Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance


By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

If you’re using software in the product development process, it better be validated.

Everyone wants that beautiful smile with a nice set of white choppers that are perfectly aligned. In fact, in a perfect world, having at least 32 reasons to smile (the number of teeth in a healthy adult mouth) is just a fabulous way to greet the world each day. However, for those of us with impacted wisdom teeth, the big smile may turn into a grimace. Regardless, Dr. D is quite sure the FDA was not smiling at the establishment that is the focus of this week’s guidance. Come to think of it, neither was the Chief Jailable Officer (CJO) when this individual received a letter from the FDA directing the establishment to stop shipping their violative product, a dental alignment device. For all of you CJOs that read the doctor’s weekly tirades, please remember, the FDA’s investigator pool is not filled with a bunch of sinecures (look-it-up). These representatives of the agency are tasked with performing a difficult job and want to ensure the public’s health is adequately protected. Smile!

Warning Letter – October 30, 2015

The doctor must admit that it is a rare treat to read about computer software not being validated for its intended use. You see, the device industry received this message from the FDA years ago and as a result, most device establishments go to great lengths to ensure their software is appropriately validated. When software is being used to design, develop, manufacture or accept a finished device (including ERP & MRP systems), it darn-well better be validated. If not, the offending establishment should be prepared for the Form 483 observation when an investigator from the agency magically appears for that cup of coffee and an inspection.

Warning Letter Excerpt

Observation Two: Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i).

a. Your firm uses “(b)(4)” and “(b)(4)” to take (b)(4) of patients’ teeth and determine the desired movement pattern to generate your dental aligners. Your firm has not validated this software, you use as part of your production activities, for its intended use.

b. Your firm uses “(b)(4)” and “(b)(4)” to convert (b)(4) of patients’ impressions to file types compatible with the (b)(4) used to manufacture the molds for your dental aligners. You have not validated these software programs for their intended use.”

“In addition, we remind you, as identified in the Acknowledgement Letter submitted to your firm by FDA on September 16, 2015, you may not place this Crystal Braces dental aligner device into commercial distribution until you receive a letter from FDA allowing you to do so.”

21 CFR, Part 820.70(i) – Production and Process Control

 (i) Automated processes. “When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented.”

Compliance for Dummies

For this week’s guidance, Dr. D is not going to bore you with too many details. In fact, there are just a few minor details associated with the validation of software. First off, if at all possible, have the folks that developed the software perform the validation. Simply stated, if they refuse to validate the software, look elsewhere. Because everything in industry is driven by the almighty dollar, establishments may be asked to pay extra for the validation report. If the report is robust, it just might be worth the extra expense.

Secondly, if an establishment decides to execute the software validation, hopefully, they have a software engineer or access to a competent consultant to assist in the validation activities. The FDA, when reviewing software validations, will expect to see specific items that support claims of compliance with the Quality System Regulation. These items include:

  • A well-written protocol (signed, of course)
  • Evidence of training for the folks executing the protocol
  • The actual test results
  • Written rationale that clearly addresses anomalies (e.g., bugs)
  • Written validation report, including a definitive pass/fail statement and requirements for when validation needs to be repeated (signed)


For this week’s guidance, Dr. D will leave the readers with just one takeaway. If your establishment is using computer software in the design, development, manufacture, and acceptance of finished medical devices (including ERP and MRP systems), it better be validated. If not, be prepared for that From 483 observation. If compliance is lacking, you may want to consider giving the investigator decaffeinated coffee versus the real thing. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.


  1. Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
  2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
  3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
  4. FDA. (October 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. CrystalBraces, LLC. Accessed January 19, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm478989.htm

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International