PATCH Solutions, LLC

Why Choose PATCH?

PATCH brings a different perspective to program/project management which helps to drive the success of your projects. Throughout program/project implementation:

  • PATCH asks: “Do the project objectives still support the business goals?” 
  • Other program/project management ask: ”Is [it] on schedule?” or “Is the [it] still within budget?”

Consideration to the impact the program/project objectives have to a life-sciences organization – and subsequently their patients – drives the overall program/project planning by defining scope, key stakeholders, team members, and overall schedule. 

  • PATCH is dedicated to performing proper detail preparation before the program/project is implemented.
  • At PATCH, we understand it is impossible to start implementation without understanding the challenges to success that may arise during program/project execution.
  • By his allows the project team to focus all real-time reactive efforts [to unidentified challenges] when they occur.
  • We mitigate this by addressing all known challenges well before occurrence

Front End Project Set-up:

With PATCH Solutions, the goal is to help you deliver on your Program/Project objectives as quickly & cost-effectively as possible. This starts with proper detailed planning. Understanding the “how to” of Program and Project Management is only part of the solution at PATCH. 

The lessons learned as a leader in planning & executing time-sensitive combat missions within the military – where soldier lives are on the line – translates well to leadership within bio-pharmaceutical & life sciences – where family member and friend lives may be impacted. 

  • Typical Project Planning involves
    • Project initiation and kickoff:
      • Project objective statement
      • Detailed Project Scope Development
      • Project team(s) coordination plan
    • Detailed Project Budget and Financial Analysis
      • Construction Scope of work development
      • Order of magnitude construction cost estimation
      • Construction and equipment bid package assembly
      • Construction and equipment bid comparison (tabulation)
    • Process Flow Development
      • Block flow diagrams and inputs/outputs
    • Facilitation of & Guidance for
    • Process Risk Assessment:
      • Failure Mode Event Analysis
    • System Impact Assessments:
      • “Direct Impact” vs. “Not Direct Impact” systems
    • Commissioning and Qualification Plan Development:
      • For Consumer, Food, and Bio-Pharmaceuticals:
        • per FDA 2011 “Process Validation” guidance to industry
        • the commonly applied 1987 “Process Validation” guidance to industry is outdated and expensive.
      • For Devices:
        • per ISO 13485 “Medical Devices”

Preferred Partners: