Pinnacle 21 Enterprise's 6.4.0 release delivers a broad set of new features and improvements designed to help teams work more efficiently, collaborate more transparently, and maintain greater confidence in the quality and governance of their metadata and data package specifications. Across Metadata, Spec Designer, Data Exchange, Form Specs, and Define Designer, the focus is on reducing friction, improving visibility, and supporting regulated, real-world workflows without sacrificing flexibility.
One of the most impactful enhancements in this release is the expansion of workflow and governance capabilities. Request Assignments now extend beyond general tasks to include Data Package assignments, enabling clearer ownership and faster coordination across teams. For organizations working with external partners, the introduction of electronic approvals for External Vendor Data Package specifications represents a significant advancement.
These approvals include full audit trails aligned with 21 CFR Part 11, providing compliance-ready documentation, read-only snapshots, and finalized approval PDFs. Together, these capabilities help organizations formalize review and approval processes while reducing manual handoffs and documentation overhead.
This release also strengthens collaboration and visibility across teams. Real-time spec viewership indicators now show who else is actively viewing a specification, helping teams coordinate work and avoid conflicting edits. New Connected Metadata capabilities further enhance insight by allowing users to quickly understand upstream and downstream relationships across linked specs. This visibility is especially valuable when assessing change impact, promoting reuse, and maintaining alignment across standards, terminologies, forms, and study specifications.
For organizations with more advanced governance needs, the new Rule Designer introduces powerful flexibility. Teams can create and manage company-specific rules, view existing Pinnacle 21 rules, and control where rules apply across both data and metadata. Publishing and archiving workflows help ensure the right rules are available at the right time, supporting consistent interpretation of internal standards without hard-coding processes outside the platform.
A number of enhancements in this release focus on usability, clarity, and signal-to-noise reduction. Metadata comparison has been refined so that differences in terminology term order are no longer flagged as meaningful changes, helping reviewers focus on what truly matters.
Define Designer improvements make warnings more actionable by explicitly listing missing variables and suppressing issues when records are intentionally marked as having no data. Controlled Terminology browsing now includes NCI Preferred Terms, providing additional context to support informed terminology selection and review.
Form Specs also see meaningful expansion. New columns across Forms and Questions tabs provide richer detail for mapping, implementation, and review, while the introduction of an Issues tab brings consistent issue tracking into both global and study Form Specs. Optional Change Requests and the ability to copy global Form Specs help teams scale form management while maintaining appropriate levels of control.
Additional refinements across Spec Designer, Data Exchange, Administer, and Source Metadata further streamline everyday workflows — from clearer spec labeling and improved object selection to better filtering, validation warnings, and easier access to supporting notes. In addition to these new features and improvements, this release includes 34 bug fixes, delivering increased stability, accuracy, and polish across the platform.
Overall, this release continues to strengthen P21 Enterprise as a flexible, enterprise-grade solution — enabling teams to work with greater confidence, stronger governance, and improved efficiency as their metadata and data exchange needs evolve.
🧩 What this means for you
Faster, clearer collaboration: See who’s working in the same spec, understand connected metadata across systems, and coordinate changes with less back-and-forth.
Stronger governance with less overhead: Use request assignments, optional change requests, and electronic approvals to apply the right level of control — especially when working with external vendors.
More confidence in reviews and decisions: Cleaner comparisons, clearer warnings, richer terminology context, and reduced issue noise help teams focus on what truly matters.
Greater flexibility as you scale: Advanced capabilities like company-specific rules, extended specs, and reusable Form Specs allow you to adapt P21 Enterprise to your organization’s standards and processes.
A smoother day-to-day experience: Dozens of usability improvements and 34 bug fixes make everyday tasks faster, more intuitive, and more reliable.
🐾 Next Steps
Interested in learning more about P21 Enterprise and its advanced capabilities?