Use Lyra safely
Lyra system relies on official standards for development of a computerized system designed to meet to GMP/BPF requirements.
Data integrity
Regulation & Compliance
Lyra complies with two approaches: the 21 CFR Part 11 (FDA) standard and the GAMP 5 guide to meet the highest requirements in terms of developing a computerized system that must comply with GMP (Good Manufacturing Practices) requirements.
Requirements
Audit trail
Electronic signature
Automated testing and verification processes
Processus automatisés de test et de vérification
Supplier evaluation
Agreements, contracts, SLAs, and certification of service providers
Technical aspect
Our developers are dedicated to constantly improving Lyra, ensuring optimal performance and maximum efficiency. Their expertise and innovation guarantee a solution that is always at the forefront of our customers' needs.
High performance
Strong authentication
Data confidentiality
Data integrity
Data traceability
control
strict access
Lyra ensures maximum security through strict access control. Each user is thoroughly verified, guaranteeing secure and reliable use of the software to protect your sensitive data and IT systems.
Requirements
Multi-factor authentication (SMS, third-party application)
Single Sign On (single authentication, identity federation)
Protocol and standard in use (OAuth2)
Confidentiality
Lyra guarantees data confidentiality through advanced encryption, the use of secure TLS protocols, and VPN integration. These measures ensure optimal security and robust protection of sensitive information.
High performance
End-to-end encrypted data
TLS protocol
use of a VPN (IPSec protocol)
Data and services hosted in the European Union
ensuring data integrity based on ALCOA+ principles
Lyra System and traceability
Traceability refers to the generation of traces that enable the behavior of applications In production, this trace helps to understand the behavior of users and those of potential hackers, it also optimizes the operation of applications.
Lyra complies with 21 CFR Part 11
Lyra strictly complies with the regulatory requirements of 21 CFR, ensuring compliance with the strict standards of the pharmaceutical and medical device industries, guaranteeing safety, reliability, and integrity in all its applications.
Traceability through electronic signatures
Each piece of data entered into the system is associated with a unique electronic signature. This allows the authenticity and integrity of the information to be verified, ensuring that it has not been altered and that it comes from an identifiable source.
Audit trail
An external database integrates all actions and time-stamped data, providing a detailed and secure record of each operation. This allows activities to be traced to ensure transparency, compliance, and process integrity.
Computer diagnostic support journals
These logs, integrated by Lyra, record every event and action performed, such as login attempts and file access. By analyzing this time-stamped data, Lyra enables you to quickly diagnose and resolve problems, detect anomalies or intrusions, and thus ensure the proper functioning and security of the system.
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