We help develop systems that support your company's quality management, risk management and regulatory compliance efforts.
Your company’s reputation and legacy depend on the quality of your products and services.
Quality by Design (QbD) is critical to operational success; it must be built into your product or service from the beginning and not retrospectively worked in at the end. We serve both regulated and non-regulated companies alike, developing quality systems that help ensure your products and services meet the high-standards of your customers. Quality metric reviews, change management processes, investigations, SOP development and zero defect program development are just a few areas in which we can help your company advance.
Operational Risk Management
True quality efforts are proactive, not reactive. This means your organization must plan for projects, changes and improvements instead of jumping into them head-first. No matter the topic, we can facilitate risk assessments and help your organization identify, evaluate and mitigate risk - heading-off issues before they arise and saving you time and money.
Regulatory Compliance and Remediation
Inspection readiness is critical to many firms. We work with your team to develop an inspection readiness program that fits your operation and your infrastructure. We will work with you to determine who the critical players are, brainstorm what critical topics may be covered during different types of audits / inspections and what logistics best fit your needs. We can work with your staff to help them become inspection ready by holding mock-interviews and tours.
But what happens when the audit / inspection has ended? Response time is critical and the response time is often painful. We will work to develop a response plan that helps your organization respond fully, accurately and in a timely manner.