With the passage of the final FDA guidance, it is clear that the FDA has narrowed down the focus of this important regulation. The current thinking within the FDA gives the industry much more latitude in defining their Part 11 strategies. It is up to the pharmaceutical companies to redefine their strategy and formulate a cohesive and consistent approach to Part 11 which aligns with their business goals.

What does this all mean?

Part 11 is surely not dead. The impacted companies have two very broad choices:

Stick with paper, fulfill all predicate rules and pretty much forget Part 11

OR

Use e-recs and e-sigs to enhance productivity and apply Part 11/predicate rules
    to comply as well as protect information assets.

After selecting one of these two options, an organization has to formulate a new strategy consistent with their vision going forward. It is clear from the FDA’s “GMPs for the 21st Century Initiative” that they want the industry to adopt new technologies to constantly innovate and not let regulations hamper their advancement. The Part 11 Final Guidance does carry this spirit and becoming Part 11 compliant need not be burdensome. Any company impacted by Part 11 has to go back to predicate rules, apply risk management techniques and refine their Part 11 strategy.