At OdysseyVC we are constantly researching our market so that we can better serve the needs of our customers. This is a critical function for any company who wishes to not only succeed but to excel in their field. The uncertainty brought on by the sheer diversity of the global marketplace can create problems for the R&D, design, manufacture, distribution and marketing of products. This insights page aims to bring some of our learnings, achievements and goals as a company to our customers and indeed to a wider audience in the hope that we can pass some value back.
We recently attended a seminar in Brussels to examine the impact of the EU’s General Data Protection Regulation (GDPR) on the operation of R&D and science and on collaborative research in the EU and with its global partners. Our interest is in the cross-over between the GDPR and the regulations that govern our clients businesses such as the CFR’s, PIC/S and Eudralex to name a few. The GDPR entered into force on 24 May 2016 and will apply from 25 May 2018. The regulation is aimed at empowering the citizens as owners of personal data, as well as establishing legal certainty for business based on clear and uniform rules.
The GDPR will apply to all organizations in and outside the EU that deal with the personal data of EU individuals. Science-based and research organizations will need to take advantage of the two-year transition period up to 25 May 2018 to prepare for a significant increase in their data protection responsibilities and advance their privacy compliance programmes.
read more >Odyssey VC are delighted to announce that we plan to create 100 new jobs from our headquarters in Sallins, Kildare.
Odyssey VC offer Integrated GxP Cloud and Computerised System Lifecycle Management Services to Life Science companies that operate in highly regulated environments. Due to significant and consistent year-on-year growth since our establishment in 2015, we will be creating highly-skilled new roles which will be spread across the company’s technical, product development, service delivery, compliance and sales and marketing departments across multiple countries as part of our exciting and ambitious global expansion plans.
This announcement coincides with the official launch of Compliant Cloud, Odyssey VC’s new online platform. Compliant Cloud is an innovative new platform delivering market-leading compliant cloud solutions and features the world’s first self-care portal for the deployment of audit-ready compliant architecture. To find out more about Compliant Cloud, visit the website here.
The announcement took place yesterday (January 16th) in the Chamber in the Kildare County Council. The event featured speeches from Fianna Fáil councillor and Mayor of Kildare Suzanne Doyle, Head of the High Potential Start-Ups Unit at Enterprise Ireland Jennifer Melia, CEO of Odyssey VC and Compliant Cloud Oisín Curran, and Fine Gael chairman Martin Heydon. The event was well attended, receiving coverage from numerous media outlets. We couldn’t be more excited about this development and look forward to taking the next step in our journey.
read more >By Nicola Brady
The culture of an organisation directly correlates with the validity and accuracy of the data that it generates. In the on data integrity (Data Integrity and Compliance with Drug cGMP: Questions and Answers Guidance for Industry (2018)) the following is stated ‘it is the role of management with executive responsibility to create a quality culture where employees understand that data integrity is an organisational core value and employees are encouraged to identify and promptly report data integrity issues’. An organisation with a poor or immature Quality Culture can often have poor or immature quality practices, whereby issues are not appropriately documented, investigated and remediated. These organisations inevitably encounter challenges in adhering to and often have poor regulatory inspection records with repeat observations and violations. Conversely, organisations with a strong Quality Culture perform well with the regulators. These organisations are not error-free but their quality culture promotes a ‘do the right thing’ ethos when errors and issues arise.This transparency and openness gives the regulators confidence that the organisations data integrity is assured.
At Odyssey VC and CompliantCloud.com we endeavour to promote a culture of Quality across all organisations and functions at all level of the organisation to assure the integrity of all of our data and to ensure the provision of quality services and products to our customers.
read more >Quality standards are an essential flag to fly for any organisation. On that note we are both very proud and happy to notify our clients that we have received our ISO 9001:2015 certification. Why proud you might ask? Well the team here at OdysseyVC, spearheaded by the expertise and drive of Fionnán Friel, managed to design, install and make live an ISO compliant Quality Management System (QMS) in the unheard of time frame of 3 months!!
This is an unbelievable achievement and, though you might think this is a mistake, this is just a reflection of the quality work we are capable of producing under time pressure at OdysseyVC. We can assure you it is not a mistake and we are actively executing live projects, continuous improvement, supplier auditing and training in line with the standard. We have a long way to go to achieve everything we have planned for OdysseyVC and this is just one small step on this very long, exciting journey.
OdysseyVC IQNET ISO 9001:2015 Certificate
OdysseyVC NSAI ISO 9001:2015 Certificate
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