OpenNovations has extensive experience both in IT systems development as well as in guiding clients through computerized systems validation processes. Over the years our team has supported many clients during FDA (Food and Drug Administration) / EMA (European Medicines Agency) inspections. This experience has been bundled into the Aranei software stack.
Change and release management
Maintaining a computerized systems validated state is time consuming, tedious and requires a continuous alignment between both business process management, information management, QA, and IT. OpenNovations recognizes and understands the need for clients to simplify and lessen the burden of this process of continued change through standardized and (mostly) automated development, testing, validation, and release processes.
As part of every change within the data model or logic of the app, a full set of automated tests is generated alongside the app.
This set of automated tests covers every aspect of the functionality of the application. Including data input validation, user roles/permission checks, workflow logic, data integrity verifications, etc.
The test suite covers both the happy flow of the application as well as deliberate out-of-bounds inputs to verify the system’s safeguards against malicious or abnormal/unintended use. The automated tests also cover cybersecurity scanning of the deployed platform.
open source, security, privacy, development, validation, architecture, infrastructure
Automated testing and validation
During the initial implementation phase, and on subsequent releases, of an Aranei implementation OpenNovations aligns closely with the client’s QA department to ensure specific regulatory compliance needs are covered.
OpenNovations works with clients in all GxP domains and strictly adheres to the FDA endorsed ISPE (International Society for Pharmaceutical Engineering) GAMP5 guidance for computerized systems development and validation.
GAMP5 combines relevant requirements from all GxP domains, including ICH GCP E6 (R2), OECD GLP, EU/Intl GMP Annex 11, and other relevant regulatory requirements.
This approach ensures maintaining a validated state of the application throughout the lifecycle which guarantees the client continuous inspection readiness of any aspect of their Aranei deployment.
Key elements of Aranei regulatory compliance approach
- Change and release management in collaboration with your QA department and end users
- Automated testing and validation
- Full auditability of both development, deployment and daily operations
Auditability
All actions are logged, and an auditable human readable history is stored for every action. The audit trail conforms to the requirements defined by 21 CFR Part 11 and other relevant regulations. These detailed audit trails can also be made available to other applications through the REST API.
Aranei keeps an archive of any change to any record in the system, allowing clients to go back to certain point in time to recreate datapoints and circumstances that influenced studies, trials, sample tests or any other point of a clients’ decision-making process.
Aranei offers system users a live feed of any relevant update on records within the system that are of relevance to them, using either the UI directly or third-party services like team chat apps or email.
Authentication and authorizations
Users and profiles are managed centrally from the identity management (Active Directory compatible) system.
Aranei implements principles of both Role Based Access Control as well as Attribute Based Access Control. Allowing a client fine-grained control over any aspect of data confidentiality, integrity and availability.
Authorization management and data filtering is possible on process/workflow-step, datasheet (table) or even field-level.
Data preservation and archiving
Aranei can also be used for digital record preservation and archiving following ALCOA+ principles
Keeping data alive as opposed to petrification is a proven safeguard against all kinds of digital data decay. With its flexible data structure capabilities, Aranei is a perfect fit for any such a living archive application.
The flexibility of the Aranei relational database approach allows for having specific parts of any dataset to be marked as archived and therefore read-only.
While maintaining the availability of such data within the app for future reference, any alterations of such data is prohibited.