As the third-largest animal health company in the world, The company develops and sells products and services that treat and prevent disease in animals – from companion pets to livestock at industrial scale. Behind every product that reaches a veterinary clinic or a farm is a rigorous, highly regulated manufacturing and quality assurance process.
At the heart of that process is paper. Specifically, batch records – Large file folders that travel with every product from raw material intake through manufacturing, quality review, packaging, and beyond. These are not simple files. They are living documents, continuously reviewed, signed off, and updated across dozens of checkpoints. And at client’s initial deployment site alone, there were approximately 70,000 of them.
The Challenge: Managing Records That Never Stop Moving
The client’s batch records follow products through a complex, multi-stage journey. From the moment raw materials enter the facility, folders are created, routed, annotated, and transferred between departments – manufacturing floors, QC labs, quality assurance teams, packaging lines, and regulatory review stations. At every stage, QC checks add new documents to the folder.
Once a product batch completes its lifecycle, its folder doesn’t simply disappear. It becomes an inactive record, archived in boxes, tracked by box, tracked within boxes, and eventually transferred offsite to secure long-term storage. With multiple global sites running the same processes simultaneously, the client was managing a records ecosystem of extraordinary complexity.
The problems that surface in such an environment are both predictable and painfully costly:
Location blind spots
No real-time view of which department held a folder at any moment. Retrieval meant phone calls, walking the floor, or waiting.
Audit vulnerability
Regulatory inspections require instant production of specific batch records. Manual systems created dangerous uncertainty.
Archive opacity
Once folders were archived into boxes and moved offsite, finding a specific record required laborious box retrieval and manual searching.
Time lost to searching
Staff spent 30–40% of their time searching for files — a systemic productivity drain across the entire organization.
Add to this the challenge of managing records across multiple global manufacturing sites – each with its own workflows, storage areas, and archiving timelines, and the need for a centralized, intelligent solution became undeniable.
The Solution: IoTFileTracker’s End-to-End Record Intelligence
The client selected IoTFileTracker – An enterprise-grade RFID and barcode-enabled file tracking platform developed by TrackerIoT. This brings full lifecycle visibility to its physical batch records. The platform was chosen for its depth of capability across the complete records management journey: from file creation and labeling through active tracking, archiving, offsite transfer, and eventual retrieval or destruction.
The deployment was not a simple software rollout. It was a comprehensive records management transformation, built on four interconnected pillars:
Precision Labeling and Digital Identity Registration
- Every batch record folder was assigned a unique barcode or RFID label, printed directly from the IoTFileTracker platform. These labels are not just identifiers, they are the digital handshake between a physical folder and its complete record in the system.
- Each label carries the batch number, product type, origination date, current workflow stage, and expected archival timeline. For Elanco’s hierarchical folder structure, master folders containing sub-folders for different process stages were used.
- IoTFileTracker supported hierarchical tagging, where sub-folders inherit their master folder’s location or are tracked independently when they separate for specialist review.
- Color-coded labeling by product line and year of origination further reduced misfiling risk and enabled visual identification without pulling folders from shelves.
Real-Time Tracking Across the Manufacturing Lifecycle
- RFID antennas installed throughout the facility – at doorways, in file rooms, at workstations, and along corridor checkpoints — continuously detect tagged folders and push live location updates to the IoTFileTracker dashboard.
- When a batch record folder leaves the QC lab for the packaging review station, the system logs the movement automatically, without any staff intervention. Check-out and check-in processes at workstations capture the destination, the reason for transfer, the responsible staff member, and the expected return date — building an unbroken chain-of-custody record.
- Motion sensors at file room doorways determine direction of travel, enabling fully automated check-ins and check-outs. Any unauthorized removal triggers immediate software, email, and SMS alerts to records managers and security personnel.
Intelligent Archive and Box-Level Tracking
- When a batch record completes its active lifecycle, IoTFileTracker manages the transition to archive with the same precision applied to active files.
- Folders are assigned to specific archive boxes, with IoTFileTracker printing specialized archive box labels that capture the box ID, contents list, retention schedule, and offsite transfer authorization.
- The system maintains a parent-child relationship between the box and every folder within it – so a search for a specific batch record returns not just the folder, but the exact box, shelf, and storage location where it resides, whether that’s onsite or at an offsite storage facility.
- Bulk check-in of entire carts of archived boxes is supported, dramatically accelerating the archival process when large batches of completed records are processed simultaneously.
Multi-Site Scalability and Enterprise Integration
- When a batch record completes its active lifecycle, IoTFileTracker manages the transition to archive with the same precision applied to active files.
- Folders are assigned to specific archive boxes, with IoTFileTracker printing specialized archive box labels that capture the box ID, contents list, retention schedule, and offsite transfer authorization.
- The system maintains a parent-child relationship between the box and every folder within it – so a search for a specific batch record returns not just the folder, but the exact box, shelf, and storage location where it resides, whether that’s onsite or at an offsite storage facility.
- Bulk check-in of entire carts of archived boxes is supported, dramatically accelerating the archival process when large batches of completed records are processed simultaneously.
Following the Batch Record: A Journey Through IoTFileTracker
To understand the practical impact, consider the journey of a single batch record folder through the client’s manufacturing process with IoTFileTracker in place
At every step, IoTFileTracker logs the timestamp, location, responsible person, and any annotations. The complete audit trail is available instantly — no manual reconstruction, no uncertainty, no searching. When a regulatory auditor requests a specific batch record, it can be located and retrieved in minutes rather than hours or days.
Compliance and Audit Readiness: The Pharmaceutical Imperative
For a pharmaceutical manufacturer operating under FDA, EMA, and GMP regulations, record integrity is not a best practice – it is a legal obligation. the client’s batch records are subject to inspection at any time, and the inability to produce a specific record on demand is a serious compliance failure with consequences that extend far beyond administrative inconvenience.
IoTFileTracker’s immutable audit trail – recording every movement, every access, every transfer – transformed the client ‘s audit readiness from a source of institutional anxiety into a demonstration of operational excellence.
The system’s electronic signature and PIN capture features ensure that sensitive records transfers are verified and accountable. The full inventory audit capability – achieved by simply walking a mobile RFID scanner through a storage area – allows the client to verify the presence and location of every record in minutes, generating instant discrepancy reports for any file that is missing or mislocated.
Measurable Outcomes
The business impact of IoTFileTracker at the client’s extended across productivity, compliance, and operational cost:
75%+
Improvement in file retrieval productivity through color-coded, RFID-enabled search
Minutes
Time to locate and retrieve any specific batch record, active or archived
Zero
Unaccounted file movements with every transfer logged automatically with full custody chain
Days → Hours
Full facility inventory audits reduced from days of manual work to hours of RFID scanning
Beyond the headline numbers, IoTFileTracker delivered something harder to quantify but equally valuable: organizational confidence. Quality managers, regulatory affairs teams, and plant directors could, for the first time, answer the question “Where is this batch record right now?” with certainty — from any location, at any time, across every site in the global network.
Why IoTFileTracker was the Right Fit for Pharma company
Pharmaceutical manufacturing presents unique demands that generic document management solutions cannot meet. IoTFileTracker’s design — developed over more than 40 years of records management expertise, with implementations across highly regulated government and commercial environments — addressed client’s specific requirements out of the box:
Regulatory-grade chain of custody
Every movement is logged with timestamp, user ID, destination, and reason — creating the kind of verifiable audit trail that satisfies FDA 21 CFR Part 11 and GMP documentation requirements.
Hierarchical record management
The platform’s native support for master folder and sub-folder hierarchies maps directly to the client’s batch record structure, where process sub-folders accompany the master batch record across different departments.
Seamless active-to-archive transition
The same platform manages both active file tracking and deep archive storage – including offsite box tracking helping eliminate the gap between operational records management and long-term retention that typically creates compliance blind spots.
Conclusion: A Model for Pharmaceutical Records Management
This deployment of IoTFileTracker represents a blueprint for how large-scale pharmaceutical manufacturers can bring order, compliance, and operational efficiency to the complex world of physical batch record management. Starting with approximately 70,000 records at a single site and expanding globally, the implementation demonstrated that even the most complex physical records ecosystems – spanning manufacturing floors, QC labs, quality review stations, archives, and offsite storage facilities, can be brought under complete, real-time control.
In an industry where a missing or unlocatable record can halt production or trigger regulatory action, IoTFileTracker delivered something that manual systems never could: certainty. Every folder, every box, every site is tracked effectively using the hardware and software features of IoTFileTracker
