Compliance. Integrity. Quality. Built-In.
Our Customers
To ensure product quality, patient safety, and efficacy of drug products, biopharmaceutical companies must rigorously validate processes. Software solutions used in drug development and manufacturing must guarantee data integrity, privacy, and security to meet the expectations of regulatory agencies such as the FDA and EMA. As companies navigate the road to compliance for new processes, they need a partner who understands data governance pitfalls and digital best practices.
This is where Genedata comes in.
Genedata developed the end-to-end oligonucleotide QC data workflow and provided the consulting expertise through the entire project including the validation stage to help us achieve our goals on time and on budget.
The Genedata Profiler platform is used productively in a validated environment and is helping to democratize access to integrated data in the translational research and clinical settings
Digitalization 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 automate business processes to increase accuracy, reduce the burden of documentation, and optimize organizational efficiency and agility.
Industry Standards. Applied.
To facilitate the deployment of our solutions in regulated environments, Genedata software is 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)
Compliance Support. 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
- 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
SOC2 Compliant. ISO 9001 Next.
Designed to provide data integrity, data security, and traceability, our platforms have scientific domain-specific quality factors built in and are developed in-house by scientists, bioinformaticians, statisticians, software engineers, and quality professionals. Genedata's daily processes are aligned with ISO 9001 requirements and information is operated and protected within a full information security framework. To ensure our security controls and processes are compliant, our information systems and processes are externally audited and Genedata has been awarded a SOC2 Type 2 certification.
FAIR. ALCOA+. By Design.
Genedata solutions are engineered so our customers meet FAIR and ALCOA+ guiding principles. The Genedata platform:
- Enhances organizational utility of data and metadata
- Includes advanced integration to enable machine & human readability of data
- Supports compliance features including audit trails, extensive user management, digital signatures, and data security functionalities
- Enables capture of compliance-relevant information from diverse hardware and software systems due to its open architecture
Road to Compliance. Together.
With increasingly strict regulatory requirements and evolving risk identification capabilities, the compliance journey requires close collaboration to identify and support specific business processes. Genedata offers a tailored approach to ensure smooth alignment with quality and compliance requirements. Genedata’s in-house experts have extensive experience in developing, deploying, and managing biopharma systems in regulatory environments. Our flexible quality management system (QMS) processes are built to optimally support customer validation projects and include comprehensive documentation, full traceability from requirements to test, and professional training.