Quality, Compliance, and Integrity.
Built-In.
Streamline and accelerate your drug development workflows while ensuring compliance at every step. Uphold the highest standards of data integrity and reliability — from secure data handling to fully traceable data and processes. With Genedata.
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.
21 CFR Part 11. 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 Audited. QMS in Place.
Designed to provide data integrity, security, and traceability, our platform incorporates scientific, domain-specific quality factors that are developed in-house by scientists, bioinformaticians, statisticians, software engineers, and quality professionals. Genedata software development and service processes are governed by a quality management system (QMS) based on 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.
Key Genedata features include:
- System access limited to authorized users, with industry-standard user authentication and granular, role-based user management
- Secure, computer-generated, time-stamped audit trails for traceability of full change history
- Technical checks and controlled workflows to prevent unauthorized data tampering
- Generation of human- and machine-readable reports and exports
- Definition of controlled user workflows for critical business processes
- Controlled data source and destination and continuous verification
FAIR. ALCOA++. By Design.
For over 25 years, Genedata has partnered with leading biopharmas and biotechs to digitalize and automate R&D processes. Our data integrity expertise is built into our software and forms the foundation of our success. Used across all stages of drug development, including in regulated environments, Genedata solutions are engineered around FAIR and ALCOA++ principles. They:
- Enhance organizational utility of data and metadata
- Include advanced integration to enable machine and human readability of data
- Enable capture of compliance-relevant information from diverse hardware and software systems, thanks to their open architecture
GxP. On Prem or in the Cloud.
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 on-prem or 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.
Advanced Technology. Proven in GxP.
We’ve pioneered the use of advanced analytical techniques in GxP environments such as NGS and mass spectrometry, application of digital technologies (AI/ML), and testing of advanced therapy medicinal products or novel modalities. Using this experience, we can guide you in adopting new approaches while maintaining regulatory compliance. As part of our long-term roadmap, Genedata software evolves with scientific and technological advances, while our disciplined approach to change minimizes regulatory risk.
Modular Validation. Minimized Effort.
Stay nimble and reduce re-validation burden. The modularity of Genedata software allows you to validate core features — including access control and system settings — separately from assay or modality-specific workflows. Additional workflows can be added one-by-one, so you keep building rather than start from scratch. The result? More efficient scaling of compliance operations, compounding return on validation investments, and faster adoption of and adaption to new technologies GxP environments.