GAMP Solutions

Enterprise AI-Powered Solutions for Every Pharma Workflow

Comprehensive suite of validated software solutions for pharmaceutical, biotech, and life sciences organizations.

LIMS

Laboratory Information Management System

Streamline lab operations with a unified data management platform

AmpleLogic LIMS is an integrated solution for managing lab data, sample records, test tracking, customer services, and invoices. It ensures end-to-end traceability of lab workflows from sample receipt to result reporting, enabling faster turnaround times and regulatory compliance.

USFDA 21 CFR Part 11ISO 17025+3
Stability

Advanced Stability Management

Enterprise stability study management software for pharma shelf-life determination and regulatory compliance

AmpleLogic Advanced Stability Management is a purpose-built stability testing management system for managing the complete stability study lifecycle — from stability protocol creation and sample pull scheduling through chamber storage management, test execution, stability trend analysis and reporting, shelf-life determination, and expiry determination.

ICH Q1A-Q1FUSFDA 21 CFR Part 11 & 211.166+3
QC Planning

QC Planning & Scheduling

Intelligent planning and campaign-based execution for QC laboratories

AmpleLogic QC Planning & Scheduling transforms quality control laboratories with intelligent planning, automated scheduling, and campaign-based test execution.

USFDA 21 CFR Part 11EU Annex 11+3
eBMR

Manufacturing Execution System (MES / eBMR)

Pharma MES Software — Digital Manufacturing Platform for GxP Compliant Batch Manufacturing Automation

AmpleLogic is a purpose-built pharma MES software and pharmaceutical manufacturing software delivering electronic batch manufacturing, weighing scale integrations, recipe management, real-time production monitoring, and batch manufacturing automation.

USFDA 21 CFR Part 11EU Annex 11+3
eQMS

Electronic Quality Management System

Accelerate quality and compliance with an AI-driven, low-code platform for global regulatory readiness

AmpleLogic eQMS is an AI-driven quality management platform with 11 consolidated core modules. It unifies CAPA, deviations, change control, audits, OOS/OOT, complaints, risk assessment, vendor qualification, and lab incidents into a single closed-loop system.

USFDA 21 CFR Part 11ICH Q10+4
DMS

Document Management System

Electronic document management system with pharmaceutical document control and compliance

AmpleLogic's electronic document management system is purpose-built for regulated industries with controlled SOP management, document approval workflow software, AI-powered indexing, and regulatory-ready audit trails.

USFDA 21 CFR Part 11EU Annex 11+3
LMS

Learning Management System

Best LMS for pharmaceutical companies — AI learning management system for life sciences training management

AmpleLogic's pharmaceutical quality training software delivers automated training assignments, GMP training tracking, SOP training management, and pharma employee certifications with AI-powered learning intelligence.

USFDA 21 CFR Part 11EU Annex 11+3
eLogbook

Electronic Logbook for Pharmaceutical Manufacturing

GMP compliant electronic logbook system — replace paper logbooks with compliant digital records

AmpleLogic Electronic Logbook digitizes all logbook entries with electronic signatures, timestamps, and full audit trails, eliminating paper-based compliance risks.

USFDA 21 CFR Part 11EU Annex 11+3
CAPS

Calibration & Preventive Maintenance System

Optimize calibration and preventive maintenance schedules

Optimize Calibration and Preventive Maintenance with CAPS! It comes with superior features like calibration scheduling, forecasting, real-time & colour-coded alerts.

USFDA 21 CFR Part 11ISO 17025+3
RIMS

Regulatory Information Management System

Simplified Regulatory Information Management for Faster Compliance

AmpleLogic RIMS is a purpose-built regulatory information management software delivering regulatory compliance management, automated regulatory workflows, and drug product lifecycle management.

ICH eCTDUSFDA+3
APQR

APQR - Annual Product Quality Review

AI-assisted product quality analytics and automated report generation

AmpleLogic APQR software transforms product quality review with AI-assisted analytics. Automate data collection, statistical analysis, and report generation for faster, more accurate quality reviews.

ICH Q7USFDA+3
CPV

Continued Process Verification

Real-time CPP/CQA monitoring and automated statistical analysis for Stage 3 validation

AmpleLogic CPV software ensures ongoing process control during commercial manufacturing. Monitor CPPs and CQAs in real-time, automate statistical analysis, and detect process drift proactively.

FDA Process Validation GuidanceICH Q8/Q9/Q10+3
UAM

User Access Management System

Secure, centralized user access control for regulated environments

AmpleLogic UAM is the ultimate solution for secure user access management, ensuring data protection and regulatory compliance across all systems.

USFDA 21 CFR Part 11EU Annex 11+3
CVS

Cleaning Validation Software

Ensure product quality through validated cleaning processes

AmpleLogic Cleaning Validation Software ensures product quality and compliance by evaluating cleaning processes in life science industries.

USFDAEU GMP Annex 15+3
Solution Integrations

Low Code aPaaS for Life Sciences — Unified Integration Architecture

AmpleLogic's modules don't operate in silos. Every solution is interconnected — sharing data, triggering workflows, and maintaining a single source of truth across Quality, Manufacturing, and QC Laboratory functions.

AmpleLogic Solution Integrations — data flow across eQMS, LIMS, eBMR, DMS, LMS, CAPS, APQR, QC Planning, eLogbook, RIMS, Cleaning Validation, UMS and Data Lake

How AmpleLogic modules integrate across Quality, Manufacturing, and QC Lab functions in pharmaceutical companies

Unified Data Lake

All modules feed into a centralized Data Lake, enabling real-time performance indicators, quality metrics, and cross-functional analytics without manual data consolidation.

Automated Workflow Cascades

A single event — such as a deviation in manufacturing — automatically triggers CAPA in eQMS, document revision in DMS, retraining in LMS, and impact assessment in APQR.

Bi-directional Data Flow

Data flows in both directions between modules. For example, LMS sends training effectiveness records back to eQMS, and LIMS returns analytical results to eBMR for batch release.

How Integrations Work Across Functions

Quality Management

eQMSDMSLMSAPQRUMS

The Quality Management ecosystem ensures every deviation, CAPA, change control, and audit finding is tracked end-to-end. eQMS sits at the center — triggering document workflows in DMS, training assignments in LMS, and feeding statistical data into APQR for annual product quality reviews.

eQMSDMS
New / Update Document

When a deviation or change control is raised in eQMS, DMS automatically initiates an SOP revision workflow, ensuring documents stay current with every quality event.

eQMSLMS
Training Needs

New or revised SOPs trigger automatic training assignments in LMS. Training effectiveness records flow back to eQMS to close the quality loop.

Data LakeAPQR
Statistical Analysis

Batch data, deviations, CAPA records, and process parameters are aggregated in the Data Lake and fed into APQR for comprehensive annual product quality reviews.

CAPSAPQR
QMS + Training Data

Calibration deviations and preventive maintenance records from CAPS flow into APQR, providing a complete picture of equipment and instrument impact on product quality.

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