Compliance Associates announces that its Process Validation (PV) and Continued Process Verification (CPV) system, Validator will have seamless integration with SampleManager LIMS, SDMS and LES software, a leading Laboratory Information Management platform for over 35 years. This integration ensures that mutual clients will benefit from a standardized interface between the two platforms.
Organizations that rely on SampleManager LIMS software to manage their quality processes can also access comprehensive PV and CPV functionality with Validator. Validator offers a truly automated process validation platform with predefined and configurable risk assessment, documentation, knowledge management and continued process verification strategies to augment companies’ process validation program.
The integration also ensures that mutual clients benefit from a standardized interface between the two platforms which will provide rapid implementation path, reduce costs, reduce the risk of data integrity issues, and ultimately increase process and product quality.
“A certified interface between SampleManager LIMS software and Validator creates the best of both worlds for our clients as they continue to enjoy the benefits of their LIMS and are provided the opportunity to implement/automate or further enhance their Process Validation program to meet the new and developing regulatory process validation guidelines,” said Victor Zurita, President and CEO of Compliance Associates.
Thermo Scientific SampleManager LIMS software
Thermo Scientific™ SampleManager LIMS™ software delivers laboratory management, data management, (SDMS) and process execution/procedural ELN (LES) capabilities in a single solution. Laboratories across all industries, including pharmaceutical, food and beverage, oil and gas, petrochemical, water and environmental, manufacturing and contract testing rely on SampleManager LIMS software to unlock the power of their laboratory data.
From smaller individual lab deployments through to global multi-site implementations, SampleManager LIMS software delivers all of your needs in one application:
Manage samples, resources, instruments, equipment, stocks, and suppliers
Demonstrate compliance to ISO 17025, GLP and other regulatory requirements
Streamline processes—ensure efficient operation to maximize profits
Manage SOPs electronically and ensure analysts follow SOPs for all aspects of process execution
Preserve quality and data integrity from sample receipt through to report delivery
Improve traceability and chain of custody using barcoding for samples and locations throughout the lab
Drive compliance through secure, future-proofed, central data archival, retrieval, and visualization
Integrate SampleManager with instruments and equipment, CDS, ERP, PIMS, and MES to connect all your valuable data and enable fast, informed decisions
Enable mobile access with SampleManager LIMS software delivered to your tablet
Connect with Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS) software to manage the entire chromatography workflow in one integrated solution
Validator
Validator is a compliant Validation Information Management System that provides organizations with comprehensive solutions for managing the complete Validation lifecycle of all enterprise projects. Validator provides a proven and fully automated methodology of qualifying and documenting computer systems, equipment, and production processes to meet regulatory scrutiny. Current available modules include Computer System Validation (CSV), Process Validation and Continued Process Verification (PV, CPV), Packaging Qualification, Equipment Qualification (EQ). Cleaning Validation – in process. Validator users benefits from:
A framework and strategy for all validation project types, and 21 CFR Part 11 compliance,
A walk-through approach for planning, risk management, test case design, development, and test execution dramatically reducing the burden on organization resources,
Comprehensive and flexible workflow for creation, review and approval of all validation deliverables.
Innovative approach to document creation allowing for expedited creation of project deliverables.
Re-use and re-purpose of data elements for creation of ad-hoc deliverables in minutes
A comprehensive method of implementing and administering standardization and quality standards across the enterprise.
Automation of enterprise risk assessment strategies.
Process/product knowledge management.
Process / Product monitoring CPV
Ability to interface with other enterprise systems for seamless data interchange.
40+% gain in efficiency
Validator makes use of existing internationally recognized standards, guidelines, and industry best practices.