Issue Management

“I’m a biostatistician who uses Pinnacle 21 Community to generate validation reports for SDTM and other data packages. Isn’t Issue Management within Pinnacle 21 Enterprise just a web-based method of generating that same report?” 

Pinnacle 21 Community is a powerful resource for capturing most rule violations in a data package. The Excel-readable output lends itself to easy filtering, sorting, and (with a few formulas) basic analysis. It’s a great starting point we’re proud to offer at no cost. 

However, issue reporting is only the first step in issue management, where the goal is resolution. Validation reports from Community do not provide any of the essentials for collaboratively assessing, assigning, and correcting issues according to a set of best practices for accuracy and consistency. 

What you won’t find in a Community-generated validation report: 

❌ A fine-grained indication of a given issue’s severity (only a flag if that issue will trigger a technical rejection by the regulatory authority) 

❌ Progress and data fitness scores with benchmarks 

❌ Recommendations for resolution generated by our submission experts 

❌ Centralized triaging of issues to other stakeholders for correction 

❌ A date-stamped audit trail of corrective actions taken for each issue  

❌ A “living memory” of explanations offered for discovered rule violations, for reuse 

❌ Human readable snippets of the offending records for easy triangulation 

Without these tools, you’re left to design and implement your own resolution process. Despite clear instructions and team buy-in at the outset, we’ve seen this devolve into messy Excel sheets and long email threads too many times, where clashing ideas of “priority” and “recommended actions” introduce delay and inconsistency. 

Issue Management in Pinnacle 21 Enterprise offers a better way. 

What Issue Management in Pinnacle 21 Enterprise provides: 

✅ A review impact grade for each detected rule violation — Reject, High, Medium, or Low — so you can prioritize corrections needed beyond those that would trigger rejection 

✅ The fitness score change (e.g. +21) you can expect upon correction of any set of issues, so you can move quickly from “acceptable” to “perfect” 

✅ Rule-specific Fix Tips: paths to resolution authored by Pinnacle 21 subject matter experts and your own team 

✅ Drop down menus for:  

✅ Issue status (e.g. Open, Closed, Fix Now, Fix Later),  

✅ Assignee (e.g. Julie, Data Manager), and  

✅ Source (e.g. Mapping) 

✅ For unfixable issues, a history of rule-specific explanations you can reuse for new issues and bring into your Reviewer’s guide 

✅ A date-and-time-stamped comment board for every issue 

✅ A complete history of validation runs and their results 

These capabilities, all delivered via a cloud-based UI, save weeks of backtracking through locally (and disparately) saved spreadsheets, only to find scant intelligence on who did what and why. 

In short, Pinnacle 21 offers moment-in-time reporting of validation issues, leaving resolution up to you. Pinnacle 21 Enterprise, on the other hand, functions as a purpose-built project management tool guiding you toward that resolution, with a perfect and detailed memory to leverage for future packages!