FDA Validation Documentation with ServiceNow

John Chun,

Room : Ironwood 3

Subject : Governance, Risk, Compliance

Breakout : New to ServiceNow

Validation documentation is an important part of system development lifecycle (SDLC) in FDA-regulated industries. Given the complexity of today's systems, it can be labor intensive, time consuming, error prone, and expensive. ServiceNow, along with the Fruition Requirements Center tool, can be used to greatly simplify the process of collecting, tracking, and documenting user requirements, functional specifications, detailed designs, and traceability matrix. In this session, a case study will be presented that illustrates the challenges faced with the old way of documentation. You'll hear how using ServiceNow helped dramatically reduce the time, effort, and cost of validation documentation for ServiceNow deployment in a pharmaceutical company. This can also be extended to SDLC documentation of any regulated and non-regulated systems.