Genedata Expressionist supports the entire workflow of integrated data processing, analysis, and interpretation from sample stage to result reporting for biomarker discovery and systems toxicology.
Filing data and results as electronic records, e.g. to support clearance of new drugs for marketing by the regulatory authorities, creates the necessity for an organization to achieve compliance with regulations such as 21 CFR Part 11.
21 CFR Part 11 requires both procedural and administrative controls to be implemented by an organization in addition to any technical controls that a vendor can offer. Genedata Expressionist Professional Services are available to assist in integrating Genedata Expressionist into the Standard Operating Procedures (SOP) of an organization in general, whether as part of a GxP validation process or 21 CFR Part 11 compliance.
Genedata Expressionist provides:
- Professional services for qualifying Genedata Expressionist within a validated environment and integrating Genedata Expressionist into the Standard Operating Procedures (SOP) of an organization;
- Data and results management based on Oracle’s enterprise strength Relational Database Management System (RDBMS);
- Secure audit trails per process and per authenticated user with proper time and date stamps;
- Workflow systems that facilitate the creation of repeatable and enforceable procedures and professional services which can help an organization with creating such workflows;
- Quality control of raw experimental data to high-quality processed data;
- Documentation to assist an organization in training its personnel in the use of Genedata Expressionist through on-site and web based training, printed and on-line documentation, and context sensitive help;
- Signature manifestation as defined by 21 CFR Part 11;
- Professional services to assist customers in meeting their electronic signature requirements using Expressionist within the customer’s defined Standard Operating Procedures (SOP).
Please request the Download on Genedata Expressionist and Professional Services support for compliance to 21 CFR Part 11 via Contact us.