FUNCTION COMPLIANCE SERVICES
Because achieving failsafe compliance is much more than a checklist.
Managing risk & compliance
We design integrated compliance systems that work for complex organizations
Organizations with critical and sensitive materials go to great lengths to ensure compliance in their operations. Healthcare is a great example. They are responsible for patient safety and for the integrity of the life saving products they administer. Most have installed multiple automated environmental monitoring solutions to address these high-risk environments.
We see again and again that when sophisticated equipment is used without a fully integrated program, safety is not guaranteed and compliance is not achieved.
Even the best environmental monitoring solutions become challenged over time
Rapid change inherent in business operations impacts the efficacy of your monitoring solutions. Routine operational changes can cause the best solutions to become difficult to manage, or even worse, become ineffective and dangerous.
Some issues will be more obvious and closely linked to equipment and reports – things like gaps in installations, calibrations, and certifications. More insidious and harder to track are organic changes that occur – events like corporate restructuring, growth surges, and employee turnover. These can have a dramatic impact on compliance workflow.
We work with your team to investigate pain points, understand interactions, and identify gaps.
We design sustainable workflows that empower stakeholders to confidently take the corrective action needed to protect product integrity and patient safety.
We restructure your system and implement enhanced workflows to ensure accurate and timely communication of reliable data to engaged stakeholders.
We routinely address hardware coverage and calibration gaps, and realign system configuration to support changes in personnel, regulations, and clinical operations.
Working With Equipment Manufacturers
We help manufacturers create and support fully integrated compliance plans
We work directly with equipment companies and their customers to ensure their compliance plan fully considers the complexities of the organization.
We are often the front line with the customer, allowing manufacturers to focus on innovating their products.
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We would love to talk to you about the peace of mind a true compliance plan will bring to your organization.