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Elisavet Kyriakou  

Charles River Laboratories​​​​​​​

Elisavet Kyriakou is with Charles River Laboratories group where she works as a quality assurance auditor, focusing on the general animal toxicology studies. She is also involved in improvement of the use of new technologies and processes within the quality assurance department, such as Provantis and Dispense.

Before joining Charles River Laboratories, she worked as an early stage researcher at Noldus IT and Radboud University where she characterised and validated an animal model for a fatal neurodegenerative disease called spinocerebellar ataxia type 17.

Elisavet has a BSc in Biology, an MSc by Research in Neuroscience and is a PhD candidate in behavioral neuroscience from the Radboud University, The Netherlands.

 


Abstract

e-Archiving in the cloud: strengths and limitations. Are we in control?

Since the implementation of the OECD GLP principles in 1981, several documents on archiving have been issued. The transition from paper to electronic data, has made e-archiving important. In a world where global companies thrive, the use of global computerised systems and global archive locations play a key role. While ‘global’ offers great advantages with apparently no borders and physical limitations, other challenges appear. Regardless of whether it is a company or an external cloud, a server always has a physical location where the data is held and the impact of any ‘local’ laws applicable for the geographic location must be evaluated. Additionally, national requirements and procedures regarding archiving e-data can differ significantly, as monitoring authorities may have different interpretations of the guidelines. Another challenge is to ensure the integrity, readability and availability of the e-data during its life cycle and proper e-data transfer to stakeholders be it client or regulatory agencies. The increased use of a variety of computerised systems creating e-data leading in turn to an increase of e-data generation, poses a management and e-archiving challenge. E-archiving possible risks e.g. software version upgrades, or other changes on the application features that may influence the original data during its lifecycle should be considered. Cloud computing can be seen as outsourcing of IT infrastructure however the responsibility and accountability for GLP compliance remains with the regulated organisation. When using ‘cloud’ services, a formal written agreement describing the roles and responsibilities of each party and data ownership should be considered. Talking about cloud life cycle, means negotiation of the measurable levels of service and data backup and adopting a proactive and on-going auditing style to ensure compliance. Data migration from the cloud to another provider, application or archive should be clear in order to ensure continuity. In conclusion, the challenges of e-data archiving in the cloud should not be underestimated as these new challenges require a ‘future-oriented’ standpoint in order to keep track of all updates and innovations.

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