Open-SCS: WIPOTEC-OCS stands for open interfaces and standardization in Serialization & Aggregation
WIPOTEC-OCS along with global pharmaceutical companies and system suppliers support the Open-SCS Working Group (SCS = Serialization Communication Standard).
As a steering committee member of the Open-SCS Working Group, WIPOTEC-OCS advocates for flexible integration with existing production infrastructures and, above all, for an open and standardized connection philosophy to higher-level systems..
The main aim of Open-SCS is the successful combatting of the illegal trade in counterfeit drugs:
- The FDA (responsible US agency) reports the worldwide damage caused by counterfeit drugs at 35 billion dollars annually.
- The annual growth of the counterfeiting business is estimated to be approximately 20 percent.
- According to expert estimates, up to one million people worldwide will die each year as a result of taking counterfeit drugs.
- In the emergent and developing nations, the UN WHO estimates that about 30 percent of all drugs are counterfeit.
A number of states and their control organizations like the "US Food and Drug Administration" (FDA) or the "European Medicines Verification Organization" (EMVO) are committed to the same goals in terms of the global pharmaceutical companies and every individual patient. The "Drug Supply Chain Security Act" (DSCSA) for the USA and the "Delegated Acts" to supplement the European Directive 2001/83/EC to combat the falsification of drugs must be implemented within a certain time window and be of a global character. As the specified deadlines are approaching their end, manufacturers tend to implement short term solutions without any thought given to sustainability.
Open-SCS confronts this faulty thinking and calls for open connectivity standards to achieve, in this way, the standardization of the data exchange between production level and management level of a drug manufacturing company regarding serialization and aggregation. An open, independent, and standardized connection philosophy to higher-level systems reduces the risk of supply shortages and dependencies on a single technology provider.
The aims and advantages of Open-SCS WG at a glance:
- Eliminate artificial dependencies on suppliers and the need for proprietary solutions!
- Minimize the risk of supply shortages!
- Faster implementation via standard interfaces to support compliance with global implementation deadlines!
- Smooth validation processes because of consistent and standardized functions!
- Better competitive conditions and price advantages because no dependencies on one manufacturer!