Solutions for

ELECTRONIC DATA SECURITY

STERIS’ Electronic Data Security Options allow users to configure a comprehensive,

yet cost effective system to manage vital electronic data and comply with FDA 21
CFR Part 11 and European Annex 11 requirements.

Managing electronic data, complying with evolving regulatory STERIS’ complete Electronic Data Security suite:
requirements and reducing paper records can be a daunting task • Audit Trail
for pharmaceutical manufacturers. STERIS Corporation makes it • Password Security
easier with our suite of Electronic Data Security solutions, now • E-Signatures
standard options on most of our equipment. With STERIS, users • Data Archiving
can easily manage critical electronic data related to production • Batch Data Reporting
batches, equipment status and user actions. Whether you need to
pass electronic data to a centralized SCADA system or want to
build a stand-alone Electronic Data management solution,
STERIS has plan a for you.
STERIS Electronic Data Security solutions have been developed,
tested, and documented in accordance with GAMP 5 guidelines
and provide the capability for complying with FDA (21 CFR Part 11)
and European (Annex 11) regulations.
 Option 2
Option 1 STERIS Electronic Data Security with Data Archiving
STERIS Electronic Data Security - Siemens® and Enhanced Batch Reporting - Siemens®

HMI MP Panel PC Panel with Batch Report

PLC PLC

USB Port USB Port

Memory Card Hard Drive

• Batch Cycle Data • Batch Cycle Data
• Audit Trail • Audit Trail
• Local Storage • Local Storage

Sent to
Optional Printer

Ethernet to Customer Data System Ethernet to Customer Data System

• Batch Cycle Data • Batch Cycle Data
• Audit trail • Audit trail
• Access to PLC registers • Access to PLC registers

Upgraded Siemens® control package provides 21 CFR Part 11 and EU Annex 11
capability. Configured for users who have their own centralized data archiving
and reporting capability.
The system includes:
Siemens PLC S7 315-2PN/DP with MP277 (8”) Color
Touch Panel.
WinCC Flex® software with audit trail capability
• Audit trail includes user identification, time and date for initiation of
cycle, cycle abort, cycle parameter changes, alarm acknowledge-
ments, unsuccessful login/access attempts, etc. Audit trail is
viewable from the HMI.
Local memory card
• Local memory card for temporary data storage of audit trail and
batch cycle data.
Ethernet port
• Batch data and Audit trail can be exported to a Customer
supplied control system in a transportable format. Audit trail is
transferred in CSV format. Data registers can also be read from
the PLC via Ethernet.
Password Protection
• Password protection features including unique access levels,
aging, alpha numeric requirements, automatic log-out, etc.
E-signature
• E-signature for final batch verification/acceptance is available.
Upgraded Siemens® control package provides 21 CFR Part 11 and EU Annex 11
capability with data archiving and enhanced batch reporting.
The system includes: Ethernet port
• Audit trail can be exported to a Customer supplied control system
Siemens PLC S7 315-2PN/DP with SIMATIC Panel PC
in CSV format. Batch data can be exported in PDF format. Data
Touch Panel.
registers can also be read from the PLC via Ethernet.
WinCC Flex® software with audit trail capability
Password Protection
• Audit trail includes user identification, time and date for initiation of
• Password protection features including unique access levels,
cycle, cycle abort, cycle parameter changes, alarm acknowledge-
aging, alpha numeric requirements, automatic log-out, etc.
ments, unsuccessful login/access attempts, etc. Audit trail and
data is viewable from the PC. E-signature
• E-signature for final batch verification/acceptance is available.
Local Data Storage
• Local hard drive for storage of audit trail and batch
cycle data.
Batch Reporting
• Predefined Batch Report in PDF format. Batch report may be
exported or printed using optional printer.
 The STERIS Difference
STERIS’s Life Sciences division provides solutions to help prevent contamination at virtually every critical point in your
manufacturing process. Our systems are specially designed to answer the contamination challenges associated with regulated

The STERIS Difference

pharmaceutical environments, including research laboratories, aseptic processing, and bulk biopharmaceutical manufacturing.

Our expert
STERIS’s resources
Life Sciences offer
division integrated
provides solutions
solutions toprevent
to help help you achieve faster process
compliance validation,
issues, product safetymore
andefficient operations,
new technologies and and
greater cost
contamination control.every
at virtually We also provide
critical point inonsite training, educational
your manufacturing seminars,
protocols. Ourand technical
support support
is available to keep
when your employees
and where you need itcurrent
process.
with Our systemscompliance
regulatory are speciallyissues,
designed to answer
product theand
safety contami- through ourand
new technologies worldwide manufacturing
protocols. Our support presence and broad
is available when and where
nation
youchallenges associated
need it through ourwith regulated
worldwide pharmaceutical
manufacturing presence anddistribution channels. channels.
broad distribution
environments, including research laboratories, aseptic processing, STERIS Corporation is a leading provider of infection prevention,
STERIS
and bulk Corporation is manufacturing.
biopharmaceutical a leading provider of infection prevention, contamination prevention, microbial reduction, and surgical
contamination prevention, microbial reduction, and surgical support
support systems, products, services, and technologies
Our expert resources offer integrated solutions to help you achieve to healthcare,
systems,lifeproducts,
sciences,services,
research,andfood, and industrial
technologies customers
to healthcare, life
fasterthroughout the world.
process validation, more efficient operations, and greater cost sciences, research, food, and industrial customers throughout
control. We also provide onsite training, educational seminars, and the world.
technical support to keep your employees current with regulatory

Septihol® Sterile
Alcohol Solution
VHP® 1000ED
Biodecontamination
VHP® M100 System
Biodecontamination System

FINN-AQUA® GMP VHP® ARD

Steam Sterilizer Biodecontamination
Spor-Klenz® System
Ready-to-Use Liquid
Cold Steriliant

Verify® Sterilization
Process Monitoring VHP
Generator

Aseptic Care Freeze

Verify® • mixing Dryer
Self-Contained Hot Air • filling Products
Biological Indicators Sterilizer • closing Terminal
Glass • inspection Sterilizer
Bottles Washing • other
Equipment Steam VHP® MD Series
Sterilizer Low Temperature
Process
Components Sterilizer
& Material WFI
Pure Steam
Generator WaterStill
Water
Pretreatment
City Water

Purified Water
For Non-Sterile Use

CIP 100® and CIP 200®

FINN-AQUA® Multiple-
Process and Research
Effect Water Still
Cleaners
Reliance® 580
Reliance® 680Grade
Pharmaceutical FINN-AQUA®
Pharmaceutical
Washer Pure Steam
Grade Washer Generators

STERIS has a comprehensive offering of detergents, disinfectants, skin care products and sterility assurance products that support your needs. We also
have world class technical support to design the most effective cleaning program for your facility. Contact your local sales representative or refer to our
website at www.sterislifesciences.com

STERIS Corporation
STERIS Corporation STERIS OffIcES WORldWIdE Italy 39 022 130341
5960 Heisley Road Belgium 32 2 523 2488 Japan 81 78 321 2271
5960 Heisley Road
Mentor, OH 44060-1834 USA n Brazil 5511 5053 9823 Latin America 800 884 9550
Mentor, OH 44060-1834 USA Canada 800 661 3937 Nordic 358 9 25851
440-354-2600 800-444-9009
n

www.sterislifesciences.com China 86 21 6137 1166 Singapore 65 68 41 7677

www.steris.com France 33 2 38 70 83 50 Spain 34 916 585 920
#M00000
Germany 49 2203 890 6969 Switzerland 41 32 376 0200
©2011 STERIS Corporation Greece 30 210 6800848 United Kingdom 44 1256 840400
Document # M3213EN 2008-09, Rev. B ©2011 STERIS Corporation.
All rights reserved. Printed in USA.