At IDBS, we leverage over 30 years of experience working with life sciences customers operating under GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice) regulations. We understand the regulatory requirements and challenges customers face in achieving, maintaining and demonstrating compliance.
Comprehensive GxP Solutions
Ensuring compliance and data integrity
The IDBS GxP Cloud platform is designed with the necessary technical controls to ensure data integrity and comply with the applicable computerized systems regulations, such as FDA 21 CFR Part 11 and EudraLex Vol. 4, Annex 11.
Our automated IQ/OQ processes and qualification services reduce the overall validation burden by ensuring correct installation and operation, enabling customers to focus on verifying their specific configuration and intended use.
For assistance with configuration and performance qualification (PQ), our Global Professional Services team offers guidance on best practices and helps deliver required validation artefacts.
The IDBS GxP Cloud is managed by IDBS experts who possess detailed knowledge and training to manage a validated system. This includes infrastructure configuration, installation, upgrade and resource management, ensuring maximum performance and availability while maintaining the system in a validated state.
Explore the GxP resource hub
Data integrity and quality commitment
IDBS incorporates the industry-recognized principles of ALCOA++ into the software and services delivered to customers. We commit to ensuring data integrity, confidentiality and security in all our offerings.
Our Quality Policy highlights our dedication to quality and protecting the integrity of your data.
Serving regulated customers, our implementation and qualification processes leverage automated procedures and version-controlled scripts to ensure a robust, repeatable and accurate deployment and change management of customer environments.
IDBS’ Professional Services team provides technical expertise to help customers define and deliver implementations structured to achieve maximum efficiency.
Our consultants gather requirements, assess operational gaps, recommend process efficiencies to design, configure and deliver solutions that meet business requirements and enhance productivity.
Explore further with these dedicated GxP resources
This whitepaper explores how IDBS empowers BioPharma organizations to achieve and maintain GxP compliance through its advanced cloud-based software solutions, supporting data integrity, security, and quality across the entire drug development lifecycle.
This whitepaper provides a technical overview of the IDBS GxP Cloud, detailing its architecture, deployment and managed services to deliver a secure, scalable, and compliant SaaS environment for regulated operations.
Get in touch to discuss your compliance needs.
