Are Your Logbooks in Place For The Upcoming Audit?
As a pharmaceutical manufacturer, you are likely familiar with the stringent regulatory requirements governing the industry. One critical aspect of compliance is o maintain accurate
AmpleLogic eLogbook
Electronic Logbook Software
Digitize Your Operations with AmpleLogic e Logbook
Digitize Logbook Journey in Lifesciences
Managing data in regulated industries can be fraught with challenges, from compliance issues to the risk of human error in manual systems. AmpleLogic’s eLogbook transforms data management across regulated industries like Life Sciences, Food & Beverages, Cosmetics, Gene Therapy, and Medical Devices. Our web-based digital logbook replaces error-prone, manual systems with a modern, compliant, and efficient digital solution while ensuring transparency across the entire production process and QC labs.
Automated Log Tracking
Detailed logs for calibration, maintenance, equipment cleaning, and investigations
Document Management
Efficiently manage documents, SOPs, and records to reduce errors and data loss
Area Monitoring and Control
Implement monitoring and control for cleanrooms and production zones
SOP Management
Handles document issuance, training attendance, and SOP retrieval
Expertly crafted to convert manual paper forms into accurate, digital equivalents, it ensures compliance with major regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, MHRA, GAMP, GMP, and ISO. This innovative software streamlines logbook entries for operational departments—including quality, production, planning, and maintenance, while facilitating real-time validation, review, and approval through customizable workflows.
Eliminate Manual Logging Pitfalls with AmpleLogic eLogs
In the pharmaceutical industry, traditional log management is riddled with pain points—manual data entry errors, missing logbooks, compliance risks, and time-consuming paper processes that hinder productivity and regulatory adherence. These inefficiencies not only disrupt operations but also heighten the risk of non-compliance, leading to costly penalties and delays in audits or inspections.
AmpleLogic’s eLogbook Software provides a comprehensive solution by automating log management, enabling real-time monitoring of processes, and ensuring data integrity with secure, easily accessible digital records. It minimizes human error, reduces the need for manual data entry, and provides multilingual support to meet diverse workforce needs. With automated alerts, reduced downtime, better resource allocation and customizable reports, the platform simplifies compliance and allows businesses to focus more on core operations.
Why choose AmpleLogic Electronic LogBook?
In an era of evolving regulations and complex manufacturing processes, AmpleLogic eLogbook stands out as the solution of choice. Our state-of-the-art software ensures essential data is disseminated throughout the organization’s essential operational departments to bring clarity and transparency to the entire organization’s production.
Enhanced Traceability
Complete transparency and accountability across all operational processes.
Integration with 3rd-Party Applications
Track schedules, due dates, and activities effortlessly with a calendar display
Cost-Effective & ROI-Focused
Streamlined processes lead to significant savings and fast returns on investment.
Visibility and Validation of Equipment
Ensures clear visibility of usage logs and validation conditions for equipment and manufacturing facilities.
Streamline Data Management with AmpleLogic e Logbook
Unlock full potential of AmpleLogic Electronic logbook (eLogbook) with these key features
Competency Records
Maintain comprehensive records of employee training and competency assessments to ensure a skilled and compliant workforce.
Equipment Data
Schedule and receive alerts for preventive maintenance to maximize equipment uptime and longevity.
Area Data
Integrate sensors for real-time monitoring of temperature, humidity, and particulate levels in cleanrooms and production zones.
Maximum Traceability
Track all operational processes from start to finish for complete visibility and accountability.
Equipment Usage and Maintenance
Analyze equipment performance data against industry standards to identify improvement areas.
Notification and Escalation Features
Automatically sends alerts for expiring logs, ensuring timely updates and assessments.
Area Monitoring and Control
Implement user access controls to restrict unauthorized entry into sensitive manufacturing areas.
Cleaning and Alarms
Trigger cleaning schedules based on usage frequency and regulatory requirements, ensuring compliance.
Roles and Departments
Customize logbook access and permissions based on role-specific needs across different departments.
Version Control
Maintain a detailed log of document changes, providing a clear audit trail for regulatory compliance.
Enhanced Analytics
Utilize dashboards and graphs to visualize data trends and performance metrics effectively.
System Integration
Seamlessly integrate with other enterprise systems (ERP, MES) for streamlined data sharing and enhanced operational efficiency.
Automated Notifications
Set personalized notifications for critical tasks, ensuring timely responses and actions.
QR & Barcode Scanning
Use QR/barcode scanning for real-time inventory tracking and management.
Verification
Implement verification processes for equipment, rooms, and solutions before they are utilized to maintain compliance.
Document Management
Access a library of templates for SOPs and compliance documents to streamline documentation efforts.
Customizable Reports
Generate tailored reports based on specific roles and departmental needs, providing targeted insights.
Data Integrity
Incorporate redundancy protocols to ensure data recovery and integrity in case of system failures.
Workflow Automation
Automate task assignments based on user roles and workload balance, enhancing efficiency.
Calendar View for Logs
Displays log data in a calendar format for easy tracking of schedules and due dates.
Configurable Log Reports
Allows users to generate tailored reports in formats like PDF, CSV, or XML to meet specific needs.
Create Audit Trails
Maintain detailed logs of all user activities and system changes for thorough audits.
User-friendly Interface
Features an easy-to-navigate interface that minimizes the learning curve for new users.
Facilitates Verification
Ensure all necessary documentation is reviewed and approved before equipment usage.
Smart Reports
Schedule automated report generation to provide timely insights to stakeholders.
Interactive Dashboard
Users can customize dashboard views to focus on the metrics most relevant to their roles.
Interlocking
Implement safety interlocks for equipment and processes to prevent unauthorized or unsafe operations.
Access from Any Device
Access the eLogbook from any device with internet connectivity for flexibility and convenience.
User Tracking
Analyze user behaviour to improve system usability and identify training needs.
Offline Access
Ensure data entered offline syncs automatically when connectivity is restored.
Compliance Assurance
Schedule regular internal audits to assess compliance with industry regulations.
Web-Based Logbook Software
Experience seamless access and real-time updates with our web-based Digital Logbook Software solution, enhancing operational efficiency.
Logbook Entry Upload/Download
Facilitates uploading and downloading log entries in authorized formats, including customizable templates.
Automated Compliance Management
Automatic notifications and workflows ensure timely validations and updates.
The AmpleLogic eLogbook Software / Electronic Logbook guarantees that information is disseminated throughout the organization’s essential operational departments including the quality, production, planning, and maintenance departments; and they serve to bring clarity and transparency to the entire organization’s production and QC lab activities.
AmpleLogic’s Electronic Logbook Software helps in the configuration of different types of logbooks.
Area and Equipment Logbook
| Equipment Usage logbook | Boiler Operation logbook |
| Environment Condition | HPLC Usage logbook |
| Calibration Logbook | AHU Parameter Monitoring |
| Chiller Operation logbook | HEPA Filter Replacement |
| Purified Water Distribution | Air Compressor Monitoring |
| Semi-Micro Balance log | TDS Analyzer logbook |
| Pressure Monitoring | Melting Point Apparatus |
| Electrical Substation Operation | Maintenance logbook |
Quality Control Logbook
| Sample Registration logbook | Stability Protocol logbook |
| Chemical initiation logbook | Chemical Booking logbook |
| Sample Management Logbook | Standard log |
| Impurity Standard log | Working standard log |
| Reference Standard log | Laboratory standard log |
| Column Usage log | Incubation log |
| Experiment template log | Sample Withdrawal log |
| Pilot experiment log | GC Usage log |
Documentation Logbook
| Document Issuance logbook | Quality observation log logbook |
| Request Issuance, Retrieval log | Extension request for OOC log |
| Training Material Issuance | Batch Detail log |
| Training attendance logbook | Packing Material logbook |
Cleaning and Sanitation Logbook
| Weekly Drain Point sanitation | Accessories cleaning Log logbook |
| In-Process Container Cleaning | Sequential Log |
| Portable equipment log | Daily cleaning or sanitation |
P&G adopts AmpleLogic’s eLogs for real-time operational insights and efficiency improvements – Access the complete case study
Modules
Alarm Management Module
AmpleLogic eLogbook
Industries We Serve
Industry-Specific Software for Enhanced Quality and Compliance
Articles
Harmonizing Voluminous Logbooks eases Record Keeping in the Pharmaceutical Industry
The global pharmaceutical industry has boomed for decades by increasing its market in both the developed and the developing nation. With the evolution of data-
Frequently Asked Questions
What sets AmpleLogic eLogbook apart from traditional logbooks?
AmpleLogic offers a comprehensive digital logbook software solution, replacing manual paperwork with automated processes, ensuring accuracy and compliance.
Is AmpleLogic eLogbook compliant with FDA regulations?
Yes, our eLogbook is fully compliant with FDA regulations, including 21 CFR Part 11, ensuring the highest standards in electronic record-keeping.
How does eLogbook enhance operational efficiency?
By automating tasks, providing real-time visibility, and streamlining workflows, eLogbook significantly reduces manual efforts and enhances overall efficiency.
Can eLogbook be customized to fit our specific needs?
Absolutely. Our eLogbook is designed with flexibility in mind, allowing for customization to meet the unique requirements of different industries and organizations.
How does eLogbook handle data security and integrity?
Security is a top priority. eLogbook employs robust measures to ensure data security and integrity, preventing unauthorized access and maintaining the accuracy of logbook entries.
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Your Pharma Automation Starts Here
We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage:
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Discovery and consultation session
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