SDLC/QMS/GMP Process Improvement

People + Process + Technology = Product

As technology rapidly evolves and the landscape becomes increasingly competitive, it’s more important than ever to have a product delivery advisor on your side.

“Every day we are challenged with finding ways to improve quality of software development while decreasing time-to-market. Specific areas we focused on were automated tools for development and test, increased transparency and traceability, automated regression analysis and repeatable predictable outcomes.’

‘Charlie Gragg and his team assessed our current development and test situation and presented the best path forward for addressing our specific needs. If you have a similar need, Charlie is the right resource to meet your requirements.’

‘I highly recommend him and his team.'”

Gregory Gulden

Vice President, Device Engineering, Hospital Products

Baxter Healthcare

Top Questions

  • Will I be on time?
  • Will I be on budget?
  • Will the application function as designed?
  • Will our device present an intuitive user interface?
  • Will I have happy customers and increased market share?

Whether you’re creating a new application or adding features to an existing product line, we can help you implement Best Practices to solve your toughest product delivery challenges.

Our experience has shown that after collaborative GAP Analysis, the solution(s) yield distinct product delivery enhancements which can be individually implemented – successfully. Our bottom line goals are to help your team shrink time-to-market, reduce costs and improve customer satisfaction with your products.

Client’s Who’ve Benefited

  • Medtronic
  • Baxter Health Care
  • Obalon Therapeutics
  • FMC
  • Zimmer-Biomet
  • Hospira

What We Do

We Help You

Reduce Time to Market Improve Forecast Accuracy
Minimize Rework & Cut Project Costs Increase Profits by Reducing Technical Support Calls
Improve Product Quality & Reliability  Enjoy Software Delivery Improvements – First 90 Days
Increase Team Productivity & Project Velocity Improve Customer Satisfaction with Your Products

How We Do It

Advantu’s Process Improvement Methodology draws upon the highly successful techniques of the Ishikawa Diagram and 5-Why’s to determine cause and effect relationships.

Advantu concentrates on the following major Process Improvement Categories:

  1. People
  2. Measurement
  3. Environment
  4. Methods

The initial identification of possible Targeted Improvements is identified through Advantu and Client collaboration efforts.

  1. Internal and External Audit Findings
  2. Review of Open and Closed CAPAs
  3. Past Lessons Learned
  4. Development, Manufacturing and Quality Team observations

The identified Causes from the above process are then decomposed into likely “Contributors”.

The “5-Whys” technique is then applied to the likely Contributors to identify the most beneficial improvement solutions. Typically these projects start around 3 weeks and will just need 2 hours per day of your team’s time.

The following is an example of Advantu’s “Cafeteria Plan” for Targeted Results Driven Process Improvement.

Cafeteria Plan

Problem Contributor Solution
Missed User Needs

“counter-intuitive user interface”

Ineffective Human Factors Studies

Voice of the Customer Improvement

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Product Quality & Reliability Issues


Poor Risk Management Request White Paper
Performance Bottlenecks

“the never-satisfied customer”

Inadequate Performance Planning Request White Paper
Time to Market Delay

“perpetual replanning”

Ineffective Resource Allocation

Scope Creep

Issue Correction – Induced Errors

Missing/Late Design Control Deliverables

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If you’re experiencing these software development and product delivery issues, then we know you’re under a lot of stress.

Here’s the good news – we’ve been helping teams address and systematically resolve these issues for decades. Free them from putting out fires & working long weekends – and focus on building new products your customers will love.

Reach out today and request a Free Consultation. There’s a really good chance we’ve seen your issues before and we might surprise you with our (easier-than-you-think) solutions.

Ask Judy to schedule a Free Consultation – today!

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