| | DECEMBER 202119CIOReviewfunctionality allows clients to store data without a long-term commercial contract, thus giving them the freedom to determine the longevity of the partnership. The combination of this functionality with effectiveness in data preservation fosters a culture of trust and assurance, leading to an enriching customer experience and long-term relationships with clients. Arkivum has also invested into developing quality management systems (QMS) and computer system validation (CSV) processes in accordance with GxP. "Our software and our services are underpinned by one of the most robust QMS and CSV systems in the industry," adds Sigley. Arkivum's collaboration with a US-based clinical-stage biotechnology company sheds light on its ability to store eTMFs in a manner compliant with Good Clinical Practice (GCP). As per the guidelines, TMF data was being retained for a prolonged period, but the client had found that this raised such challenges as potential future data corruption, lack of accessibility for stakeholders, uncertain readability of storage formats, and more. To address these issues, the client partnered with Arkivum and drew assistance in storing the eTMFs in accordance with GCP, FDA and ALCOA+ principles. Before storing the data, Arkivum's solution reviews the data quality and proactively resolves any issues within it. This ensures that no underlying issues could impact the readability and integrity of the stored eTMFs. Hence, with capabilities such as these, the client could achieve compliant status for years to come without any hassle.Building on such successful collaborations, the company is on the path to rapid success. Having recently completed a fundraising process a little while ago, it has all the necessary tools to heighten its presence in the data archiving and preservation sector and cement its position as a market leader. In a similar vein, Arkivum is looking to expand in the US and other regions. Moreover, with regulations changing continuously, it is always looking to enhance its technology and user interface capabilities for an improved experience. "Understanding the need for data preservation, we are working on several initiatives to bring our enhanced solution to sectors such as higher education, research, corporate and heritage records across the globe," concludes Chris Sigley. Clients can rest assured that any content stored on our solution can be easily accessed at any moment of time by stakeholders, auditors and inspectors for appropriate assessments
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