Pristima Operations & Compliance

Pristima Operations & Compliance offers a comprehensive solution for laboratory operations and compliance in today's global R&D landscape. Many traditional platforms like LIMS and ELN lack capabilities to effectively support regulatory compliance alongside operational excellence. This solution integrates operations, such as equipment management, training, material flows, and deviation tracking, with governance, risk, and compliance functions.

This cloud-based platform is designed to minimize compliance risk and increase efficiency by replacing standalone applications and paper-based records with fully customized digital solutions, helping to reduce costs by up to 30%. It ensures compliance is embedded, quality is integral, and data integrity is assured.

Key Features:

• Multiple Stakeholder Accessibility: Enables protocol data access and review by multiple users, with documents attachment and cross-referencing capabilities, safeguarded by user-based access controls.
• Simplified Workflows: Configurable workflows and help texts guide researchers and committee members.
• Review Process Management: Supports email notifications triggered by time or events, allowing the flow of information between authors and committee members, with compliance tracking.
• Automated Training Management: A centralized repository for training records, with automatic expiration alerts and supported by various learning libraries.
• Document Versioning and Control: Manages document check-in/check-out, automatic version management, and data integrity with robust version comparison.

Additional modules include a Nonconformance module for workflow replication and record-keeping, and a Processes-In-Control dashboard for managers to optimize process performance by identifying bottlenecks. The platform also supports compliance with electronic requirements like FDA's 21 CFR Part 11.

For laboratory research administration, it accommodates compliance with global animal research oversight through customizable workflows, supporting units like Institutional Animal Care and Use Committees and Institutional Review Boards.

Overall, Pristima Operations & Compliance converge operations and compliance into one platform, reducing the cost of ownership, simplifying IT architecture, and providing a more solid solution for compliance in regulated labs under GLP, GMP, and GCP standards.