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21 CFR Part 11: Electronic Signatures Vital at $220,000 per Pound

In July of 2008, Ironwood Pharmaceuticals signed an agreement with Slingshot to develop and implement a new Material Inventory and Tracking System (MITS).

The purpose of the technology provided by Slingshot (eStock) will be to manage a number of valuable and sensitive compounds throughout Ironwood’s manufacturing process.

A major component of this is to ensure compliance with a regulation known as “Title 21 Code of Federal Regulations Electronic Records; Electronic Signatures” or 21 CFR Part 11 for short. Slingshot has posted a blog entry on the topic of 21 CFR Part 11 compliance, what it means and how to achieve it.

Based in Cambridge MA, Ironwood Pharmaceuticals is an entrepreneurial pharmaceutical company dedicated to the art and (life) science of great drug making. As you can imagine, the business of producing large quantities of valuable pharmaceuticals for public consumption requires quality control at an Olympic standard.

To deliver against their goal of “making a significant difference in patients’ lives”, Ironwood must satisfy a number of regulations maintained by the U.S. Food and Drug Administration (FDA). As mentioned earlier, 21 CFR Part 11 is just such a regulation. The objective of the legislation is to regulate how electronic signatures are applied, audited and made secure throughout the manufacturing process.

While 21 CFR Part 11 does not mandate that companies use electronic signatures, Ironwood has chosen to go down this path to ensure maximum efficiency and auditability in all of their manufacturing processes. They have done this knowing that the FDA keeps a close eye on every manufacturing process where pharmaceuticals fit for human, animal and plant consumption are being produced.

Slingshot is very pleased to be working with Ironwood on this engagement, and is looking forward to helping another client transition their records management into the on-line medium, and to assure their compliance with Title 21 CFR Part 11 legislation.

As mentioned earlier, we also encourage your review of our blog entry covering the topic of 21 CFR Part 11 software system compliance.