CASE STUDY

A digital marketing and technology company selected RCM to assess their validation and compliance methods in relationship to the new FDA Computer Software Assurance (CSA) Guidance.

Data Analytics

OBJECTIVE

A digital marketing and technology company selected RCM to assess their validation and compliance methods in relationship to the new FDA Computer Software Assurance (CSA) Guidance. The goal was to provide a roadmap that would enable a faster time to market while meeting customer and FDA requirements. The client wanted to improve the development, validation, and deployment of their software product. 

Project Objectives:

  • Interview key personnel to understand the client’s business, learn more about operations, development, and services.
  • Identify regulatory gaps and identify new methods and techniques to address these gaps.
  • Develop Training Module – as required training for all employees on  FDA CSA guidance.

 

SOLUTION

  • RCM’s Executive and Principal  Consultants oversaw the project and conducted the interviews.
  • Assessed the current environment and identified key personnel that were either knowledgeable or trained on data protection
  • Assembled a core team comprising the ‘C’ level leadership team, Operations, Professional Services, Product Management, Quality, Sales and Validation.
  • Developed and agreed upon assessment goals and objectives.
  • Educated core team on opportunities to apply CSA guidance in the development and implementation of their product in support of the objectives and goals.
  • Delivered  Assessment Report and Roadmap enabling Client to realize faster time to market while meeting FDA requirements. 

BENEFITS

  • RCM’s consultants met the aggressive schedule to develop an implementable roadmap to meet  compliance, quality, and delivery goals, on time, on budget, and of high quality.
  • Client was able to apply CSA to advance their technical platform and time to market.

Key Project Elements

Understanding Validation and Compliance methods

 Core Team representation  Key Functions  in the  Development of Roadmap

Mandatory  Employee CSA Training

Enhanced go-to-market service offerings