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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. This stability program management solution delivers ICH Q1A stability guidelines compliance, FDA stability requirements alignment, GMP stability programs support, and AI-powered product shelf-life evaluation. Part of the AmpleLogic LIMS ecosystem.

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. Optimize analyst and instrument utilization, improve testing throughput, reduce sample turnaround time, and ensure regulatory compliance. Part of the AmpleLogic LIMS ecosystem.

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 — a life sciences MES platform and digital manufacturing platform delivering shopfloor execution system, GMP manufacturing software, cloud MES platform, AI-driven manufacturing insights, electronic batch manufacturing, weighing scale integrations, recipe management, real-time production monitoring, EE monitoring, batch manufacturing automation, and smart factory platform for pharma manufacturing digitalization.

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. Built on a robust aPaaS architecture, it unifies CAPA, deviations, change control, audits, OOS/OOT, complaints, risk assessment, vendor qualification, and lab incidents into a single closed-loop system with end-to-end traceability and audit readiness.

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 a pharmaceutical document management software purpose-built for regulated industries. This compliance document management system features controlled SOP management, document approval workflow software, AI-powered indexing, and regulatory-ready audit trails. Manage SOPs, policies, and controlled documents with document version control software, electronic signatures, and automated distribution.

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 is the best LMS for pharmaceutical companies — a 21 CFR Part 11 compliant LMS and GxP training software built as a cloud LMS for regulated industries. This life sciences training management software delivers automated training assignments, GMP training tracking, SOP training management, and pharma employee certifications with AI-powered learning intelligence across global sites.

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 is a purpose-built electronic logbook for pharmaceutical manufacturing that digitizes all logbook entries with electronic signatures, timestamps, and full audit trails. This equipment logbook software for pharma eliminates paper-based compliance risks with paperless logbooks in pharmaceutical manufacturing environments.

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, ensuring your instruments and equipment are always within specification.

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 and RIM software for pharmaceuticals — a pharmaceutical regulatory management software and regulatory information management system delivering life sciences regulatory information management, regulatory compliance management software, automated pharma regulatory workflows, regulatory content management, pharmaceutical product regulatory life cycle tracking, ANDA tracker, DMF tracker, and drug product lifecycle management from a centralized platform.

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 product quality analytics. Automate data collection, statistical analysis, and report generation for faster, more accurate quality reviews for Pharma, API manufacturers, CDMOs, Biotech, Biosciences, and CROs.

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, detect process drift proactively, and generate inspection-ready reports integrated with APQR workflows.

FDA Process Validation GuidanceICH Q8/Q9/Q10+3

UAM

User Access Management System

Secure, centralized user access control for regulated environments

AmpleLogic UMS is the ultimate solution for secure user access management, ensuring data protection and regulatory compliance. Centralize user access control across all systems with role-based permissions, audit trails, and automated provisioning.

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. Manage cleaning validation protocols, acceptance criteria calculations, and ongoing verification from a single system.

USFDAEU GMP Annex 15+3

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Data LakeAPQR

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