Riggs Biopharma is setting up a new sterile facility.

Mark, who is an Engineering Manager needs to create a URS for purified water generation, storage and distribution systems.

Tight Timelines

Due to work pressure and tight project timelines, Mark decides to rush the review of the detailed software requirement specifications.

He did not specify the software specification requirements precisely and passed them directly to the vendor in order to avoid any project delays.

The vendor developed and delivered the system as per the requirements specified by Mark plus with his own standards.

Not a Smooth Ride

Every effort was being made by the team to complete the project on time in order not to accrue any additional cost.

The ride, however, was not so smooth.

Qualification

During qualification / verification phase it was found that the purified water generation, storage and distribution system did not comply with 21 CFR Part 11.

This caused heated discussions between Riggs Biopharma and the vendor.

Ultimately the software design was changed to align with the regulatory requirements of 21 CFR Part 11.

This led to a delay and cost overrun of the project.

The Takeaway

Cutting corners early on in the project and not reviewing requirements in detail will ultimately hurt the project down the line.