Prisym Compliance
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The document discusses challenges in the life sciences industry related to drug and device labeling including rising costs, global compliance, and risk of medication errors. It then introduces PRISYM Life Science software as a labeling solution that provides full compliance, security, validation support, and integration capabilities to address these challenges. Key features of PRISYM Life Science include being purpose-built for GMP compliance, secure electronic records, customization options, and use across the product development lifecycle from clinical trials to distribution.
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Prisym Compliance
- 1. Drug and Device Labeling Control Chris Miller 310-265-3618
- 14. Counterfeit Viagra Counterfeit Viagra was found in the Summer of 2004 in two retail pharmacies in California. Bottles were for 100mg, 30-counts. Cost $270/bottle Cost < $1/bottle
- 15. Counterfeit Ponstan Ponstan is an anti-inflammatory product. This counterfeit was found in Columbia. The yellow powder consisted of boric acid, floor wax, yellow highway paint. Pressed into tablets and placed in foil packs with labeling. Source: Pharmaceutical Manufacturer Research Association
- 31. Goods Traditional Supply Chain
- 32. Goods Customs Traditional Supply Chain
- 33. Port of Departure Port of Arrival Supplier Distribution Center Distribution Center 1 st Mile Last Mile Goods Customs Active RFID reading + state sensing Active RFID reading + state sensing Passive RFID tagging + reading Active RFID reading + state sensing + de-associate Passive RFID reading Active RFID tagging + reading + association w/passive tags Enabled Supply Chain Visibility
- 34. Port of Departure Port of Arrival Supplier Distribution Center Distribution Center 1 st Mile Last Mile Goods Customs Active RFID reading + state sensing Active RFID reading + state sensing Passive RFID tagging + reading Active RFID reading + state sensing + de-associate Passive RFID reading Active RFID tagging + reading + association w/passive tags Enabled Supply Chain Visibility
- 35. Port of Departure Port of Arrival Supplier Distribution Center Distribution Center 1 st Mile Last Mile Goods Customs Active RFID reading + state sensing Active RFID reading + state sensing Passive RFID tagging + reading Active RFID reading + state sensing + de-associate Passive RFID reading Active RFID tagging + reading + association w/passive tags Enabled Supply Chain Visibility
- 36. Enabled Supply Chain Visibility Active RFID reading + state sensing Active RFID reading + state sensing Passive RFID tagging + reading Active RFID reading + state sensing + de-associate Passive RFID reading Active RFID tagging + reading + association w/passive tags Port of Departure Port of Arrival Supplier Distribution Center Distribution Center 1 st Mile Last Mile Goods Customs
- 37. Port of Departure Port of Arrival Supplier Distribution Center Distribution Center 1 st Mile Last Mile Goods Customs Active RFID reading + state sensing Active RFID reading + state sensing Passive RFID tagging + reading Active RFID reading + state sensing + de-associate Passive RFID reading Active RFID tagging + reading + association w/passive tags Enabled Supply Chain Visibility
- 45. Price vs. Features PRICE FEATURES Loftware Seagull Teklynx Teklynx NiceLabel Standard Series NiceLabel SE NiceLabel Enterprise Series Prisym Medica
- 46. Short List of Customers
Editor's Notes
- Counterfeit legal drugs include falsely-labeled drugs that were previously expired, drugs where the active ingredient is fraudulently diluted, adulterated, substituted, completely misrepresented, or sold with a false brand name. According to a report released by the (OECD), 75 per cent of fake drugs supplied world over have some origins in India, followed by 7 per cent from Egypt and 6 per cent from China. XML description of the life history of a product across an arbitrarily complex supply chain - Lot - Potency - Expiration - National Drug Code and Electronic Product Code - Manufacturer - Distributor, Wholesaler or Pharmacy - Unique identifier of the salable unit
- Counterfeit legal drugs include falsely-labeled drugs that were previously expired, drugs where the active ingredient is fraudulently diluted, adulterated, substituted, completely misrepresented, or sold with a false brand name. According to a report released by the (OECD), 75 per cent of fake drugs supplied world over have some origins in India, followed by 7 per cent from Egypt and 6 per cent from China. XML description of the life history of a product across an arbitrarily complex supply chain - Lot - Potency - Expiration - National Drug Code and Electronic Product Code - Manufacturer - Distributor, Wholesaler or Pharmacy - Unique identifier of the salable unit
- The hologram labels Prisym can produce ensure that the product not only is authentic and secure from counterfeiting, but is also branded with your company logo and ultimately looks good on the finished item.
- Compliance requirements Secure event log All label revisions and printing actions are fully commented and automatically recorded in the audit log.
- Compliance requirements Secure event log All label revisions and printing actions are fully commented and automatically recorded in the audit log.
- Number of clinical trial per NDA doubled over the last 20 years Number of needed patients tripled Clinical trials have trended steadily higher in both cost and complexity Clinical Supplies have to handle more and more throughput