QA Edge provides Computer Validation services to FDA-regulated firms. We offer
both long- and short-term assignments for our Computer Validation experts. We
provide training for those who want to learn more about Computer Validation
and we support firms that do not have the internal expertise and/or resources
to complete Computer Validation projects.

Click here to download a brochure featuring our services and experience

 Our services include:

1

Staffing Expertise:
Fees are determined by skills required and length of contract. Click here for a complete listing of QA Edge consultant types.
 

2

Auditing Solutions:
Executing “friendly” audits easily identifies areas of risk regarding your procedures, documentation, controls and systems. Obtaining third-party audits also assures your suppliers have approved standards in place. To learn more about our “common sense” approach, click here.
 

3

Fit for Purpose™ Process:
Provides a thorough, documented assessment supplying evidence that your computer systems are accurate, reliable and fit for use as well as a detailed plan to get your company on the right track should there be deficiencies. The process offers more than a checklist-based assessment but less than a full SLC validation. Click here to learn more.
 

4

SAP Change Control Validation:
Offers an improvement in SAP change control programs which will decrease the cost of each SAP change, improve the probability of success for each change, and shorten the duration needed for each change. To learn more, click here.
 

5

Client On-site Training:
1-Day Risk-Based Approach to Computer Validation
3-Day Risk-Based Approach to Computer Validation
1-Day Auditing Software Suppliers
Overview of Computer Validation Services
 

6

Products for Do-It-Yourself Computer Validation:
Industry Books
Best Practices – FDA Inspections
Best Practices – Macro and Spreadsheet Quality
Best Practices – Network Quality Package

Computer Compliance Made Easy