As of May 2018, we are ISO 13485:2016 Certified We are proud to announce that Pangeanic has successfully passed external audits by British Quality...
2 min read
06/08/2018
The August issue of the Pharma Technology Focus magazine features Pangeanic and the fact that since May 2018 we have been certified ISO 13485 by EQA.
This magazine dedicated to the pharmaceutical industry brings readers the latest news and analysis in an exciting, interactive format with the latest insights and innovations, new discoveries, R&D and clinical trials, manufacturing technologies, and supply chain management. Pangeanic plays an important role in this chain, where lives depend on accurate translations.
Pangeanic is fully ISO 13485 accredited
The article includes information regarding Pangeanic's new ISO announcement after successfully passing the external audits by British Quality Certification body EQA to be able to add ISO 17100:2015 (replacing EN 15038) and ISO ISO 13485:2016 to our ISO 9001:2015 certification.Through our partnerships with some of the most important life sciences companies in the world, we have strengthened our commitment to our partners by demanding a stricter emphasis on control through our internal quality management systems (QMS), by obtaining the iso 13485 accreditation. Pangeanic’s QMS allows no room for errors in planning, processes, resources and finally translation which in turn ensures consistently high-quality standardsGarth Hedenskog –Sales and Marketing Director at Pangeanic Our industry is constantly evolving and standards and methods are always improving. Pangeanic will always be a company striving to be the best for our clients and when news broke of a new standard we should be in line with, we jumped at it. We brought in reputed EQA auditors to thoroughly investigate our processes to ensure we are completely in line with our top clients’ standards.
We translate as if lives depend on it!
Well, on a daily basis millions of lives do depend on accurate translations. Pangeanic, as a certified company under this standard, has documented procedures for both selecting specialized linguists in the healthcare sector and also the entire translation workflow process in order to ensure quality and excellence for all of our clients. Pangeanic was first certified in 2007 with EN 15038 (predecessor to the ISO 17100 standard). Since then, we have systematically controlled all of our processes, from human resources to staff training, translation quality control, documentation control and traceability for specific translation services. Pangeanic has proven diligence in these certification processes, together with extensive experience in translation project management. As a global company, our clients in Asia, Europe, the US, Canada, Latin America, Gulf countries, North Africa, India, Singapore … in fact more than 40 countries can certify our commitment, so next time you think languages, think Pangeanic.
Top Secret for Government Level Encryption and Security when Transmitting Sensitive Data
Recently, and as a result of Pangeanic’s involvement in the EU program “Connecting Europe Facilities”, we have implemented support to the AS4 standard for secure protocols when dealing with sensitive information. The key features of AS4 as messaging standard are:- Interoperable: AS4 is defined as an OASIS standard. It is built on top of existing standards, which have proven interoperability in the past: MIME, SOAP and WS-Security. This results in the high likelihood that different partners (Pangeanic and the customers) can communicate without the need to change their current infrastructure.
- Secure: AS4 assures message non-repudiation and data confidentiality.
- Reliable: AS4 guarantees once-and-only-once delivery, via the exchange of acknowledgements and additional requirements on the side of both the sender and the recipient.
- Payload agnostic: AS4 can exchange any kind of payloads (document formats) and it also supports multiple payloads being sent in one AS4 message.
Finally, the article offers a couple of tips: In keeping with the theme of privacy, traceability and accessibility, we also have a fantastic translation management portal which focuses on working around our clients’ schedules and is heavily focused on security. Extremely user-friendly, we created an environment where you can manage all aspects of your translation project from start to finish without a project manager having to get involved.
Translation management portal Video And as a parting gift… Top Tips when launching a translation campaign for a new product
Remember, Pharma Technology Focus is free to read on all devices.