Total Quality & Compliance for Operations and Logistics Management. A Single Platform for Laboratory Operations & Compliance (O&C).
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.
CQRM® XD Quality Management software makes managing CAPAs easy with a comprehensive CAPA workflow embedded in the enterprise quality management solution.
Within CQRM XD’s Audit Management Module, products and services can be audited to ensure quality adherence throughout the entire value chain.
With our Processes-In-Control dashboard, managers can see the status of current processes, identify bottlenecks, and review critical indicators to optimize process performance.
Whether your organization manages defects, deviations, out-of-spec results, or other types of issues, the CQRM XD Nonconformance module can replicate your workflow, recording, record keeping, and reporting needs.
CQRM XD’s Document Management System (DMS) fully supports the way YOU work. Key platform features are highly configurable to support you in holistically managing compliance-related information across an organization’s entire value chain.
The cloud-based software helps you comply with requirements for electronic signature, electronic records, and software validation such as 21 CFR Part 11 from the FDA.
Under global review processes of animal research management, Pristima XD Operations Compliance supports lab assistants in enabling compliance with customizable digital workflows.
With Pristima XD, you can converge operations and compliance on one platform, resulting in a lower cost of ownership, reduced IT complexity, and a more robust solution for today’s laboratory.
Pristima XD Goes Beyond Traditional LIMS/ELN Systems – 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.