Quality, Compliance, and Integrity.
Built-In.
State-of-the-art drug development software streamlines and accelerates workflows. At the same time, it has to ensure compliance at every step. From secure data handling to traceable data and processes, technology must uphold the highest standards of integrity and reliability.
This is where Genedata comes in.
Our Customers
We needed a central platform to capture and process data across our global R&D teams, while ensuring full data integrity and traceability, and Genedata was the only solution that ticked all the boxes right from the start.
Industry Standards. Applied.
For the deployment of our solutions in regulated environments, Genedata software is designed and developed in accordance with internationally recognized standards and industry best practices. Guidelines such as GAMP 5 are used to ensure fitness for intended use and the compliant support of GxP business processes under:
- GMP (e.g., 21 CFR Part 210, 211, 21 CFR part 11, Eudralex Vol 4 Annex 11)
- GCP (e.g., ICH E6, EudraLex Vol.10)
- GLP (e.g., 21 CFR Part 58)
View our Genedata Quality Policy for more details.
SOC2 Compliant. ISO 9001 Aligned.
Designed to provide data integrity, security, and traceability, our platform includes scientific, domain-specific quality factors that are developed in-house by scientists, bioinformaticians, statisticians, software engineers, and quality professionals. Software development and service processes at Genedata are aligned with ISO 9001 requirements. We manage and protect information within a full information security framework. To ensure Genedata’s security controls are compliant, our information systems and processes are externally audited by an independent CPA firm, and we maintain a current SOC 2 Type 2 report.
Compliance. Out-of-the-Box.
- System access limited to authorized users only
- Industry-standard user authentication protocols and methods
- Granular and intuitive user management with user roles segregated by duty
- Record and patient-level data protection
- Traceability of full record history, including invalid/altered record detection
- Generation of human- and machine-readable reports and exports
- Secure, computer-generated, time-stamped audit trails
- Definition of controlled user workflows for critical business processes
- Authority checks for generation & signing of electronic records & documents
- Input/output verification
- Continuous workflow verification
FAIR. ALCOA++. By Design.
Genedata solutions are engineered so you will meet FAIR and ALCOA++ guiding principles. The Genedata Biopharma Platform:
- Enhances organizational utility of data and metadata
- Includes advanced integration to enable machine and human readability of data
- Supports compliance features including audit trails, extensive user management, electronic signatures, and data security functionalities
- Enables capture of compliance-relevant information from diverse hardware and software systems enabled by its open architecture
Cloud Deployment. Validated.
Benefit from the flexibility of a cloud deployment while staying compliant with regulatory requirements. With a dedicated single-tenant installation, you have the control you need to manage risks and GxP compliance. Compliance features in Genedata software solutions, audit trails, and data security functions enable biopharma companies to use Genedata software solutions in SaaS-like deployments. Genedata experts support and collaborate with you throughout the project lifecycle to find the best solution. Contact our experts for details and advice.
Compliance Experts. Since 1997.
For over 25 years, Genedata has partnered with leading biopharma and biotech companies to digitalize and automate R&D processes. Our expertise in data integrity, privacy, and security is embedded in the solutions we build and is the foundation of our long-term success with our customers around the globe. Used across all stages of the drug development life cycle — including in regulated environments — Genedata solutions compliantly automate business processes, ensure data integrity and accuracy, reduce the burden of documentation, minimize compliance risks, and optimize organizational efficiency and agility.