Computer Software Assurance (CSA)

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

Azimuth Compliance Consulting has followed a risk-based approach to computer system validation prior to the issuance of FDA’s 2004 guidance document on a risk-based approach to pharmaceutical CGMPs and to 2003 guidance document on electronic signatures and electronic records.

With the release of the new Computer Software Assurance guidance document in 2020, we are well positioned to assist our customers in navigating the regulatory process for software assurance including:

Building a computer software assurance policy addressing a risk-based approach to validation of computer software to ensure patient safety and product quality;
Providing guidance and training on writing test scripts that ensure the quality of the software that is being implemented or upgraded does not take months to validate;
Assisting, managing, or leading the qualification process of your software;
Providing templates for:

User requirements;
Risk Assessment;
Configuration Specifications;
Operational / Performance Qualifications;
Trace Matrix;
Protocols.

Azimuth Compliance Consulting can show you ways to reduce your validation effort while assessing risk based on patient safety, product quality, and data integrity. First, you should decide which path to follow.

Your Options:

I am looking to purchase a single end-to-end validation solution that provides consistency, control, and transparency across my organization

I need help with my computer software assurance projects and am searching for an organization that understands my concerns and regulatory needs