Process Improvement Engagements

Gap Assessment and Automated Systems

Advantu’s Process Improvement expert, Charlie Gragg, has successfully delivered the following client projects.

Gap AssessmentsFDA Approved

  • Nihon Kohden Digital Health Solutions:  Conducted Gap Assessment between their current QMS and ISO 13485:2016.  Participated in 3 Mock Audits and two on-site audits, the last of which resulted in their successful 13485:2016 Certification (no observations or recommendations).  QMS Gap Assessments followed by three Internal Audits and one External Audit with “no findings”. Implementation of new QMS procedures and workflows using Master Control.
  • Modular Medical: GAP Assessment for 510K Amendment submission. (Project ongoing).
  • Hawkins Inc.: QMS Gap Assessment and Remediation. Creation and Implementation of Process Improvement initiative. Intended Use Validation development and QMS Training.
  • OncoSec: QMS Gap Assessment and Audit Remediation. Client utilized findings successfully.
  • IRRAS: QMS Gap Assessment and Remediation in preparation for successful GMED Submittal. Client GMED Submittal was accepted.
  • Oxford Immunotec LTD: QMS GAP Assessment, Prioritized Remediation recommendations, Remediation Execution and Verification Assessment. 510K Amendment Assessment
  • Synthetic Genomics Inc. (SGI):  SDLC Process Improvement services, Performed GAP Assessment of Design Controls and Cyber Security, developed and implemented a Remediation/Improvement Plan for QMS for Manufacturing and Cyber Security. Implemented GMP Procedure and Process Gaps.  
  • Baxter Hospital Products:  Gap Assessment of Design Controls Policy, Procedures, Work Instruction documentation in a corporate wide initiative to harmonize Design Controls and Tools across Research and Development Organization. (see automated solutions developed).
  • Marinette Marine Corporation:  Short term fast paced Gap Assessment of their Quality System to support ISO 9001 for manufacturing and assembly of State-of-the-Art Shipboard Power Generation Units for USCG Response Boat.  Also led Root Cause Analysis and Validation activities of Production and Assembly Processes. MMC applied findings successfully.

Automated Solutions Developed

  • Defense Communications Agency – Nuclear Planning System (Oracle Application)
  • IRS – TaxLink Modernization (Oracle Application)
  • IRS – Automated Underwriter Reporter (Oracle Application)
  • Ft Rucker – Aviation Maintenance (Oracle Application)
  • Baxter Hospital Products – Managed a remote team developing and validating a Continuous Build/Automated Test Framework for New Product Development (NPD) supporting Multi-Site Continuous Build and Automated V&V