Introduction

In 1997 the Food and Drug Administration (FDA) issued the final rule on the criteria under which the Agency will accept electronic signatures and records in lieu of handwritten signatures and records executed on paper. The scope of this regulation, US FDA 21 CFR Part 11, is significant and impacts all computer systems related to the manufacturing of a life science product (for example, oral solid dosage, biologic, or medical device). According to the rule, “This Part (21 CFR Part 11) applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted.” Legacy systems, including Microsoft® Access database software and Microsoft Excel spreadsheet software, are not protected by a legacy system clause. The dollar cost of remediating these systems is calculated in the millions. However, the cost of not taking advantage of electronic records and signatures can be detrimental to the competitiveness of a company’s position in its marketplace.

The purpose of this document is to provide life science manufacturers with a description of how a FactoryTalk® Optix application can address the technical requirements of Part 11.  Each manufacturer has a set of unique needs and interpretation of Part 11; Rockwell Automation recognizes the demands of life sciences manufacturers and has created a solution that is flexible enough to address these differences. The objective is to help life sciences manufacturers quickly and cost-effectively comply with 21 CFR Part 11.