Maintain regulatory compliance through robust asset management, maintenance, and reliability programs. Our specialized solutions ensure your life sciences organization meets strict regulatory requirements while optimizing operational efficiency and minimizing compliance risks.
Poor asset management in regulated industries leads to significant financial and operational consequences beyond obvious fines and penalties.
Governing bodies enforces strict guidelines to ensure manufacturing processes produce safe, effective, and high-quality products. Compliance is essential for operational success.
Equipment must be appropriately designed, calibrated, maintained, and operated to ensure consistent product quality and safety throughout the manufacturing process.
Companies must demonstrate equipment and processes meet their intended purposes through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Maintenance activities including preventive (PM), corrective (CM), and predictive (PdM) must be documented to create an auditable trail for regulatory compliance.
Maintenance, calibration, and asset performance data must adhere to ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
Our comprehensive approach ensures compliance while optimizing asset performance and operational efficiency throughout the entire asset lifecycle.
Properly classify critical assets to prioritize maintenance and allocate resources efficiently based on risk and regulatory impact.
Manage assets from commissioning to decommissioning, ensuring compliance and optimized performance throughout their lifecycle.
Utilize risk assessments like Failure Modes and Effects Analysis (FMEA) to focus on high-risk areas and prevent critical failures.
Establish calibration intervals based on Critical Process Parameters (CPPs) and tolerances to ensure instruments remain within required specifications.
Implement proven strategies that ensure regulatory compliance while maximizing equipment reliability and operational efficiency.
Develop PM schedules using OEM guidelines and real-world data. Continuously monitor and analyze maintenance trends to optimize processes.
Monitor equipment in real-time using data such as temperature, pressure, and vibration to perform maintenance only when needed.
Use advanced technologies like thermography and vibration analysis to predict failures, minimizing unplanned downtime.
Transition from manual processes to advanced cloud-based CMMS solutions to ensure data integrity and gain actionable insights.
Train maintenance teams in GMP compliance and best practices to reduce human error and improve operational efficiency.
Deploy mobile applications for real-time data entry, paperless workflows, and field-based calibration and maintenance tasks.
To meet Regulatory expectations, organizations should adopt relevant industry standards and guidelines that provide frameworks for compliant operations.
Provides a framework for developing systems that maximize asset value and ensure regulatory compliance.
Outlines principles for equipment specification, design, and verification to ensure quality in pharmaceutical applications.
Integrates risk management into processes to enhance reliability and compliance throughout the product lifecycle.
Offers actionable recommendations for implementing maintenance, calibration, and reliability programs in life sciences.
Risk-based approach to compliant GxP computerized systems for pharmaceutical and biotechnology industries.
Ensures calibration certificates meet international standards for accuracy and traceability requirements.
Navigating regulations and industry standards requires specialized expertise. We bring decades of experience supporting life sciences organizations through comprehensive compliance solutions.
Comprehensive IQ, OQ, and PQ protocol development and execution to ensure equipment meets intended purposes and regulatory requirements.
Systematic evaluation and classification of assets based on regulatory impact, operational criticality, and risk assessment methodologies.
Advanced risk assessment techniques including Failure Modes and Effects Analysis to optimize maintenance strategies and prevent critical failures.
Implementation of advanced cloud-based Computerized Maintenance Management Systems with full 21 CFR Part 11 compliance and data integrity assurance.
Our specialized expertise serves regulated industries where compliance and precision are critical to operational success and patient safety.
Drug manufacturing and development facilities requiring strict regulatory compliance and cGMP adherence.
Biotech companies developing innovative therapies with complex manufacturing processes and regulatory requirements.
Medical device manufacturers requiring ISO 13485 compliance and FDA quality system regulations.
Food processing facilities requiring HACCP compliance and governing food safety regulations.
Chemical plants with complex processes requiring precise control and environmental compliance.
CMOs and CDMOs serving multiple clients with varying regulatory requirements and quality standards.
In the life sciences sector, compliance is more than a regulatory obligation—it's a competitive advantage. A well-designed asset management, maintenance, and reliability program ensures operational excellence, minimizes risks, and enhances compliance.