Operations & Compliance
Total Quality & Compliance for Operations and Logistics Management
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A Single Platform for Laboratory Operations & Compliance (O&C)
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.
With Pristima XD, you can converge operations and compliance on one platform, resulting in 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.
Key Features of Pristima® XD Operations & Compliance Software
Multiple Stakeholder Accessibility
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.
Simplified Workflows with Configurable Content Help Text
Easily configure workflows and edit contextual help texts to support researchers and committee members throughout the research process.
Review Process Tracking and Management
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. 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.
Minutes of Meeting
Records
Easily access and download records for committees who manage meeting agendas and inspections.
Quality Management
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.
Learn more about our quality management modules:
Compliance for Laboratory Research Administration
In accordance with global review processes of animal research management, Pristima XD Operations Compliance supports lab assistants in enabling compliance with customizable digital workflows.
Research administration & compliance units include:
- Institutional Animal Care and Use (IACUC)
- Institutional Review Boards (IRB)
- Institutional Bio Safety (IBC)
- Conflict of Interest (COI)
- Material Transfer Agreements (MTA)
- Invention Disclosure (ID)
- Copyright Disclosure (CD)
Learn More About Pristima XD Operations & Compliance:
Study Management
Master Schedule, Protocols & Reports
Discovery and Development Process
Online Data Capture
Other Pristima XD modules
Pristima XD
Total Preclinical R&D Management System
Pristima XD Veterinary Management
Complete Animal, Veterinary and Facility Management Including IACUC and Census.
Pristima XD Savante™
Data Repository, Query and Automated Preclinical Data Preparation Solution to Support SEND Submission Standards.
