In the medical device and pharmaceutical sectors, production doesn't end when the product leaves the assembly line—it ends when the paperwork is cleared. For many operations leaders, the Device History Record (DHR) review is a manual, paper-heavy process that can keep finished goods sitting in a warehouse for days or even weeks.
At Automation & Engineering Solutions, we specialise in helping life science companies move away from these legacy bottlenecks. By leveraging the Regulated Industries tier of the Tulip platform, you can implement AI-powered Review by Exception, potentially saving hundreds of hours and accelerating your time-to-market.
The Hidden Cost of Manual Reviews
A traditional DHR review requires a quality staff member to manually flip through hundreds of pages of logs, signatures, and sensor printouts to ensure every step was followed correctly.
- Human Error: Manual reviews are prone to oversight fatigue, where subtle deviations are missed simply because of the sheer volume of data.
- Delayed Revenue: Every day a batch spends in review status is a day it isn't generating revenue.
- Excess Storage: Physical paper records require climate-controlled storage and complex indexing for audit readiness.
What is Review by Exception?
Review by Exception (RBE) is a digital-first strategy where the system—rather than a human—monitors the production data in real-time. Because Tulip acts as a connected digital system, it knows exactly what the ideal process looks like.
Instead of reviewing every single data point, your quality team only reviews the exceptions:
- Automated Flags: If a temperature sensor drifts out of range or an operator skips a mandatory step, the AI flags that specific event immediately.
- Real-Time Guardrails: Tulip’s logic can prevent a batch from moving to the next stage if a critical parameter hasn't been met, effectively self-auditing as you go.
- Electronic Signatures: Secure, time-stamped signatures are captured at every critical step.
- Audit Trails: The system automatically tracks every change, who made it, and why, providing a clean record for inspectors.
- Data Integrity: By pulling data directly from hardware—like multimeters or scales—you eliminate the risk of manual transcription errors.
Ensuring Local Industry Remains Globally Competitive
Moving to an AI-powered review process isn't just about saving time; it's about shifting your quality team from detecting mistakes to preventing them. As qualified engineers, we understand the pressure of maintaining these standards while trying to remain competitive.
Reach out to the experts at Automation & Engineering Solutions today to learn how implementing a digital DHR strategy with Tulip ensures your facility is not just meeting today's standards, but is ready for the Digital 5.0 future of manufacturing.