Medical Device, Pharmaceutical and Biotechnology firms are rapidly adapting new business models.

Ask yourself, does your Life Science firm need to re-evaluate the way they view and execute manufacturing, product development, quality and business performance, regulatory issues, information technologyquality systems, or supplier management? Today’s changes in regulations and the FDA’s new initiatives have made it necessary for many Life Science firms to evaluate and make changes within their medical device manufacturing models.

“Today the industry is adapting new perspectives and new approaches. New innovations, new designs and new technology are a competitive advantage. Data-centric processes that improve efficiency, maturity and visibility are vital for profitability. Strategic initiatives need to adapt to accelerate product development, improve quality, and improve patient outcomes while spending less.”

Gregory Pierce, CEO of EngiLifeSciences.

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Does your firm focus too heavily on cost cutting measures vs. quality outcomes?

Are regulations and compliance viewed as a burden vs. a competitive advantage?

Are the proper controls in place to accurately assess risk?

If your manufacturing, product development, business performance, regulations, ITquality systems, or supplier management are putting you at risk, it’s time to make changes.

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Information Technology is now the foundation for meeting medical device, pharmaceutical, and biotechnology regulatory and compliance demands.

Historically, the Life Science industry has been heavily paper-based with document-centered business processes. Firms are required to adopt a data-centric approach to maintaining critical data rather than the traditional document-centric approach. The future is moving into a complete digital state, which allows for optimization. This is especially necessary when there is an increased need to reduce costs because of new market conditions. EngiLifeSciences has developed proprietary quality system and software compliance solutions.

Does your organization struggle with Quality System Compliance?

Achieve the optimal level of quality by balancing customer expectations & regulations while achieving a competitive edge & increasing shareholder value.
  • Is your firm feeling economic pressures?
  • Is a lack of streamlined processes and technology increasing your risk of non-routine quality events?

Does your organization struggle with Quality and Business Performance?

Drive operational efficiency so that when industry changes occur, there are lower implementation costs and higher efficiency and execution.
  • Do you have strong and efficient business performance?
  • Would you like to increase your competitive position?

Is your CSV process hindering you from deploying technologies?

Eliminate waste and obtain 25-30% savings.
  • Does your current process impact timelines, increase costs and create risks?
  • Are you utilizing paper-based processes?
  • Is your firm slow to adopt technology?
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EngiLifeSciences prepares life science firms for the future. We invite you to preview our case studies here.

Computer System Validation (CSV) Case Study

EngiLifeSciences™ was hired to execute a Global Optimization IT Assessment for the second largest Life Science Company.
We assessed current policies, procedures, and more and worked with 26 teams to identify cost reduction opportunities.
We identified and prioritized the cost savings while maintaining compliance.
ROI: The strategic roadmap we designed saved more than 25% of the overall CSV cost.
The Benefits of An

EngiLifeSciences™ Partnership

We have focused on creating faster leaner compliance within enterprises.

Our vision is to become the global leader in managed regulatory compliance and engineering solutions that enable Life Science manufacturers to bring safe, high-quality innovations to the market quickly and profitably.

Flexibility and alignment with business objectives.

Building robust CSV Processes that Align with compliance.

Infusing innovative technology into the manufacturing process to ensure speed to market and regulatory compliance while balancing cost vs. quality.

EngiLifeScience Accountability

Our Audit Defense Pledge

When a client engages EngiLifeSciences™, they are enlisting the software validation industry experts. Our proven processes provide sufficient, objective evidence to demonstrate regulatory compliance. If the regulatory body challenges any of the software validation evidence compiled by EngiLifeSciences™ during an audit, we stand behind our work and will defend it in support of our client.

We will provide timely, quality response to the regulatory body. All pertinent documentation is readily available and objective evidence is supported. We will explain and support the software validation efforts performed by our team of experts.

As a result, the EngiLifeSciences™ Audit Defense guarantees lower stress, saves time and helps maintain organizational focus while minimizing the financial impact of audit findings.