Database for sources of GDPR and regulatory information
Integrated GxP services
Odyssey Validation Consultants (OVC) is an Irish company based in Co. Kildare. Its primary business is to support companies operating in highly regulated sectors in their implementation of computerised systems. With consultancy and cloud services, OVC operates globally with international clients including in North America and Europe.
The compliance requirements applicable to the computerised systems validation process in these sectors are significant. Failure to meet the requirements can result in very high penalties. The company must stay on top of a variety of key regulatory indicators including regulation changes, standards evolution, inter-jurisdictional cooperation, key areas of focus, infractions and incidents of non-compliance. The availability of relevant information varies from jurisdiction to jurisdiction. With an emphasis on data integrity, this project seeks to identify a comprehensive list of relevant actors and sources of information across major markets and to identify frameworks for maintaining a dynamic topic monitoring tool.
“We engaged with TSSG to deliver a critical piece of industry research that facilitates Odyssey’s market positioning into the future. We found the team to be excellent in understanding the business problem statement and in then delivering the desired end result. I would not hesitate in recommending the TSSG team.”Oisin Curran
The OVC & TSSG partnership
TSSG worked with OVC to develop a bank of information sources across main markets including regulatory, enforcement, thought leaders and industry think tanks. The information sources were analysed and assessed for relevance and recency. High-level solutions to maintaining dynamic, contemporary monitoring were discussed.
A heat map was developed which compared GDPR regulation with eCFR (computerised system regulations). This heat map assessed the different regulatory topics for commonality and conflict. A workshop was held with the client to discuss findings and implications.
Odyssey Validation Consultants was happy with the scale of work and the information collated and analysed. The workshop was constructive and based on key findings the client had secured internal resource to maintain and evolve the resources compiled. In addition, and based on workshop discussions, the client was keen to build its GDPR awareness and compliance into its overall key value proposition.