Lean Compliance: Six Sigma Streamlines the Life Sciences
“It is our contention that life sciences' firms of all specialties can maintain outstanding compliance, quality and customer service. The objective is to take Lean thinking into your regulated environment to improve service, quality and cost performance, in parallel with ensuring and improving compliance performance.
“After all, the delay of a drug to market can cost a pharmaceutical company millions of dollars per day and in a worst-case scenario, can threaten the lives of patients and a company’s existence. Lean compliance can help prevent these types of serious missteps by eliminating waste, maximizing efficiency, and promoting a culture of collective accountability.”
Pat Lucansky, CSSMBB, CLS, CMC
Executive Director, VIP Group
“After all, the delay of a drug to market can cost a pharmaceutical company millions of dollars per day and in a worst-case scenario, can threaten the lives of patients and a company’s existence. Lean compliance can help prevent these types of serious missteps by eliminating waste, maximizing efficiency, and promoting a culture of collective accountability.”
Pat Lucansky, CSSMBB, CLS, CMC
Executive Director, VIP Group
Lean Compliance is the Future of the Life Sciences
A continual increase in governmental oversight and regulation has fundamentally altered the way many industries throughout the life sciences’ field operate. This culture of compliance has placed many companies and organizations under significant pressure to balance corporate interests with:
- Customer Satisfaction
- Profit Margin
- Product Safety
- Internal Resources
- External Accountability
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The Benefits Of Lean Compliance For Your Company
Operating in a highly regulated environment makes efficient compliance essential for financial success and industrial longevity. Therefore, companies that manufacture and provide regulated medications and other products can benefit from implementing a Lean Compliance culture. A Lean Culture can help facilitate:
- Increased innovative capability by speeding up product development and focusing on just-in-time manufacturing processes
- Increased profitability through streamlined departmental and individual communication and workflow
- Optimized internal resource allocation based on customer need, risk, priority, profitability and value
Lean Compliance is FDA Friendly
The objective is to take Lean thinking into your regulated environment to improve service, quality and cost performance, in parallel with ensuring and improving compliance performance. While most life sciences organizations are dedicated to providing quality, altruistic products to enhance and extend the quality of our lives, they generally do so at a great cost to themselves and to consumers.
A common mis-perception is the statement, “that Lean thing won’t work in our industry especially where the FDA is concerned.” It is our contention that life sciences' firms can maintain compliance, quality and customer service while operating in a Lean environment where meeting customer needs (both regulatory and end-user) is the primary goal.
This actually makes Lean Compliance incredibly FDA friendly, because Lean Compliance allows your business to remain agile and responsive while still complying with FDA regulations. By successfully accomplishing this, your Lean Compliance protocols will help increase response time efficiency—while at the same time, help prevent future FDA violations from occurring.
A common mis-perception is the statement, “that Lean thing won’t work in our industry especially where the FDA is concerned.” It is our contention that life sciences' firms can maintain compliance, quality and customer service while operating in a Lean environment where meeting customer needs (both regulatory and end-user) is the primary goal.
This actually makes Lean Compliance incredibly FDA friendly, because Lean Compliance allows your business to remain agile and responsive while still complying with FDA regulations. By successfully accomplishing this, your Lean Compliance protocols will help increase response time efficiency—while at the same time, help prevent future FDA violations from occurring.
Our Lean Compliance Team Supports Your Daily Operations
We understand that implementing a Lean Compliance culture into your company must take place without adversely affecting its ability to remain fully operable. Therefore, our Lean Compliance team will develop and help implement protocols that meet the specific needs of your company, while ensuring that:
- VIPGroup engagements are organized to provide the least disruptions to ongoing operations
- Cash flow and profitability are retained during any engagement
- The timing of the interactions with your personnel is planned and organized with your senior management before any work begins
- Throughout every engagement, our Lean Compliance team provides continual updates to your senior management on the progress made
- We help provide growth for your employees, as well as personal accountability of implemented processes and products
About VIPGroup’s Lean Compliance Programs
Value Innovation Partners Ltd. specializes in Lean Compliance implementation for businesses of all sizes and specificities. Our associates are known throughout the corporate world for their expertise, precision, professionalism and high success rate. We have helped implement and maintain streamlined operations, industrial, manufacturing and customer service-based practices in businesses just like yours. Contact us today to see how your business, your customers, and your bottom line can immediately benefit from our experience.
