Several factors are converging to make integration from the plant floor to the executive office and beyond an operational requirement.
The about-face is driven partially by the untapped return from such initiatives. But other factors also are at play, not the least of which are the looming enforcement of standards for electronic records and time-stamped signatures in the six-year-old FDA regulation 21 CFR Part 11 and the more demanding requirements for verifiable records included in the Bioterrorism Preparedness and Response Act. Compliance costs for 21 CFR 11 by pharmaceutical companies alone are pegged at $5 billion, double their spending for Y2K compliance.