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Experienced risk assessors
Risk Management
Risk Management Programs
for Product Lifecycle
for Product Lifecycle
Quality risk management programs for product lifecycle are recognized by regulatory bodies as an important component of an effective quality system and provide a proactive means to identify and control potential quality issues during development and manufacturing. They can also improve decision making if a quality problem arises and provide regulators with greater assurance of a company's ability to manage risks. Whether for legacy systems or for new product efforts, our experienced consultants can use the full spectrum of risk management tools to streamline your projects and develop phase appropriate risk management programs for your product lifecycle.
Preventive and Procedural Controls
Do you have protective guard rails in place for your product safety programs? During the product lifecycle as processes evolve and suppliers change, product safety programs sometimes fall behind. We can help drive product safety programs and using risk assessment tools identify risks, and design controls and procedural controls that can reduce the residual risk. We will walk with you every step of the way to implement controls that can result in quality, safety, and process improvements.
RISK MANAGEMENT
Conduct Risk Assessments
Develop Preventive Controls and Procedural Controls
Establish product safety programs
Review Process Safety programs
Develop risk based validation programs
Contamination control strategies
RISK BASED MONITORING PROGRAMS
Clean Rooms: Environmental Monitoring Program
Cleaning Monitoring program
Sterilization monitoring program
Product and process monitoring program
Equipment monitoring program
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