1. Corporate Overview
Cygnus is a Wonderware®
System Platform Certified System Integrator. We have a number of
certified Wonderware Application Developers on staff with many years of experience designing,
implementing, and commissioning Wonderware based SCADA systems. Highlights of our
Wonderware SCADA system experience include:
 Implementation of large systems up to 50,000 I/O;
 Delivery of high availability solutions, including multiple redundant application servers
and DA/OPC Servers;
 Design of secure network solutions to meet Cyber Security requirements, including
design and configuration of switches, routers, and firewalls;
 Implementation of complex multi-screen HMIs;
 Experience with several software engineering methodologies, including nuclear, military,
and pharmaceutical standards
 Delivery of systems in regulated industries, including GxP and nuclear safety software;
 Implementation of virtualized solutions, including thin client HMIs and HyperV and
VMware hosted application servers and historians;
 Design and delivery of reporting solutions, leveraging data in the SCADA historian and
other systems; and
 Integration with controls systems, plant information systems, Manufacturing Execution
Systems (MES), and ERP (Enterprise Resource Planning) systems.
Quality Management System
Cygnus maintains a Quality Management System (QMS) that is ISO 9001:2008 registered. This
management system includes policies, processes and procedures intended to demonstrate our
ability to consistently provide services that meet customer (both internal and external)
requirements and to enhance customer satisfaction now and in the future. Our company is
committed to ongoing effective application of our Quality Management System including
processes for continual improvement.
The Cygnus Quality Management System is based on recognized international quality
documents including:
 ISO 9000:2005, Quality Management Systems – Fundamentals and Vocabulary;
 ISO 9001:2008, Quality Management Systems – Requirements;
 ISO 9004:2009, Managing for the sustained success of an organization – A Quality
Management Approach;
 ISO/IEC 90003:2004, Software Engineering – Guidelines for the application of ISO
9001:2000 to computer software;
 GAMP 5, A Risk-Based Approach to Compliant GxP Systems
 CE-1003-STD Revision 0, Standard for Software Engineering of Category III
Software (Nuclear Safety Related Software)
The Cygnus QMS has been independently audited by QAS International. and has been
accepted by regulated customers for meeting their quality-related requirements.
The QMS incorporates a number of key quality management processes including Project
Planning, Control of Change, Senior Technical Review and Internal Auditing.

2. McNeil Consumer Healthcare Online SPC System
As part of the Zero Defect initiative, McNeil has implemented a Wonderware based data
collection and online Statistical Process Control System. Cygnus Consulting Inc. provided the
design and system integration services for the J&J’s McNeil Consumer Healthcare facility in
Guelph Ontario. The SPC charts may be used by operators for quality decision making and as
such the system is required to meet 21 CFR Part 11 Electronic Record software QA
requirement.
Cygnus provided the following specific services
 Participated in the development of the URS
 Developed the FS
 Developed the DS
 Configured the Wonderware application to meet the functional and design requirements
 Assisted McNeil in the development of the test protocols
 Participated in software validation activities
 Developed operator training material
 Conducted operator training