In a complex and multi-tier development environment, the efficient and transparent management of approval processes is far from trivial. codeBeamer ALM's Review Hub enables you to implement fully traceable, paperless approval processes with real-time access for all stakeholders.
With many contributors and reviewers working on volumes of work items, maintaining order in your sign-off procedures can be a huge challenge. Yet all comments, change requests, and timestamped approvals need to be tracked and logged accurately in order to ensure traceability. That's especially true in the context of safety-critical product delivery or where the management of computerized systems is key, as in pharmaceutical project management. codeBeamer ALM's updated Review Hub functionality helps product development teams tackle these challenges.
Review Hub: Transparency & efficiency in approval management
codeBeamer ALM, the premier development platform for safety-critical product innovation, brings updated capabilities for boosting approval management. For product developers building complex and integrated systems, codeBeamer ALM’s Review Hub provides enhanced auditability and e-signature management for FDA Title 21 CFR Part 11 compliance.
The popular Review Hub feature set provides a transparent and efficient dashboard for unlimited stakeholders to manage approval processes. The Hub provides easy access to a shared review platform, enabling users to manage sign-offs in a fast, transparent, and fully collaborative way. Reviewers get an easy-to-overview interface to manage all the items waiting for their approval, while the Hub tracks any and all review activities on those items. The system uses timestamped, human-readable e-signatures to ensure regulatory compliance.
“The primary value of codeBeamer ALM has always been that it helps cut the time and costs of project lifecycles significantly” says Anita Solymosi, Intland Software's GAMP®5 Validation Expert. “The Review Hub greatly contributes to that benefit, enabling teams to reduce the time they spend on endless approval meetings. Instead, they can define sophisticated approval workflows and use 21CFR11-compliant e-signatures to accelerate and simplify collaborative approval management.”
Using codeBeamer ALM’s Review Hub, users can easily embed mandatory approval gates in complex product development workflows. This ensures failproof review management, blocking subsequent workflow steps if the necessary approvals are lacking. Notifications help ensure quick response times and transparency in review management. The Show Review Results widget makes it simple to report on the approval process, guaranteeing smooth compliance assessments where
The updated Review Hub provides users with:
Advanced workflows to simplify approval setup and control
Users enjoy consistency and clarity in setting up and conducting reviews on work items and processes. Triggered notifications and a shared, central approval hub help boost collaboration in review management.
The Review Hub ensures a simple path to regulatory compliance (including FDA Title 21 CFR Part 11 and GAMP®5 ) with human-readable, electronically recorded and timestamped reviews, and a full audit log of approval activities. Full compliance support is provided for users developing regulated products like automotive or avionics embedded systems, medical devices, and pharmaceutical projects. The Review Hub’s audit trail helps demonstrate adherence to relevant regulatory standards.
Automating review processes
By enhancing review processes, codeBeamer ALM's Review Hub enables product teams to deliver better quality products with fewer errors along the lifecycle. The automation of approval procedures contributes to a reduction in time to market, while automatically logged review data helps auditors simply confirm the maturity of approval processes.
Simplify product validation, and provide your stakeholders with better monitoring, control, and reporting over review processes. Provide real-time access to approval information, and shorten your project lifecycles in a paperless environment while maintaining full traceability. Try codeBeamer ALM today to find out more about how your teams could benefit from using the updated Review Hub!