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Operations & Compliance

Total Quality & Compliance for Operations and Logistics Management. A Single Platform for Laboratory Operations & Compliance (O&C).

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Pristima XD Operations & Compliance Overview

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.

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Book a demo with us now to experience a tailored solution that specifically addresses your current business needs.

Reduce Compliance Risk

Implement an all-in-one digital cloud platform to be always ready to meet compliance needs.

Increase Efficiency​

Replace standalone applications and paper trails with fully customized digital solutions.

Reduce Cost by 30%

Compliance Embedded, Quality Engrained, Data Integrity Assured

Features of the Pristima XD Operations & Compliance

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.

Enable Automated Management of Training Records

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).

Compliance-Friendly Document Versioning, Change Control, and Comparison

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 that manage meeting agendas and inspections.

Pristima XD Quality Management Modules

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.

CAPA Management

CQRM® XD Quality Management software makes managing CAPAs easy with a comprehensive CAPA workflow embedded in the enterprise quality management solution.

Audit Management

Within CQRM XD’s Audit Management Module, products and services can be audited to ensure quality adherence throughout the entire value chain.

Change Management

With our Processes-In-Control dashboard, managers can see the status of current processes, identify bottlenecks, and review critical indicators to optimize process performance.

Nonconformances

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.

Document Management

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.

Learning Management

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.

Compliance for Laboratory Research Administration

Under 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 Biosafety (IBC)
  • Conflict of Interest (COI)
  • Material Transfer Agreements (MTA)
  • Invention Disclosure (ID)
  • Copyright Disclosure (CD)

How Pristima XD Operations and Compliance Can Help

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.

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