ISPE and the Open-SCS Working Group of the OPC Foundation signed a memorandum of understanding at the 2017 Europe Annual Conference in Barcelona.
The OPC Foundation is a global not-for-profit organization that pursues interoperability in automation by creating and maintaining open specifications to standardize the communication of acquired process data, alarm and event records, historical data, and batch data to multivendor enterprise systems and between production devices.
The agreement formalizes a collaborative relationship to promote a technical standard for system integration for health care packaging, serialization regulation compliance reporting, and mass tracking of serialization numbers.
This GAMP®-based implementation will define:
The open packaging serialization global name space
The packaging serialization user requirement specification for business and operations processes
The packaging serialization system integration functional requirement specification (EPCIS framework), which will become a GS1 EPCIS standard application
The packaging serialization OPC-UA companion specification with OPCF compliance certification
Secondary goals include promotion of the Open-SCS serialization work by ISPE and promotion of the GAMP-based development and implementation by the foundation’s Open-SCS Working Group.
GROWTH IN ATTENDANCE AT THE ISPE EUROPE ANNUAL CONFERENCE 2017–2019
HEALTH APPS AROUND THE WORLD 1
200 new apps added per day
Over 318,000 available worldwide
ISPE launched its complimentary Pharma Best Practices Webinar Series in April. The debut was outstanding, drawing more than 850 registrants and over 500 real-time participants representing 62 countries and six regulatory agencies from around the world.
Delaware Valley Chapter Executive Vice President Eleanor Small, 34, is a woman with a passion for science and technology. Although still early in her career, she has already accomplished a lot, including being awarded the prestigious Delaware Valley Young Engineer of the Year award for 2019.