Services

Validation

InfoStrength is auditable to a “no software is released until it is truly validation ready” policy. InfoStrength’s unique best in class software quality program complies with ISO 9001 and its software lifecycle development meets Carnegie Melon Software Engineering Institute’s Capability Maturity Model Level 3 requirements. InfoStrength’s audited software development methodology enables us to provide a validation ready solution that is unmatched in the industry:

Software Development Process Comparison

Development Stage InfoStrength Competitors
User Requirement Specification check check
Functional Design Specification check check
Exhaustive Traceability Matrix check not checked
Exhaustive Operational / Performance Qualification check not checked
Full Execution of OQ / PQ Prior to Software Release check not checked
All OQ/ PQ Must Pass Prior to Software Release check not checked
Auditable to the Above Process check not checked

The result of following this process is a much higher quality product that is truly validation ready. We can deliver the qualification package directly to the client saving many months of labor and costs in lieu of creating their own qualification package. Validation strategies for our ASP Model clients have occurred in less than 2 weeks.

Moreover, InfoStrength’s software development practices avoid the costly need for software patches that is a common practice of competitive solutions which results in the need to expand the customer’s validation costs and risk the validation state of applications.