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.
- 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.
- RCM’s Executive and Principal Consultants oversee 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 fasster time to market while meeting FDA requirements.
- 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