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Medical Device Case Study

Medical Device Maker Ensures 100% Compliance

Learn how a global Class II/III medical device manufacturer leveraged Micraft MES to digitize Device History Records (eDHR), enforce electronic signatures, and achieve audit-ready compliance—while accelerating lot release and improving quality.

  • Client: FDA-Regulated Medical Device Manufacturer
  • Category: Manufacturing Execution System (MES)
  • Date: 5th August, 2025
  • Industry: Medical Devices (Implants, Disposables)

Micraft MES unified production, quality, and compliance processes across three plants, delivering real-time visibility, complete traceability, and audit-ready records.

Challenge

Paper-based Device History Records (DHR) and manual in-process checks led to data entry errors, missing signatures, and delayed lot releases. The client needed a 21 CFR Part 11–compliant system that enforced right-first-time execution, ensured complete traceability (UDI), and simplified regulatory audits across multiple facilities.

  • Paper DHRs caused rework during audits and slow product release.
  • Lack of Part 11–compliant e-signatures & audit trails.
  • Limited real-time visibility into quality holds and nonconformances.
  • Inconsistent work instructions across 3 plants.
  • Prolonged CAPA cycles due to fragmented data.
  • Batch release delays affecting customer service levels.
Challenge

Solution

Micraft MES digitized end-to-end manufacturing and quality processes with eDHR, electronic signatures, automated checklists, and UDI/lot genealogy. Integrated quality workflows (NC, Deviation, CAPA) and real-time dashboards gave teams instant insight to act faster.

  • Part 11–compliant e-signatures with time-stamped audit trail.
  • eDHR with mandatory field validation & barcode/UDI capture.
  • In-process checks, SPC, and auto-holds on spec violations.
  • Integrated NC/Deviation/CAPA workflows with root-cause tools.
  • Seamless ERP integration for materials, lots, and CoC/CoA.
  • Role-based access, training enforcement & controlled work instructions.
Solution

Implementation

The solution was rolled out in three waves across sterilization, molding, and final assembly lines. eDHR templates were harmonized with QA/RA, and validation (IQ/OQ/PQ) was completed per GxP. ERP (SAP) and labeling systems were integrated for lot, UDI, and device master records.

Operators received role-based training; controlled copies of work instructions were pushed via MES terminals and tablets. Real-time synchronization ensured accurate material traceability and genealogy from raw materials to finished goods.

Validated Deployment

GxP validation (IQ/OQ/PQ) & Part 11 controls implemented.

Operator Training

Role-based training & read-and-understood acknowledgments.

UDI & Genealogy

End-to-end lot/serial tracking, barcode scans at each step.

Quality Workflows

NC/Deviation/CAPA embedded with RCA and approvals.

Key Features

Key Features Used

  • ✔ 21 CFR Part 11–compliant e-signatures & audit trail
  • ✔ eDHR with mandatory checks, barcode & UDI capture
  • ✔ In-process inspections, SPC charts & automatic quality holds
  • ✔ NC/Deviation/CAPA with 5-Why, Fishbone & effectiveness checks
  • ✔ Device Master Record (DMR) & controlled work instructions
  • ✔ Electronic Batch Records & sterilization parameter capture
  • ✔ ERP (SAP) & label management integration
  • ✔ Training management & role-based access control
  • ✔ Real-time dashboards for release status, defects & yields
  • ✔ Automated compliance & audit-ready reporting

Results

Within six months, the client achieved 100% eDHR completeness, accelerated lot release, and minimized audit risks—while improving first-pass yield and reducing CAPA cycle time.

  • 0 major audit findings in surveillance audit
  • 35% faster lot release cycle time
  • 40% reduction in CAPA cycle time
  • 99.8% traceability across materials, lots, and serials
  • Improved first-pass yield and reduced deviations

ROI

Micraft MES delivered payback within 10 months by eliminating paper, reducing deviations, and accelerating releases. The platform established a scalable, audit-ready foundation for future growth.

  • 60% reduction in paper & archival costs
  • 30% fewer deviations via enforced checks
  • 20% increase in QA productivity through eDHR review
  • Lower risk exposure & faster regulatory responses
  • Scalable blueprint for new product introductions (NPI)

Testimonial: “With Micraft MES, our eDHRs are complete and audit-ready. Lot release time has dropped dramatically, and we now have end-to-end traceability with compliant e-signatures.”