Enabling Insurance Enterprise Efficiency
September 30, 2024
The ever-evolving world of Pharma 4.0 demands integrated solutions to streamline the complexities of Computerized System Validation compliance.
Validation is essential for regulatory compliance as outlined in FDA 21 CFR 11 and EMA Annex 11, PICS. This process ensures that both new and existing computer systems consistently achieve their intended purposes by meeting predetermined specifications and quality standards.
At Smart IMS, we adopt a pro-active risk-based approach to computer system validation (CSV) and Computer Software Assurance, creating bespoke solutions tailored to your needs. Our specialists have extensive experience in validating both COTS (Commercially Off-The-Shelf) applications and custom-developed platforms in accordance with GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 regulatory requirements.
Client Speak
Thank you, Smart IMS for the Exceptional Computer Systems Validation training! This program has enhanced our team’s knowledge and skill, equipping us with the tools needed to improve our processes.
Quality Manager
Interchemie Werken De Adelaar Eesti AS
Our Offerings
Smart IMS Life Science’s global reach and diverse capabilities enable us to offer innovative and cost-effective solutions, including and not limited to:
Laboratory Equipment Systems Validation
Comprehensive Laboratory Equipment System Validation services comprising of qualification of instruments, method validation, and maintenance to guarantee data accuracy and reliability.
Quality Management Systems
Custom tailored GxP Quality Management Systems (QMS) focused towards enhancing operational efficiency through document control, audit management, corrective and preventive actions (CAPA).
Facility Automation Management Systems
Optimize building operations, enhance energy efficiency, and ensure regulatory compliance, to ensure improved operational performance and cost savings.
Manufacturing Execution Systems (MES)
Unlock real-time monitoring, data collection, and analysis to drive operational excellence through Smart IMS Manufacturing Execution Systems.
Plant Maintenance Asset Management Systems
Ensure cost-effective plant operations through a comprehensive Plant Maintenance Asset Management System comprising of predictive maintenance, work order management, and asset tracking.
Automation Testing of Systems
Comprehensive automation testing services for CSV, aimed towards enhancing efficiency, accuracy, and compliance in your automated validation processes.
Electronic Document Management Systems Validation (EDMS)
Our service covers system configuration, data migration, and validation protocols to ensure the integrity and compliance of Electronic Document Management.
Implementation & Validation
Specialized implementation and validation of critical computerized systems across various industries of life sciences that meet regulatory requirements and provide reliable solutions.
GxP Validated Clinical Data Cloud Systems
Advanced GxP Pre validated Clinical Data Systems and regulatory complaint systems, that streamline data collection, management, and analysis for end-to-end clinical trials.
Data Integrity
Our service includes data governance, validation, and compliance solutions to ensure that data is accurate, complete, and reliable throughout its ALCOA+ lifecycle.
Software Implementation & Validation
Our approach ensures that comprehensive software solutions are validated and deployed efficiently, meet all regulatory requirements, and deliver the expected performance and reliability.
Mock Audit & QA Consulting Services
Identify compliance gaps, process optimization and prepare for regulatory inspections and compliance audits with the CSV Mock Audit and QA Consulting Services.
Additional Offerings:
Commercial Operations (cGMP) Compliance
Maintain compliance with cGMP regulations through robust CSV practices.
Quality Risk Management (QRM) Process Digitalization
Digitize your QRM processes for improved efficiency and risk mitigation.
Digital Continued Process Verification (dCPV)
Leverage digital tools to ensure ongoing process verification is efficient and effective.
Process Analytical Technology (PAT) Implementation
Integrate PAT tools into your processes for real-time quality monitoring.
Post-Approval Change Management
Manage post-approval changes effectively while maintaining data integrity.
Retrospective Quality Reviews
Learn from past experiences and identify areas for improvement through retrospective quality reviews.
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Find some of our latest customer success stories, company updates and wins, and our thoughts on the latest industry developments right here.
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