CFR 21 Part 11 Validated

BSI was validated using FDA guidelines (CFR 21 Part 11) for software development.

IMS uses a variety of the waterfall software development life cycle (SDLC) model. The model is fully described in the BSI SDLC SOP. The BSI Functional Requirements Specification (FRS), System Design Specification (SDS), and testing scripts are available for review.

BSI has successfully undergone compliance audits by current customers.