TraceLink Launches Early Access Program for Life Sciences Cloud
TraceLink launched the EU-hosted early access program to reduce the time, cost, and risk of achieving regulatory compliance for global requirements.
On Nov. 1, 2016, TraceLink announced the launch of an early access program for a European Union-hosted Life Sciences Cloud. The cloud will be available to TraceLink customers and trading partners in February 2017. With data residency in both the EU and United States, global customers can utilize TraceLink’s network-tenant platform approach to reduce the time, cost, and risk of achieving regulatory compliance for global requirements, including the EU Falsified Medicines Directive (FMD), and eliminate the need to verify and certify point-to-point connections to each government system.
As the industry prepares for the 2019 deadline for the EU FMD, the need for greater vigilance around drug-product security in the EU has become increasingly crucial in light of recent drug counterfeiting incidents. In Europe, counterfeit medicine accounts for an estimated industry loss of approximately €10 billion (approximately $11.04) in annual revenues and direct employment losses of approximately 38,000 jobs, according to a recent industry report. TraceLink’s Life Sciences Cloud is used by 444 customers and 242,000 partners on the global network. The cloud provides security for drug products that are manufactured, packaged, sold, and dispensed in the EU.
European data residency for the Life Sciences Cloud will be hosted by Amazon Web Services and deployed in Germany across multiple availability zones designed to automatically route serialized data feeds to the appropriate global region.
With offices in the United Kingdom, India, Singapore, and the US, 69% of TraceLink’s current pharmaceutical and contract manufacturing customers have compliance requirements for the EU (EU FMD), as well as other regions, including India, Brazil, China, South Korea, Turkey, Argentina, Russia, and Saudi Arabia.
Source: TraceLink
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
