Achieve Information Interoperability
Working together as one, without special effort. That is the promise of information interoperability — the ability of different information technology systems and software applications to communicate, exchange information and use the information in a uniform and efficient manner across multiple organizations and information technology systems.
For healthcare, interoperability means the ability of information systems to work together within and across organizational boundaries in order to advance the safety, security, health status of, and the effective delivery of healthcare for individuals and communities.
DSCSA item-level serialization provides a key enabler for Information Interoperability — the ability of manufacturing, packaging, distribution, health care, dispensing and patients to share information in an interoperable manner. Effective interoperability of serialized information provides visibility into item-level activity. This enables the manufacturer, distributor, pharmacist, and/or regulator to evaluate the integrity of a package and extract a detailed understanding of authenticity, chain of custody, channel integrity, and Current Good Manufacturing Practice (CGMP).
Gain Supply Network Visibility
Most supply chains are networks of separate, distinct suppliers. The virtual model of separate businesses aligning efforts to accomplish a common cause lowers cost barriers and accelerates products to market.
The virtual model has disadvantages too. Each supplier has a unique information infrastructure. That often makes receiving and sharing information from other similarly unique providers a challenge.
What is missing? Supply Network Visibility – the ability to track the state and status of key elements of supply chain efficiency and effectiveness.
With visibility comes clarity; and a clear view of inventory and supply network activity; this ensures safe, agile, efficient, and compliant supply chains.
Gaining actionable insight requires accurate, value-added, and timely information. The Internet Of Things and efforts to trace the what, why, when and who will provide the needed knowledge to achieve more.
Can different systems seamlessly interoperate? Common data exchange schema and standards are essential. For many industries traceability in the supply network requires adherence to GS1 standards and EPCIS compliance.
Attaining traceability is a significant challenge for any organization.
Increasingly pharmaceutical traceability is being mandated worldwide. Efforts to achieve serialized interoperability in a validated, CGMP-compliant environment, and with numerous, virtual partners throughout the entire supply network, is a daunting mission.
Since 2006, BrandSure has successfully managed more than 35 serialization-focused engagements, many of them facilitating federal and state regulatory compliance. BrandSure is a member and alliance partner of GS1 US and contributed to the authoring of DSCSA and Traceability Implementation Guidelines.
BrandSure will quickly assess gaps in process and technology to deliver actionable compliance strategies and project plans.
- EPCIS compliance assessment
- Supply Integrity strategy
- Actionable roadmap