Background A software developer that provides web-based access to educational content to include conference recordings, recorded lectures, webinars, PowerPoint presentations, etc., secured clients in the pharmaceutical industry, and thus, became subject to regulatory scrutiny.
Business Issue Providing training content and training records for the pharmaceutical industry resulted in customer audits to confirm regulatory compliance. An assessment of audit readiness revealed weaknesses in software development and quality practices.
The Objective Due to the lack of the appropriate regulatory skills on staff and the need to find a timely, cost effective solution, a Managed Services scenario was implemented to address compliance gaps and support customer audits.
The Solution Arbour Group deployed resources to remedy assessment gaps and manage the software development control and quality assurance processes. The processes that were initially managed were:
Software Development Life Cycle (SDLC):
- Review requirements, design reviews and acceptance test results
- Perform validation planning and testing
- Determine software release criteria
- Perform regression testing
- Develop a Quality Manual
- Develop supplier Quality Agreements
- Review, approve and audit of Policies, Standard Operating Procedures and Work Instructions
- Establish quality metrics, monitor trends and promote continuous improvement
- Host customer audits and respond to observations