
Source Code for Process Control Application
Program s (CPG 7132a.15).
C G M P A p p licability to Hardware and Software
(CPG 7132a.11).
CGMP 21 CFR Part 11: Electronic Records,
E lectronic Signatures (CPG 7153.17).

O ther Regulations
21 CFR 11 as a CSV model
21 CFR 11 Model
Validation Best Practice
Current Best Practice

Transition
Program
Current Generation of Systems New Generation of Systems

A u tom a ted M a n u facturing

System s
CSV

A u tom a ted M a n u facturing System s

Validatio n P rocess
A s y s tem a tic process to verify and test the

implementation, installation, and testing for
n e w c o m p u ter system s o r the m o d ifications to
an existing com p u ter system .
Integrated w ith the system d e v e lopm e n t
m e thodology.
Life cycle m e thodology is recom m ended by
w o rld w ide regulatory authorities.

Computerized Systems
Start Development Process End
System Development
Implementation Operation /
Phases Initiation Requirements Design Build Test
and Acceptance Maintenance Retirement
Users / Users /
Users / Users / Users /
Responsibility Developer Developer Developer IM / Eng IM / Eng
IM / Eng IM / Eng IM / Eng
Justification User Reqs. Systems Code Unit and FAT Follow SOPs Retirement
Deliverables
Document Val. Plan Design Integration FAT Summary & Plan
(if applicable) Test Demonstrate
RFP Plans & Q Protocols Compliance
RFP Response Results and
Vendor Audit Sum. Docs.
(if applicable) User Documentation
System Documentation
Training Documentation
SOPs
System
Specification Transfer to
production
plan
VSR
Release Memo
Support Log
Part 11 Include Include Build technical controls into system. Include Periodic Include
Considerations Part 11 in Part 11 in: Test technical controls. procedural review for record retention
Justification Func. Reqs, controls in Part 11 requirements in
Document System Spec, SOPs. requirements. Retirement
Val Plan, Plan
RFP, Test technical
vendor audit controls in FAT
configuration
Include Part 11
in VSR

Critical Deliverables: W h y , What, How and

When
B u s iness / Project Plan W h y the system w a s
implemented.
U s e r R e q u irem e n t s W h a t is needed to support the
operations / operators.
Functional Specification W h a t the system is supposed to
do.
D e s ign Documents, Test C h a llenges H o w it w a s d e s igned,
P lans, IQ / O Q a n d P Q specified, im p lem e n t e d a n d
tested.
R e q u irem e n ts Matrix W h a t testing is required to
confirm the users / system s
requirem e n ts and design.
C h a n g e C o n trol H o w / W h e n it w ill b e m a intained

in a validated state.

PLC
Design


C o n tro l System D esign
Piping and I/O L ist

Instrumentation
Instrument List
D iagrams.
W iring Diagram s .
Panel Drawings.
Pneum a tic Connection
D iagrams.
Instrumentation
details diagrams.

E lectrical and Instrum e n tation Design
Code and Standards. M o tors.

Control Circuit PLC.
Voltage.
External Connectors.
Grounding.
Electrical Control
E m e rgency Stop. Devices.
Fault / Alarm s C ircuit. Rack Layouts.
Operating Modes. Recom m ended supply
voltages.
M o tor Starters.
Enclosures.

PLC
(stand alone)
CSV

P L C s -- the equipm e n t / m a c h ine com e s

w ith a PLC and the PLC is stand alone
G A M P type software 2 -- M icrocontrollers.
E lectronic R a w D a ta.
PLC
I/O
Process

Sum m ary of Part 11 Require m e n ts

A p p licable PLC Systems (optional)
1 Validation
2 System Security
3 Operational Checks
4 Location Checks *
5 Document Control
6 Open/Closed Systems
7 Electronic Raw Data Protection
Note: Part 11 is applicable to electronic records and the computer
system associated with the records.

Category 2
Category Type of Software Validation Approach
2 Controllers Record configuration
l Process / Instrumentation Design

l IQ
l Instrumentation Calibration
l OQ (Black Box)
Examples: Tumbler controlled by a PLC

(controller provided by equipment manufacturer).
E lectronic Raw D a ta
Define the universe of data that will be

collected, the procedures to collect it, and
the means to verify its integrity, accuracy,
reliability and consistency.

Issues
Testing
Demonstrate that the data acquisition functions:
3accurately collecting and retrieving data;
3reading data automatically after the prescribed
period;
3operational sequencing and security;
3challenge data management, as appropriate;
challenge under routine and heaviest load scenarios;
3challenge the system response upon loss of
communication.

G M P k e y e lements
Q u a lification.
C o n figuration Managem e n t.
O n -going m o n itoring.
Periodic Reviews.
Calibration.

PLC
(connected to other equipm e n t
/ machines)
CSV

P L C s -- connected to other equipm e n t /

m a c h ines
G A M P type software 5 -- Custom B u ilt.
E lectronic R a w D a ta.
Full validation, CPG 7132a.07.
PLC
PLC PLC PLC
I/O I/O I/O
Process
Category 5
Audit supplier and validate
5 Custom Systems
complete system
l SDLC and SQA Activities

l Supplier Audit
l Extensive Verifications
l The qualifications
8 Examples:
Examples: Packaging Lines. PL
(controller connected to other PLC / I/Os).

Issues
System D e s ign
Define the universe of data that will be collected,
the procedures to collect it, and the means to
verify its integrity, accuracy, reliability and
consistency.

Issues
Testing
3accurately collecting, storing and retrieving data;
period;
3challenge data transmission to other plc network, as
appropriate; challenge under routine and heaviest
communication load scenarios;
communication.

Validation.
Periodic Reviews.
Calibration.

Relax...there are
only 900 more
slides
to go!

PLC
(linked w ith S C A D A )
CSV

P L C s -- connected to SCADA
MRP D istribution
Information
Systems
Finan- Recipe Quality * Document M a intenance

c ial Generat. LIMS System s Control Management
* Complaints,
Systems
SCADA
Process Control
Inspection,
Training, etc.
DCS
PLC PLC I/O PLC BAS
I/O I/O I/O I/O
Process
Sum m ary of Part 11 Require m e n ts

S C A D A S y s tem s (required)
1 Validation 11 Operational Checks
2 Audit Trails and Metadata 12 Authority Checks
3 System Security 13 Location Checks
4 Electronic Signature Security 14 Document Control
5 Code and Password Security 15 Open/Closed Systems
6 Code and Password Maintenance 16 Signature Manifestation
7 Electronic Password Assignment 17 Signature Purpose
8 E-Sig without Biometric/Behavioral 18 Signature Binding
9 E-Sig with Biometric/Behavioral 19 Certification to FDA
10 Record Retention/Protection

Category 4 and 5
Audit supplier, validate application
4 Configurable Software Packages
and any custom code
Configurable
l Supplier Audit
Fixed
Core
l The qualifications S h e ll
Examples: SCADA packages

Category 4 and 5
Audit supplier and validate
5 Custom Systems
complete system

l Supplier Audit
l The qualifications
Examples: Ladder logic PLC based systems

Issues
System D e s ign
Define the universe of data that will be collected,
the procedures to collect it, and the means to
verify its integrity, accuracy, reliability and
consistency.

Issues
Testing
3accurately collecting, storing and retrieving data;
period;
3challenge data transmission to other plc network, as
appropriate; challenge under routine and heaviest
communication load scenarios;
communication.

Validation.
Periodic Reviews.
Calibration.

W h a t goes into a
qualification protocol?
Testing
Factory Acceptance
Testing
S ite Acceptance Testing
Q u a lification

Testing Tim e line
Live
Install Start- Trials Operations
up
TIME
Site
Acceptance Qualification Product
FAT IQ OQ PQ Qualification
Ongoing
On-site Operation
testing

FAT and Site Acceptance, and

Q u a lification
FAT
l The focus of the FAT is the FS and the URS.
l The focus of the Site Acceptance is the
requirements contained in the DS and FS. Site Acceptance
Dont repeat field independent User
Acceptance test cases as part of Site
Acceptance testing.
Qualification
l A comprehensive Site Acceptance testing
implies not to repeat during the Qualification the Testing
testing related with DS (IQ) and FS (OQ).
l The Qualification phase can concentrate only in
testing the users requirements (PQ).

User and Site Acceptance, and

Q u a lification
l User Acceptance
It is performed by the developer of the
configurable elem e n ts at the developers site.
Test conditions are very sim ilar to the hardware
and software to be encountered in the
operational conditions.
M a in tests, based on Functional Specification:
3 Functional Testing.
3 Communication, including error detection protocol.
3 Screens Navigation/Verification.


Q u a lification
l User Acceptance
M a in tests, cont:
3 Database structure, files tables and data archiving.
3 Startup/Shutdown of the computer systems.
3 Batch Control/Reports.
3 Alarming.
3 Timing.
3 Sequencing.
3 Loss of System Power.


Q u a lification
l User Acceptance
M a in tests, cont:
3 Recipe Downloading and Saving.
3 History Tracking, Data acquisition (e.g., scan I/Os from
RTUs) and Database access controls.


Q u a lification
l S ite Acceptance
Set of activities com p rised by the system
installation, qualification of the installation,
start-up, operational testing and turnover.
Performed under operational conditions by the
integrator.
M a in Tests: H W Q u a lification:
3 Schematic drawings, P&ID, Instruments List, Loop
Diagrams, I/Os List.
3 Calibration.
3 Wiring Checks.

Q u a lification
l S ite Acceptance, cont.
M a in Tests: H W Q u a lification, cont:
3 Hardware configuration and, interface verification and
integration.
3 Physical security.
3 Built-in diagnostics (e.g., power supply, processor,
peripheral equipment, communication)
3 Interfaces.
3 Control Panel Verification.


Q u a lification

M a in Tests: S W Installation Qualification:
3 Input / Output Module Test.
3 Man-machine interface installation verification.
3 Logical security.
3 Database installation and database configuration
verification.
3 System start-up / shut-down.


Q u a lification
M a in Tests: SW Operational Qualification:
3 Recipe Downloading and Saving.
3 Catastrophic recovery verification
3 Man-machine-interface functional verification
Boundary values.
Invalid values.
Special values.
Decision point & branch conditions.
Control panel.


Q u a lification
M a in Tests: SW Operational Qualification, cont:
3 Batch Control/Reports.
3 Hardware redundancy verification.
3 History Tracking, Data acquisition and Database access
controls.
3 Trending and alarms processing.
3 Interface with other applications (e.g., SPC, EBR,
Information Systems).
3 Timing (if applicable).


Q u a lification
M a in Tests: SW Operational Qualification, cont:
3 Process Sequencing.
3 PLC Security.
3 User Interface Application / Operating System Security.
3 Verification/evaluation of SOPs.
3 Environmental Verification ( * ).


Q u a lification
l Q u a lification
Performance Qualification for the application.
Occurs under operational conditions but not as
part of the actual operational process.
Final verification of the im p lementation of the
URS.


Q u a lification
l Q u a lification, cont.
M a in Tests Performance Qualification.
3 Determination of the system accuracy in receiving,
recording, storing, and processing electronically
manufacturing information.
3 Determination of the system accuracy in arriving at the
appropriate disposition decision based upon the received
data.
3 Determination of the integration between all components.


Q u a lification
l Q u a lification, cont.
M a in Tests Performance Qualification, cont.
3 Platform security.
3 Audit trail reporting.
3 Systems backup.
3 System restoration.
3 Database recovery.
3 If database conversion, migration, or pre-loading with data
is to occur prior to PQ testing, the verification of these
activities and their associated data may be addressed in the
PQ.
3 Process Sequencing.
C o n trols during operation

O p e ration controls
C o n tro ls are required for the ongoing

operation of the system .
problem reporting
change control
user operating procedures
operating procedures such as back-up and recovery,
database administration
disaster recovery
preventive maintenance
environmental control
training
security
periodic reviews

Thank you for your attention!
FIN

Questions?
Orlando Lpez
(215) 273-7903
olopez@ m ccus.jn j.com

PLC C PDF

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

PLC C PDF

Uploaded by

Copyright:

Available Formats

IIRs Computer and Software Validation Processes

July 26-28, 2000 in Washington DC

( PLC based architecture)

Orlando Lopez, McNeil Consumer Healthcare 1

Orlando Lopez, McNeil Consumer Healthcare 2

This session outlines item s to consider

Orlando Lopez, McNeil Consumer Healthcare 3

l O . Lpez, A Practical G u ide to Regulatory

Orlando Lopez, McNeil Consumer Healthcare 5

W h a t is an autom a ted m a n u facturing

l In sim p le term s , it is the use of com p u ters to

Orlando Lopez, McNeil Consumer Healthcare 6

An exam p le of a sim p le autom a ted

Orlando Lopez, McNeil Consumer Healthcare 7

Finan- Recipe Quality * Document M a intenance

PLC PLC I/O PLC BAS

I/O I/O I/O I/O

Orlando Lopez, McNeil Consumer Healthcare 9

l PLC softw a re, e.g., Ladder Logic.

Orlando Lopez, McNeil Consumer Healthcare 10

P L C B a s ics -- Validation Issues

Orlando Lopez, McNeil Consumer Healthcare 11

Pharm a c e u tical Manufacturing

Orlando Lopez, McNeil Consumer Healthcare 12

3 Hardware, classified as equipment.

Orlando Lopez, McNeil Consumer Healthcare 13

G M P R e g u lations that apply to CS

Orlando Lopez, McNeil Consumer Healthcare 14

G L P R e g u lations that apply to CS

Orlando Lopez, McNeil Consumer Healthcare 15

G L P R e g u lations that apply to CS

Orlando Lopez, McNeil Consumer Healthcare 16

International Conference Harm o n ization

Orlando Lopez, McNeil Consumer Healthcare 17

O ther Key Regulations / Guidelines

Orlando Lopez, McNeil Consumer Healthcare 18

C o m p liance Policy Guidelines

I/O Checking (CPG 7132a.07).

Orlando Lopez, McNeil Consumer Healthcare 19

21 CFR 11 as a CSV model

Current Best Practice

Current Generation of Systems New Generation of Systems

Orlando Lopez, McNeil Consumer Healthcare 20

A u tom a ted M a n u facturing

Orlando Lopez, McNeil Consumer Healthcare 21

A u tom a ted M a n u facturing System s

A s y s tem a tic process to verify and test the

Orlando Lopez, McNeil Consumer Healthcare 22

Orlando Lopez, McNeil Consumer Healthcare 23

Critical Deliverables: W h y , What, How and

C h a n g e C o n trol H o w / W h e n it w ill b e m a intained

Orlando Lopez, McNeil Consumer Healthcare 24

Orlando Lopez, McNeil Consumer Healthcare 25

Orlando Lopez, McNeil Consumer Healthcare 26

C o n tro l System D esign

Piping and I/O L ist

Orlando Lopez, McNeil Consumer Healthcare 27

E lectrical and Instrum e n tation Design

Code and Standards. M o tors.

Orlando Lopez, McNeil Consumer Healthcare 28

Orlando Lopez, McNeil Consumer Healthcare 29

P L C s -- the equipm e n t / m a c h ine com e s

Orlando Lopez, McNeil Consumer Healthcare 30