From: Stat-Ease, Inc.
To: Whom it may concern
Re: Statement on FDA 21 CFR Part 11 compliance
The FDA Title 21 Code of Federal Regulations, Part 11, ruling relates to the use of electronic records and electronic signatures in pharmaceutical manufacturing in accordance with Good Manufacturing Practices (GMP). Our software products, Design-Ease® and Design-Expert®, help scientists design experiments for purposes of product and process development, primarily in an industrial research setting. They do not capture or retain GMP data on durable media. Furthermore, they do not support electronic signatures or incorporate actions intended to replace a hand-written signature. Therefore, the FDA's 21 CFR Part 11 ruling does not apply to Design-Ease or Design-Expert software
Shari Kraber, Principal
If you would like a signed copy of this statement on company letterhead, please contact our office at 1.612.378.9449 or firstname.lastname@example.org.