The EU General Data Protection Regulation (GDPR) represents a sea change in data protection, and nowhere more so than in Life Sciences. In a matter of months, individuals such as patients and clinical trial subjects will enjoy a raft of new rights concerning the personal data you hold about them.
If yours is one of the 45% of organizations without a structured process in place to comply with GDPR then download our white paper for clear guidance through the complexities of this far-reaching data protection regulation.
Arkivum TRUST is an end-to-end secure digital safeguarding and preservation archival solution built to address the unique challenges of the life sciences, pharmaceutical and health markets.
Arkivum TRUST is a modular solution that scales from an entry-level to an enterprise solution, from a central location to a fully-distributed topology, optimizing total cost of ownership (TCO) through cost-effective management of predictable IT costs.
It can be very difficult for an organization to assert that its digital records are authentic, reliable, and have the credibility to act as effective evidence of business actions over a long period. In many cases, legal admissibility of digital records managed by an organization’s records systems cannot be ensured. As a result, there is a growing need for a robust solution that guarantees these requirements for digital records. Arkivum TRUST delivers this level of assurance.
Archiving and safeguarding challenges
- Archiving is required for data integrity which is at risk throughout the entire longitudinal lifetime and retention period, particularly difficult when this could be decades and needs to be preserved for legibility, such as:
- Product quality for pharmaceuticals
- Diagnostic quality and integrity for health
- Trustworthiness of life science research
- Safeguarding raw data to prove it has not been manipulated, or processed, is a challenge. Raw data can include worksheets (quality records), memoranda, or notes from original observations, measurements or activities.
- Protection of data when it is personal identifiable information requires additional safeguarding consideration which is essential for GDPR.
- Sharing data whilst complying with data sovereignty, protection and privacy is increasingly challenging as the level of collaboration increases in life sciences, health and pharma. It puts pressure on the infrastructure, controls, and the simplicity required for multiple users to access the system.
- Often live data collection systems are designed for live data capture, as the data builds up these systems’ performance reduces and data management becomes more expensive. For example, EDC, EHR and LIMS systems are designed to collect patient data within the scope of the system. Business continuity and disaster recovery processes are required due to the variety of users.
Key Industry and Regulatory challenges
New MHRA GxP Data Integrity regulations scheduled for 2017 are drawn from the ALCOAC model:
- Increased inspection data integrity oversight on digital records and original data
- Dealing with the operational costs of digital data regulation management in a rapidly changing international regulatory landscape
- Approaching the increasing number of obsolete software repositories, obsolete data formats, and end-of-life infrastructure
- Increasing cost and productivity pressures in the pharmaceutical industry – typically 20% of operational costs relate to regulation management, and 5% of an individual’s time is spent finding records
Managing regulatory records and data effectively is about ensuring compliance, reducing risk and total cost of ownership. To meet these objectives, the most important capability is a single seamless and end-to-end solution with the ability to capture, safeguard and manage the data lifecycle, and provide access to and dispose of any record, from any system, in any state, with GxP data integrity.
If you manage different types of records in different systems, and data silo’s, you are likely to be increasing risk, reducing compliance, and increasing the cost of ownership.
Connect with Daniel Hickmore
Arkivum TRUST High Level Architecture
Arkivum TRUST is an enterprise SaaS platform designed to meet the challenges of long term, high volume records management.
Leveraging secure, protected services on a scalable, modular architecture, Arkivum TRUST caters to the needs of customizable workflow management on varying volumes of data.
- Comprehensive set of management and monitoring tools
- APIs, out-of-the-box, all of which can be flexibly deployed to meet industry and geographic requirements
- No vendor lock-in
Arkivum Visualization Module
Arkivum Preservation Module
Arkivum Integration Module
Arkivum Usability Module
Arkivum Compliance Module
Arkivum Safeguarding Module
Key customer benefits
- Reduce risk, meet compliance, automate data safeguarding and preservation of digital assets
- Reduce management overheads by managing digital regulated records with a simple user interface for staff and inspectors
- Reduce the risk of obsolescence with long-term retention and the cost of recovery for files through automated file format preservation
- Reduce IT costs by managing all file archiving irrespective of age, format, location, regulation, file type
- Integration with digitization partners enables streamlined digitization process and validation management
- Increase compliance and reduce risk with a comprehensive integration, enabling multi-system, application integration into one place
“In the healthcare sector, cost saving is an important factor in system specification, and the Arkivum solution functionality and ease of use has greatly helped us achieve our goals in this area.”Nick Housby
Case Study: Oxford Molecular Diagnostic Centre / Oxford NHS Hospitals NHS Trust
Case Study: Phlexglobal
Phlexglobal and Arkivum have partnered to implement a regulatory compliant electronic-archiving solution resulting in a reduction in eTMF maintenance costs.
Learn how the solution uses Arkivum and PhlexEview to manage millions of pages from a growing number of clinical trials.
Case Study: Bristol Genetics Laboratory, North Bristol NHS Trust
“As an increasing amount of data is being generated in this era of precision medicine, it is clear that there is a need for bioinformatics and IT solutions designed to ensure secure data governance. To that end, we are continually looking ahead in the interest of being in position to provide our customers with the most advanced tools, including new approaches to managing information that is compliant with regional regulatory agencies.”
Leader of Field Services and Support, Thermo Fisher Scientific