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 — fully compliant with 21 CFR Part 11 and ALCOA+.
Client
Amneal Pharmaceuticals
Pharmaceutical Manufacturing
Business Challenges
All weighing records were handwritten, making regulatory audits difficult and creating data integrity risks during US FDA inspections.
Paper records could not satisfy electronic record and electronic signature requirements, leaving the facility non-compliant with GMP regulations.
Manual operator reading and writing of balance values introduced a 2–3% transcription error rate, causing batch rejections and costly rework.
Critical and high-potency materials had no enforced second-operator sign-off — a direct GMP protocol violation with no audit evidence.
How It Works
A fully digital, ALCOA+-compliant workflow — from batch setup to immutable audit log.
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System Capabilities
Electronic records and electronic signatures meeting US FDA data integrity requirements end to end.
Direct digital weighing scale connectivity via LAN, Wi-Fi, and RS232 — zero manual weight entry.
Tolerance check fires automatically on every stable weight reading — out-of-spec is blocked before the operator can proceed.
Configurable second-operator confirmation for critical materials — both operators authenticate before the record commits.
GMP batch record PDFs auto-generated with weights, timestamps, calibration data, and digital signatures.
Every action, edit, and login recorded with user ID, timestamp, and reason — fully attributable and tamper-proof.
Impact & Outcomes
Outcome
Amneal Pharmaceuticals now operates a fully GMP-compliant digital dispensing environment across all dispensing rooms. QualiWeigh eliminated all manual transcription, enforced 21 CFR Part 11 electronic records, and delivered a 30% throughput improvement. The facility passed its subsequent regulatory audit with zero data integrity findings.
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