Systech International, a global technology leader in brand protection solutions, announces the expansion of its operations in China. The new entity, Systech Shanghai Consulting Company Limited, enables Systech to extend sales, implementation and customer support services to both its pharmaceutical company clientele, as well as consumer products, medical device and other companies looking to utilize Systech’s innovative anti-counterfeiting technology. For clients with Chinese manufacturing, packaging, and distribution, Systech’s expanded presence provides local support for its serialization, track and trace, and authentication solutions.
Systech International, a global technology leader in brand protection solutions, is proud to sponsor a live webcast titled “Unexpected Item in the Branding Area,” taking place June 6, 2017 at 11AM EDT | 4PM GMT | 5PM CET. The webcast will feature Mark Davison, CEO, Blue Sphere Health—an author, consultant, and leading anti-counterfeiting and product security technology expert, and Jim Sinisgalli, Systech UniSecure™ Director of Product Management, Brand Protection.
GAMP, also known as Good Automated Manufacturing Practice (GAMP) is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. Why follow these guidelines? First and foremost, because most markets in the world require it. Second, because it makes sense to ensure patient safety.
Systech International, a global technology solutions leader for the pharmaceutical industry, is proud to announce its upcoming serialisation webinar titled “The Clock is Ticking: Overcoming the Challenges of Implementing Serialisation in the EU” on 24 May 2017. This webinar is in response to the upcoming FMD deadlines for coding, serialisation, compliance reporting, and verification—as well as the need for flexible, reliable, hardware vendor-neutral solutions to meet these requirements. The new regulations are effective 9 February 2019, giving pharmaceutical companies, their CMO/CPO partners, and others who license pharmaceutical products less than two years to meet an extensive set of requirements. These directives apply to all EU member states, EEA members, and Switzerland.
Systech International, a global technology leader in brand protection solutions, is proud to feature its innovative serialization and traceability solutions at Interpack 2017 on 04-10 May 2017 in Düsseldorf, Germany. Systech will demonstrate its solutions in collaboration with three of its value-added partners: Etipack, Inno4Life, and Videojet.
Given the increasing number of counterfeit medicines and the fast-approaching EU Falsified Medicines Directive (FMD) deadlines, as well as serialization deadlines worldwide, the pharmaceutical industry is now entering a crucial phase. Stakeholders throughout the supply chain must comply with the new regulations to ensure maximum patient safety.
When implementing serialization, drug manufacturers and contract packagers need to be mindful of the complete costs. Serialization should be viewed as an enterprise solution, rather than a series of isolated local plant or packing line decisions. The initial costs include the direct costs of software, hardware, systems integrations and validation. Often underestimated, however, are the impact that serialization has on an existing IT infrastructure and the integration costs required to ensure the integrity and security of data as it flows through the enterprise. View Systech’s Top 5 Total Cost of Ownership (TCO) considerations to help companies quantify, understand, and control the full costs of serialization.
Systech International, a global technology leader in brand protection solutions, is proud to feature the company’s full array of technology solutions at LogiPharma, the largest global event for supply chain leaders from top pharmaceutical companies. Systech will feature its serialization, traceability, and authentication solutions at Booth #1 from April 25-27, 2017 at the Montreux Music and Convention Center in Switzerland.
Systech International, a global technology leader in brand protection solutions, today announced its Spring 2017 Update to UniSecure™. Systech UniSecure is the only proven, non-additive product authentication solution that creates a unique identifier from an existing barcode or QR code. This electronic ‘fingerprint’ cannot be copied or duplicated—no matter how clever the counterfeiter. Furthermore, the solution requires no changes to existing packaging, offers fast implementation, and allows real-time authentication via any smartphone.
Friday March 17, 2017 was the last day stakeholders and the public could submit comments on Brazil’s draft regulation on pharmaceutical serialization and tracing. All comments collected will now be considered by ANVISA, the government’s healthcare regulator, as they draw up their final draft for approval by April 29, 2017. Once approved, that regulation will be used as trial guidelines for the operation of a 3-lot government-run pilot by selected participants. The pilot will run for one year, after which, ANVISA will have eight months to refine the regulations based on observations and data collected during the pilot. ANVISA will then publish a final regulation near the end of 2018 which will define the requirements for industry to follow, beginning near the end of 2021.
Drug manufacturers who market drugs in Europe will need to begin applying unique identifiers and an anti-tampering device to their packaging by February 9, 2019. Most companies are already aware of these well-publicized requirements of the Falsified Medicines Directive (FMD) and the E.U. Delegated Regulation (EUDR). Systech offers packaging line management and serialization solutions that will allow you to easily meet these requirements.