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Pharmaceutical QC & Manufacturing

Pharma QC & Weighing Systems

Precision weighing and QC machine integration built to support 21 CFR Part 11

Privya Solution LLP's Pharmaceutical Systems deliver precision dispensing, analytical balance capture, and turnkey integration for physical QC testing machines (Hardness, Disintegration, Friability, Leak Test), analytical meters (pH/DO, Gas Analyzers), and drying ovens with immutable ALCOA+ audit trails and eBMR generation.

Key Benefits

Why Businesses Choose This Solution

Built to support 21 CFR Part 11 and ALCOA+ data integrity standards
Direct integration with QC machines: Hardness, Disintegration, Friability, Leak Test & Ovens
Multi-parameter analytical meter interfacing: pH & Dissolved Oxygen (DO) and Headspace Gas Analyzers
Multi-balance integration for analytical, precision, and cleanroom floor scales
Part 11-ready electronic signatures, audit trails, and role-based access control
Elimination of manual transcription and calculation errors through direct API interfaces
Automated batch variance control with instant lock on out-of-specification (OOS) readings
Seamless bi-directional integration with LIMS, eBMR, and enterprise SAP ERP platforms

Pharma QC & Weighing Systems

Fully Customizable
Cloud Ready
Hardware Integration
Real-time Data

Core Features

QC Testing Machine Interfacing

Automated capture from Tablet Hardness Testers, Disintegration Testers, Friability Testers, Leak Test Apparatus, and Laboratory Ovens directly into batch records.

Analytical Balance & Sensor Sync

Direct RS232/USB/Ethernet integration with analytical balances, pH & DO meters, and gas analyzers across testing laboratories.

Precision Dispensing Workflows

Step-by-step dispensing workflow with mandatory tare, pre-weigh, and post-weigh verification at every stage.

Electronic Batch Records (eBMR)

Complete eBMR with automatic capture of QC machine readings, weights, operator ID, timestamps, and calibration certificates.

21 CFR Part 11 Compliance

Full electronic signature support, immutable audit trail, user access control, and ALCOA+ data integrity mandates.

Batch Variance & OOS Control

Theoretical vs actual batch parameter comparison with automatic deviation locks on any parameter exceeding tolerance.

Standardized Label Printing

Automated dispensing and sample labels with lot, quantity, operator, date, and unique QR/barcode dispensing IDs.

Sampling & LIMS Management

QC sampling workflows with sample identification, storage location tracking, and real-time LIMS synchronization.

Instrument Calibration Tracking

Schedule management for balances and QC testers with automatic blocking of uncalibrated instruments.

Audit-Ready Dashboard & Reports

Shift-wise QC summary, variance reports, compliance dashboards, and regulatory-ready inspection PDFs.

How It Works

1

Batch & Test Initiation

Production order or QC testing request received from ERP/LIMS with specification limits, BOM, and allowed variances.

2

Material & Machine Verification

Operator scans sample barcode, verifying test status, calibration validity of the target testing machine or balance.

3

Automated Instrument Interfacing

Target equipment (Hardness tester, pH/DO meter, Gas analyzer, Disintegration, Friability, Leak tester, or Oven) connects in real time.

4

Direct Zero-Keystroke Capture

Values captured directly into system buffer. Software checks against target recipe range and alerts immediately on deviation.

5

Electronic Batch & QC Record

Complete eBMR or QC certificate auto-generated with captured data, operator ID, dual e-signatures, timestamps, and calibration logs.

6

Compliance Sign-off & ERP Sync

Batch QC status verified, deviations logged, and released to packaging or warehouse only after authorized supervisor e-approval.

Industry Use Cases

Solid Dosage & Tablet IPQC

Hardness, disintegration, and friability capture

Eliminated manual paper logs and calculator errors — 100% digital IPQC release

QC Analytical Laboratories

pH / DO meter, gas analyzer & analytical balance capture

Cut sample test logging time by 50% with zero transcription defects

Sterile & Packaging Suites

Blister leak test apparatus & headspace gas validation

Guaranteed 100% seal integrity compliance with camera and vacuum logging

API & Chemical Synthesis

LOD oven thermal cycles and bulk ingredient dispensing

Reduced material variance from 2.1% to 0.3% across active batches

Nutraceutical Formulation

GMP dispensing & physical testing for dietary supplements

Built to support FDA audit readiness and ALCOA+ data integrity compliance

Veterinary Pharma

Revised Schedule M compliance for animal medicine manufacturing

Supported Schedule M digital alignment in 3 weeks post-implementation

Technology & Integrations

Tablet Hardness Tester IntegrationpH & DO Meter InterfacingHeadspace Gas Analyzer IntegrationDisintegration Tester IntegrationFriability Tester IntegrationLeak Test Apparatus Machine IntegrationLaboratory Oven & LOD InterfacingAnalytical Weighing Balance IntegrationRS-232 / USB / Modbus / TCP-IP21 CFR Part 11 & ALCOA+Schedule M (India) & GMP GuidelinesLIMS & SAP ERP IntegrationElectronic Signatures & Audit Trails
See It In Action

See it on your own workflow

Book a 30-minute demo using your products, devices and process.

Tailored 30-min live demoDirect hardware & ERP syncZero commitment required