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.
Odyssey VC will be attending two seminars hosted by ISPE in Rochestown Hotel, Cork, on the 14th of November. There will be two seminars; Women in Pharma, taking place in the afternoon, and Single Use Process in the evening from 7:00pm-9:30pm. Both seminars will contain presentations from industry experts followed by panel discussions. To set up a meeting with Odyssey VC surrounding this event, please visit our Contact Us page at the link below.
read more >
Patrick Murray, the Compliant Cloud Technical SME for Pharma VIEW (Validated Integrated Enterprise Workflows) is speaking in a webinar on the 24th of October that will help you to understand the benefits of going paperless, using some common use cases as inspiration. Save the date and don’t miss the opportunity to know more about validated workflows, the new paperless.
Find out more and register here: https://compliantcloud.com/webinar/
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
read more >
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 >
Implementing enterprise level computerised systems that support regulated activities is not a simple process. Forget about the regulatory requirements for a minute and just focus on the business impact. It is extraordinary to see the complexity that companies have introduced into their own business processes in their global operations. One acronym means a different thing depending on the person you are speaking to and their geographical location. And this is just an acronym! When analysing the business processes of global organisations we have only ever seen discontinuity, nuances, different organisation structures and so on. It makes the design of ‘standard’ business flows extremely difficult.
Why is this important when the topic of Cloud, or in this case, Regulated Cloud comes up? Well it is important because it points to a very important precursor to any cloud strategy and that is alignment of business processes, where possible, and alignment of organisational structure.
read more >
