Laby
By KYLI, SAS
Laby typical implementation process:
Initial Consultation and Project Evaluation: Laby team consults with your organization to understand your lab’s structure, operational needs, and preferred hosting (cloud or on-premises). They communicate directly with your IT manager to plan deployment and ensure alignment with your requirements.
Configuration and Data Integration: Laby configures the software to suit your lab’s processes, activities, and access rights. The team assists with integrating your data, such as users, inventory, stocks, and equipment, to ensure a smooth transition from previous systems.
Personalized Training: Each user receives training tailored to their role and activities, enabling them to quickly become operational and maximize the platform’s benefits.
Go-Live and Initial Monitoring: After configuration and training, your lab goes live with Laby. For the first month, an expert from Laby provides personalized follow-up and support, helping users optimize workflows and resolve any issues that arise.
Laby Customisation process:
Laby can be customized extensively to fit specific business and laboratory needs. The platform is designed to adapt to organizations of any size or specialty, from small startups to large enterprises, and across diverse scientific fields. Laby offers simple configuration options that allow you to tailor workflows, activities, and access rights to match your unique operational processes. Core modules such as the Electronic Laboratory Notebook (ELN), recipes and batch preparation, inventory management, procurement automation, and equipment maintenance can all be adjusted to suit your lab’s specific requirements.
Quality documentation workflows and scientific bibliography management are also customizable, enabling labs to prepare, validate, and distribute quality documents according to their standards. Digital signature features are compliant with 21CFR part 11 and EIDAS, ensuring that documentation meets regulatory and security needs. Timesheet tracking and export functions can be configured to align with your project management and reporting requirements.
Laby offers a suite of training and support resources to ensure new users can effectively adopt and utilize its laboratory management platform. Here's an overview of the available :
In-Person Training: Tailored sessions conducted on-site to address specific team needs.
Live Online Training: Interactive virtual sessions that facilitate real-time learning and engagement.
Webinars: Regularly scheduled webinars covering various aspects of the platform and best practices.
Documentation: Comprehensive user guides and manuals available through the Laby Documentation Center to assist with self-paced learning.
Video Tutorials: A collection of instructional videos demonstrating platform features and workflows.
Technical Support: Dedicated assistance for existing customers to address software usage and associated services.
Personalized Onboarding: Customized support to help new users plan and implement the Laby solution effectively.
Laby implements a suite of security measures to safeguard laboratory data, ensuring compliance with industry standards and protecting sensitive information. Here's an overview of the key security features:
Two-Level Signature Process: Laby employs a dual-signature mechanism to authenticate data. The first signature locks the data, while the second, performed by a different authorized user, finalizes it. This process ensures data integrity and authenticity.
Time-Stamping with Trusted Third Party: Each signature is time-stamped using a trusted third-party service, compliant with RFC 3161 standards, providing a verifiable record of when the data was signed.
Immutable Data Storage: Once signed, data cannot be modified or deleted, preserving its original state for audit and compliance purposes.
Role-Based Access Control (RBAC): Laby allows administrators to assign specific roles and permissions to users, ensuring that individuals can only access data relevant to their responsibilities.
User Authentication: Access to the platform requires user authentication, adding a layer of security to prevent unauthorized access.
Comprehensive Audit Trails: Laby maintains detailed logs of all user activities, including data creation, modification, and access, facilitating transparency and accountability.
Quality Documentation Control: The platform provides tools for managing quality documents, including version control, approval workflows, and access restrictions, ensuring that only authorized personnel can modify critical documents.
Secure Data Hosting: Laby's infrastructure is hosted by OVH SAS, a reputable hosting provider known for its robust security measures and compliance with data protection regulations.
Laby supports the right to data portability, allowing users to:
Access and Transfer Data: Users can request their personal data in a structured, commonly used, and machine-readable format, facilitating easy transfer to another service provider.
Exercise Rights: To initiate a data portability request, users can contact Laby at [email protected].
Laby implements robust security measures to protect user data, including:
Access Controls: Only authorized personnel within specific departments (marketing, communication, customer relations, internal IT, sales) have access to user data, limited to what's necessary for their roles.
Third-Party Subcontractors: Data may be shared with selected subcontractors (e.g., hosting providers, email routers, CRM services) who meet Laby's quality and security standards.
Laby offers a flexible subscription model designed to accommodate the evolving needs of organizations. Here's an overview of how Laby handles scaling:
Feature Access: Laby's subscription includes all features, allowing organizations to utilize additional functionalities as their needs grow without changing plans.
User Expansion: Organizations can add more users to their existing subscription to support team growth.
Data Management: As data volume increases, Laby's infrastructure supports expanded storage and management capabilities.
Flexible Adjustments: Organizations can reduce the number of users or scale back on certain functionalities as needed.
Cost Efficiency: Adjusting the scale of usage can help manage and optimize subscription costs.
No Setup Fees: Laby does not charge setup fees, making it easier for organizations to adjust their usage without incurring additional costs.
Laby developed by KYLI, is a laboratory information management system (LIMS) tailored for research and development laboratories. While the platform does not explicitly list all compliance standards it meets, several features suggest adherence to key industry regulations.
21 CFR Part 11 (FDA): Laby's digital signature functionality aligns with FDA's 21 CFR Part 11, ensuring electronic records are trustworthy and equivalent to paper records.
eIDAS (EU): The platform complies with the EU's eIDAS regulation, which governs electronic identification and trust services.
RCF 3161: Laby utilizes a trusted third party recommended by the EU for electronic signatures, ensuring authenticity and legal validity.
Audit Trails: Laby maintains comprehensive audit trails, recording all actions on documents, which is crucial for regulatory compliance during inspections.
Version Control: The platform supports versioning of documents, ensuring that the most current procedures are followed and that historical versions are accessible for review.
Access Control: Role-based access ensures that only authorized personnel can create, modify, or approve documents, maintaining data integrity.
Data Integrity: Laby emphasizes the collection, saving, tracing, and securing of company data to ensure its integrity, a fundamental aspect of quality management.
Process Standardization: The platform allows laboratories to define and implement standardized processes, aligning with best practices in quality management.
Centralized Information: Laby centralizes strategic data, providing consistent information across teams and supporting innovation.
GMP Compliance: Laby's recipe and batch preparation features are designed to comply with Good Manufacturing Practice (GMP) standards, ensuring controlled production processes.
Product Traceability: The platform offers traceability of products from design to use, facilitating robust quality control and compliance with regulatory requirements.
Automated Tracking: Laby automates the operational management and traceability of products, ensuring compliance with inventory management standards.
