Computer Software Assurance by Design

The Right Approach for the Right Solution. How we are different.

Computer Software Assurance (CSA) by Design

Many life science companies have implemented software from different vendors only to realize later that this has created siloes of disparate data. Unless integrated, these siloed systems will limit an organization’s ability to implement newer technologies, such as Artificial Intelligence (AI) or machine learning solutions.

These disparate solutions can now be brought together using digital transformation strategies. This evolving strategy helps organizations with limited IT staff to automate processes and integrate disparate (siloed) systems and data.

Using Agile Software Development Life Cycle (SDLC) methodology, lean six sigma strategies, and an intelligent Business Process Management (iBPM) platform, organizations can automate processes quickly while addressing compliance and validation requirements.

Within the Agile SDLC, sprints are used to produce a working solution. Each sprint typically lasts two to four weeks, or 10 to 20 business days. A sprint follows the same basic outline:

  • Plan;
  • Develop;
  • Test/QA Validation;
  • Deliver;
  • Assess.

Success is defined by citizen developers delivering an automated process in a shorter timeline with a quicker ROI. The result is changing the paradigm of your quality department from the role of reactive enforcer to proactive digital transformation leader.


Azimuth Compliance Consulting can provide your organization the guidance and training you need to ensure quality is built into the design of your automated process while assessing risk based on patient safety, product quality, and data integrity.


Azimuth suggests there are paths you can take to achieve a CSA by design solution.

Your Options: