Pharma & Life Sciences – Long-Term Protection for Research Data and Critical Information
Data Integrity for Pharma and Life Sciences
From research data and laboratory results to production and quality records: pharmaceutical and life sciences companies, as well as research institutions and universities, rely on secure long-term storage and archiving of their information. To ensure this over years or even decades, companies must overcome a number of industry-specific challenges.
Regulatory Requirements
Pharmaceutical companies and research institutions must comply with extensive regulatory requirements such as GxP, FDA 21 CFR Part 11, EU GMP Annex 11, and other compliance demands. Archiving and storage solutions must ensure that data remains complete, unaltered, traceable, and available at all times over long periods.
Data Integrity & Auditability
Research, laboratory, and study data must remain authentic, traceable, and tamper-proof throughout their entire lifecycle. Ensuring long-term data integrity and audit trails is a central prerequisite for audits, inspections, and approval processes.
Protection Against Ransomware
Research data, study results, and intellectual property are among the most valuable corporate assets. Pharmaceutical companies and research institutions must effectively protect their data from ransomware, manipulation, data loss, and unauthorized access to safeguard research projects, development processes, and business continuity.
Growing Data Volumes
Modern research methods, laboratory automation, digital studies, and much more generate continuously growing data volumes. Companies and research institutions need scalable storage and archiving strategies to retain large data sets long-term and keep costs and operational effort under control. At the same time, it is important to automatically capture data from laboratory and analysis systems, archive it in an audit-proof manner, and sustainably relieve source systems.
Protect Research Data, Study Results, and Audit Trails Long-Term
Research, laboratory, and study data form the basis for innovation, quality, and regulatory compliance. Our patented storage and archiving solutions ensure that data remains complete, unaltered, and traceable at all times throughout its entire retention period. They protect sensitive information from manipulation, loss, deletion, and damage, securing its long-term integrity and availability.
The compliance functionalities of our solutions have been audited and certified by KPMG and Cohasset Associates. We support companies in Pharma and Life Sciences in implementing regulatory requirements such as GxP, FDA 21 CFR Part 11, EU GMP Annex 11, or AMWHV. Together, we examine how our solutions can best meet the specific requirements of your industry and organization. This creates the foundation for auditable processes, reproducible research results, and secure long-term data retention.
Compliance
Assessment
Long-Term Data Integrity and Availability with iTernity
iCAS Classic
iCAS Classic is flexible middleware for retention management & WORM data archiving. The software solution can be optimally integrated into existing IT infrastructures. While you focus on your core business, iCAS Classic reliably protects the integrity and availability of your data in the background.
iCAS FS
iCAS FS is a scale-out storage platform for diverse use cases related to long-term data storage. The software-defined platform is infinitely scalable and impresses with low total costs, easy handling, and high flexibility. Whether as secure backup storage, audit-proof archive, secondary storage, or cost-efficient object storage – iCAS FS meets your requirements for the long term.
iCAS Capture
With iCAS Capture, you extend your archiving strategy to include the direct capture of data from various sources.
The add-on automatically reads relevant information and seamlessly integrates it into the shares of iCAS FS or iCAS Classic. The data is then available in an audit-proof manner and can be securely removed from productive systems, significantly reducing operational effort, storage requirements, and complexity.
Special Delete Manager
Why Pharmaceutical Companies and Research Institutions Rely on iTernity
Whitepaper: Protecting Business-Critical Data in a Future-Proof and Software-Defined Manner
Learn in this Whitepaper how a software-defined approach can help you protect business-critical data in a future-proof, flexible, and cost-effective manner.
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