LabConnect
Real-Time Instrument Connectivity & Digital IPQC Platform for Pharmaceutical Manufacturing
A precision IPQC and dispensing platform for Amneal Pharmaceuticals. Connects directly to weighing balances via LAN, enforces real-time tolerance checks, routes critical materials through dual-operator verification, and generates tamper-proof electronic batch records — built to support 21 CFR Part 11 and ALCOA+ data integrity.
Client
Amneal Pharmaceuticals
Pharmaceutical Manufacturing
Business Challenges
Problems We Solved
Paper-Based Batch Records
All weighing records were handwritten, making regulatory audits difficult and creating data integrity risks during US FDA inspections.
Electronic Record Gaps
Paper records could not satisfy electronic record and electronic signature requirements, creating data integrity risks under regulatory standards.
Transcription Errors
Manual operator reading and writing of balance values introduced transcription risks, causing batch rejections and costly rework.
No Dual-Operator Validation
Critical and high-potency materials had no enforced second-operator sign-off — leaving room for unverified dispensing steps.
System Capabilities
Core Features
Built to Support 21 CFR Part 11
Electronic records and electronic signatures built to support US FDA data integrity requirements end to end.
Digital Weighing Scale API
Direct digital weighing scale connectivity via LAN, Wi-Fi, and RS232 — zero manual weight entry.
Real-Time IPQC Validation
Tolerance check fires automatically on every stable weight reading — out-of-spec is blocked before the operator can proceed.
Dual-Operator Verification
Configurable second-operator confirmation for critical materials — both operators authenticate before the record commits.
Electronic Batch Records
Batch record PDFs auto-generated with weights, timestamps, calibration data, and digital signatures.
ALCOA+ Audit Trail
Every action, edit, and login recorded with user ID, timestamp, and reason — fully attributable and tamper-proof.
Impact & Outcomes
Results Delivered
Outcome
Amneal Pharmaceuticals operates a digital dispensing environment across all dispensing rooms. LabConnect eliminated manual transcription, enforced Part 11-ready electronic records, and delivered a 30% throughput improvement with verified data integrity.
See it on your own workflow
Book a 30-minute demo using your products, devices and process.