Cloud service and management specialist Egenera has partnered with Odyssey Validation Consultants (OVC) to offer a new compliant GxP Cloud Service, on the service provider’s Xterity Cloud platform, to serve highly regulated industries.
The OVC GxP Cloud delivers fully compliant cloud services to regulated companies in the life sciences sector and in the connected health/IoT space, ensuring data integrity in an audit ready environment, say the partners. OVC said it has worked closely with international regulatory authorities to develop its GxP cloud offering to ensure it meets and exceeds the requirements in this space.
The OVC GxP Cloud enables organisations to easily migrate validated GxP computerised systems to the OVC GxP Cloud to reduce costs and improve flexibility. Xterity runs out of Tier 3 and Tier 3+ data centres in Ashburn, VA and San Jose, CA, in the US, as well as Dublin, London and Tokyo.
“I am always looking into new mechanisms to enhance our ability to utilise new technologies in the deployment of compliant GxP Systems,” said Emmett Nolan, IT manager, Aspen Pharma Trading Limited. “My IT strategy is focused on the move to cloud platforms capable of supporting applications subject to regulatory oversight. As such, I have found that the GxP Cloud offering and supporting Lifecycle Management Services offered by OVC in conjunction with the technical performance of Egenera is an excellent fit for us.”
Public cloud shortcomings
Oisín Curran, CEO, Odyssey Validation Consultants, explained that for the most part, public cloud infrastructure, such as infrastructure as a service (IaaS) is not suitable for highly regulated companies operating in the life sciences sector to host applications involved in any GxP activity (where ‘x’ is Manufacturing, Clinical, Distribution etc.) – referring to the Good ‘x’ Practices.
This is a major reason, said Curran, for the slow move of Life Science companies to the cloud, as there are few to no true GxP Cloud options in the IaaS marketplace capable of supporting GxP applications. These regulated companies require a GxP-compliant IaaS and this is what OdysseyVC now provide – GxP Compliant Cloud.
The requirements of these highly regulated companies, Curran said, are defined by the regulatory bodies who audit them and subsequently licence them to market controlled products in their jurisdiction(s). It’s important to note that there is no certification to be achieved that demonstrates compliance for these bodies. This is a way of doing business that comes from demonstrated evidence of consistent practices and this is what OdysseyVC are providing. An ‘audit ready’ GxP Cloud IaaS offering
Adoption lag
“Until now,” said Pete Manca, president and CEO, Egenera, “there’s been a lag in cloud adoption by regulated companies due to the availability of true GxP compliant cloud offerings. With the announcement of the OVC GxP Cloud, organisations can move more quickly than ever to the cloud and rest assured that they’ll meet stringent requirements.
“Organisations who will benefit from the OVC GxP Cloud include life sciences, companies who are required to store and maintain medical records and companies working in connected health,” said Manca.
Unique position
Curran said that OVC is uniquely positioned to provide for the GxP requirements of clients in the highly regulated space.
“Having trained auditors of regulated bodies, we are in the unique position of understanding their requirements, and that of our clients in the GxP Compliant Cloud space,” said Curran. “In addition to this, we are a company coming from the client side and delivering a technology solution to meet the business need. These stringent requirements are at the core of our internal business processes so it is not difficult for us to meet the requirements but that does not mean it is not complicated.”
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