Arkivum is delighted to announce that we have been awarded recertification in both ISO 9001:2015, for our quality management system, and ISO 27001:2017 for our information security system.
The ISO 9001:2015 standard is based on a number of quality management principles which encompass a strong customer focus, motivation of senior management, processes adopted by the organisation and its commitment to the continual improvement of those processes. Organisations which adhere to the standard, ensure that customers receive consistent, good-quality services.
In a similar vein, ISO 27001:2017 is widely accepted as the leading standard for providing requirements for an information security management system, or ISMS. Complying with these requirements enables organisations of any size to manage the security of sensitive assets including financial information, clinical trial data or customer details.
Arkivum CEO, Chris Sigley, said of the announcement, “We are delighted to achieve recertification in both international standards. The award of these certifications demonstrates our commitment to the quality of our solution, the services we provide to our customers and security of both our and our customers data”.
He added, “This achievement further strengthens our commitment to support organisations and sectors who manage and store large amounts of sensitive information. This includes our customers within pharma and life sciences, who are heavily regulated and required to adhere to strict GxP standards and guidelines. We strive to provide our customers with the confidence and peace of mind that their data is in safe hands.”
You can access both certificates here;
Arkivum is recognised internationally for its expertise in the archiving and digital preservation of valuable data and digitised assets in large volumes and multiple formats. The long-term security, integrity and accessibility of data is crucial for all Arkivum’s clients and partners, who share a commitment to good practice in its stewardship and governance.
Arkivum’s specialist software and services are chosen by major institutions and commercial organisations from a diversity of sectors, including life sciences and pharmaceuticals, corporate, nuclear research (CERN), and organisations in higher education, culture and heritage. All Arkivum’s clients benefit from an insurance-backed 100% data integrity guarantee. Among them are CERN, Princeton University, London School of Economics, ThermoFisher Scientific, Idorsia and Oncologica. Headquartered in the UK, with US offices in Boston and New York City, Arkivum advocates and implements best practice in data management, including the FAIR principles: Findable, Accessible, Interoperable, Reusable. In particular, Arkivum helps organisations to build and operate Trusted Digital Repositories for their content.
Arkivum Trust is Arkivum’s dedicated digital archiving service for life sciences and pharmaceuticals. Its TMF (trial master file) archiving function enables sponsors of clinical trials and clinical research organisations (CROs) to maximise insight and discovery along with GxP and compliance, and so derive optimum long-term value, both scientific and economic, from their data and intellectual property.
Vendor-neutral and complementary to existing eTMF systems, Arkivum Trust provides a model for the stewardship of data, minimising risk and ensuring the end-to-end integrity, security and viability of clinical trial data, whatever its source and digital format.
By keeping large volumes of trial data alive in the archive, constantly accessible and inspection-ready, Arkivum plays a crucial role in maintaining quality control and compliance. By ensuring ready access to important reference materials, it unlocks the economic value of data beyond audit and inspections, facilitating scientific discovery, pharmacovigilance, new formulations and marketing approvals. In addition, it expedites corporate processes such as licensing, the establishment of partnerships, and due diligence for mergers and acquisitions.