- GMP-Monitoring
- GMP electronic Logbook
- GMP visualisation for AVEVA PI
Our electronic logbook replaces handwritten entries with a digital, tamper-proof solution that is fully GMP-compliant. Processes are documented in a more efficient, more traceable way that is ready for audit at all times. The FL-eLogbook can be optimally adapted to the needs of the customer.
Complete and traceable documentation of all manufacturing steps – from start to final approval. Each work step is carefully recorded to ensure compliance with regulatory requirements (e.g. GMP) and maximum process reliability.
Documentation of all maintenance and servicing activities – from planned measures to recurring interventions. Every step is tracked in order to reliably meet regulatory requirements and internal quality standards.
Documentation of material storage locations and associated auxiliary equipment. The seamless recording of all storage information allows for complete traceability.
Uniform documentation process as a result of standardised templates, allowing for consistent and error-free recording. Logbook-wide reporting with flexible filtering options allows for fast, targeted analysis and simple audits.
The logbook allows for intuitive and efficient documentation according to the ALCOA+ principles. All entries are tamper-proof, provided with time and user stamps, and displayed in a clear and structured way. Functions such as recurring events, audited change histories, and validation and release mechanisms support consistent and rule-compliant recording. Powerful analysis and reporting functions allow for targeted evaluation according to criteria such as time period, user or content, whereby all data can be exported flexibly. Role-based access rights and a user-friendly interface ensure transparency, traceability and efficiency throughout the entire documentation process.
All relevant information in a logbook, such as the most recent entries and active processes, is displayed in a clear view that allows for quick and easy orientation.
The system allows for user-friendly and time-saving documentation. Clear input structures, predefined text modules and process-guided workflows simplify recording and improve data quality. Audited corrections ensure transparent traceability of changes, while invalid or incorrect entries can be systematically invalidated and thus excluded from further processing.
The system offers comprehensive analysis and reporting functions that enable detailed evaluation of logbook entries. Users can create individual reports based on specific criteria such as time period, user or content. The reports can be flexibly adapted and exported in different formats (e.g. PDF, Excel).
GMP-compliant recording, visualisation and automation of logbooks
Compliant with FDA 21 CFR Part 11/EU Annex 11 and data integrity
ALCOA+-compliant documentation
Simple and intuitive to use
Complete integration of the solution into the customer’s system landscape
No installation of client tools
Fully compatible with mobile devices such as smartphones and tablets
Template fields
from V1.0
Drop-down list
from V1.0
Witness function
from V1.0
Processes
from V1.0
Reusability
from V1.0
Customisation
from V1.0
Hierarchical tree structure
from V1.0
Direct logbook access
from V1.0
Linking QR codes
from V1.0
Logbook overview in one screen
from V1.0
Tabular presentation of all logbook entries
from V1.0
Display time zone
from V1.0
Multilingual/language switching
optional
from V1.0
Logbook report
from V1.0
Configuration reports
from V1.0
Automatically generated reports
optional
from V1.0
Reviews
optional
from V1.0
Recurring events
optional
from V1.0
Duplicate entries
upcoming
Self-monitoring
from V1.0
Overview of system status
from V1.0
Logbook configuration
from V1.0
Configuration of the navigation tree
from V1.0
Configuration of templates
from V1.0
Confirmation of configuration adjustments
from V1.0
User management
from V1.0
Audit trail
from V1.0
System backup
from V1.0
Active Directory
from V1.0
We can supplement your project with the following services if required:
We support you in the professional planning and conception of your electronic logbook. Together, we develop a structured implementation concept that is tailored to your operational processes and regulatory requirements and complies with ALCOA+.
Standardised CSV design and qualification documents ensure an efficient GMP-compliant CSV process. We would be happy to provide you with our documents.
We offer tailor-made training for your key users – even as part of after-sales support.
We support you with planned and unplanned maintenance. Tailored service level agreements make it easier for you to manage and maintain the systems.
We support you with the initial commissioning of the system and, on request, take over the import of your existing master data. In this way, we create a sound basis for a smooth start with the FL-eLogbook.
