In today’s global R&D environment, regulatory compliance and laboratory operations are intimately connected. Yet, many traditional laboratory operation solutions, such as LIMS and ELN platforms, have limited capabilities to support the promotion of compliance with regulatory mandates as well as operational excellence.
In addition to supporting the operational aspects of R&D, such as equipment management, training records, material flows, and deviation tracking, the Pristima XD Operations & Compliance module offers additional functions to support laboratory governance, risk, and compliance.
Xybion enables organizations to drive operational efficiency while also maintaining oversight, proper governance, and overall compliance in regulated laboratories operating under GLP, GMP, and GCP.
Allow multiple users to access or review protocol data, attach documents, and cross-reference protocols at the same time. Information security is ensured through user-based access controls.
Easily configure workflows and edit contextual help texts to support researchers and committee members throughout the research process.
Set up email notifications that fire based on time triggers or events. Enable information to flow between authors and committee members and digitally track for compliance.
Leverage a single repository for training, skills, and competencies, and maintain detailed training records. The software includes automatic expiration notices, built-in workflows for training requests, and integration capabilities (e.g., CITI, AALAS learning library, and other customer solutions).
Ensured data integrity with functionality to support document check-in/check-out, automatic versioning, and tracking functionality.
Easily access and download records for committees that manage meeting agendas and inspections.
Pristima XD O&C encompasses embedded quality management across your studies. The secure, cloud-based quality management system enables you to rapidly deploy the solution across every lab globally.
Under global review processes of animal research management, Pristima XD Operations Compliance supports lab assistants in enabling compliance with customizable digital workflows.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.