See how ARDEM cleared an approximately 75,000-record Tissue Utilization backlog within a few months and supported approximately 6,000 forms per week through manifest control, digitization, dual-entry capture, programmatic validation, exception review, and secure archival return.
REGULATED TISSUE UTILIZATION RECORDS CASE STUDY
Clearing a Tissue Records Backlog and Sustaining 6000 Weekly Forms
75,000
Backlog cleared
~6,000/week
Ongoing forms
3
Form variations
Dual entry
Validation control
Overview
A biomedical pharmaceutical company needed FDA-mandated Tissue Utilization Records to remain current, traceable, and accessible. The engagement combined an approximately 75,000-record historical backlog with an ongoing profile of roughly 6,000 forms per week across three form variations containing patient, facility, provider, procedure, implant-date, and Tissue ID information.
The Challenge
Forms could combine handwriting, printed text, stickers, small labels, barcodes, unclear characters, and multiple Tissue IDs, with field-specific rules determining which source value took precedence.
The original physical records also had to remain traceable by box through receipt, digitization, processing, secure repacking, return, and archival storage.
The ARDEM Solution
ARDEM created an end-to-end regulated records operation around box manifests, controlled scanning, rule-based extraction, independent dual-entry capture, automated character-level comparison, analyst exception review, validated delivery, expedited support, and secure archival return.
Human judgment remained part of the workflow for unclear handwriting, identifier conflicts, multiple Tissue IDs, and rule-specific source decisions that could not be resolved safely through automation alone.
Download the Full
Tissue Utilization Record Processing
Case Study
Tissue Utilization Record Processing
Case Study
For life sciences operations leaders, healthcare records teams, quality and compliance leaders, project managers, and organizations managing regulated paper-to-data workflows.
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Why ARDEM
Box-level manifests established traceability from receipt through archival return.
Documented priority rules guided patient, provider, procedure, implant-date, and Tissue ID extraction.
Two separately captured records reduced dependence on one operator interpretation.
Character-level validation surfaced actual mismatches for focused review.
Analysts handled unclear handwriting, blurred identifiers, multiple IDs, missing values, and rule conflicts.
Validated output, expedited requests, repacking, return, and post-return purge closed the records-control loop.Managed Workflow Diagram
The Results
ARDEM processed an approximately 75,000-record Tissue Utilization backlog within a few months and supported recurring volume of approximately 6,000 forms per week. Box manifests, controlled digitization, field-specific capture rules, independent dual entry, programmatic character-level comparison, analyst exception review, secure repacking, archival return, and expedited support created a connected operating model for keeping regulated records current while preserving tissue-level traceability and physical-record control.
The 75,000-Record Backlog Was Only the Visible Problem
The Larger Risk Was Losing Tissue-Level Traceability While Trying to Catch Up
The client did not only need backlog reduction. Each regulated record had to preserve the link between physical forms, captured data, and one or more Tissue IDs while applying field-specific interpretation rules.
Adding manual keying capacity without manifests, dual-entry comparison, exception logic, and secure archive controls could reduce the backlog while weakening record quality or physical traceability.
The workflow needed one managed control model spanning receipt, digitization, validation, exceptions, delivery, and archival return.
ARDEM cleared an approximately 75,000-record historical backlog within a few months and supported ongoing volume of approximately 6,000 Tissue Utilization forms per week through a controlled records workflow combining box manifests, digitization, dual entry, programmatic comparison, analyst review, and secure archival return.
1
Manifested Intake
Create box-level traceability before processing begins.
2
Digitization
Scan three form variations while preserving processing order.
3
Rule-Based Capture
Apply documented field and source-priority rules.
4
Dual-Entry Validation
Create two independent records for comparison.
5
Exception Resolution
Review mismatches, unclear identifiers, and rule conflicts.
6
Delivery and Secure Return
Deliver validated data and return originals for archive.
What You’ll See in the Full PDF
The full case study explains:
- How box manifests established physical record traceability
- How field-specific rules handled stickers, handwriting, NPIs, dates, and Tissue IDs
- How dual-entry capture and character-level comparison surfaced discrepancies
- How analysts resolved unclear handwriting, blurred identifiers, and multiple Tissue IDs
- How expedited record support fit inside the recurring workflow
- How secure repacking, return, and post-return purge closed the control loop
Is Regulated Record Volume Growing Faster Than Your Validation and Archive Controls?
Download the case study to see how a managed records workflow can combine backlog recovery, recurring capacity, source interpretation, dual-entry validation, and secure physical handling.