FDA Warning Letter on CSV/Part 11

The author has always argued that CSV and Part 11 in computer systems I have argued that we should not be overly accommodating with regard to
One consultant explains, “All computer systems that are shown to inspectors at FDA inspections must be CSV/Part 11 compliant. One consultant explained, “All computer systems to be shown to inspectors at FDA inspections, etc. must be CSV/Part 11 compliant.
Examples include a document management system to explain the QMS, a complaint management system, and a CAPA system.
In the author’s experience, there have been no cases where CSV has been pointed out simply because CSV has not been implemented for document management systems, complaint management systems, CAPA systems, etc.
The same is true of past FDA Warning Letters.
In the past, incomplete CSV triggered the issuance of a Warning Letter There are no cases.
In many cases, warning letters are issued due to other important factors (e.g., CAPA, grievances), which pull them in and mention CSVs.
In most cases, a Warning Letter is issued because the contents of the Response Letter are inappropriate (e.g., not understanding the inspector’s remarks at all) in response to the inspector’s remarks on FDA Form 483.

The author is not saying that CSV/Part 11 compliance is unnecessary. I am arguing that excessive compliance is unnecessary.
This is because overreaction unnecessarily drives up compliance costs.
CSV/Part 11 compliance is, so to speak, an offshoot of quality control/quality assurance. More resources should be spent on quality control/quality assurance for the original product.

CSV Warning Letter

CSV citations for medical device companies are issued as 820.70(i) Automated processes violations.
The point is that there is a fixed sentence that reads, “Failure to adequately validate computer software used as part of production for its intended use in accordance with an established protocol, as required by 21 CFR 820.70(i). Failure to adequately validate computer software used as part of production for its intended use according to an established protocol, as required by 21 CFR 820.70(i). ” (Failure to adequately validate computer software used as part of production for its intended use in accordance with an established protocol, as required by 21 CFR 820.70(i). ().
The key here is “intended use“.
In many cases, computer systems are used to explain manufacturing records, complaint information, CAPA controls, etc. to inspectors during inspections.
At that time, if the rules and procedures described in the QMS (SOP) differ from the processing procedures and functions of the computer system, the above point may be raised.
Most of the software pointed out is software produced by the company itself. (Rarely is a point raised for commercially available software.)
For example, the following examples are given

• When complaint information is approved in the complaint management system, the data is locked and cannot be modified, but the SOP is to update the information as appropriate based on follow-up information.
• In the production record, the person in charge can freely change the pass/fail status of the inspection. No warning is displayed when doing so.

In other words, it is clearly a case of inappropriate software function.
It is rare to find a case where a CSV is pointed out simply because it was not implemented, and it has been developed into a warning letter.

Warning Letter on Part 11

No Part 11 remarks or Warning Letters have been issued in the last 20 years.
While there are some references in the Warning Letter to electronic records and electronic signatures, most of the remarks are about inadequate document and record management.
In other words, they happen to create/store records electronically, but the management of those records is not in accordance with the rules and procedures set forth in the regulatory requirements and QMS (SOP).
It also uses electronic signatures, but the signatures are not signed in accordance with the rules and procedures set forth in the QMS (SOP).

About Blind Compliance

Many medical device companies are eager to avoid the findings of inspections. They also try to comply with regulatory requirements in the dark. This is the so-called blind compliance situation.
However. The original purpose or goal is not to pass inspections. It is to assure the quality of the product, patient safety, and product efficacy.
FDA inspections will raise essential points. Points will not be raised simply because CSV has not been implemented or because Part 11 compliance has not been achieved.
As noted above, a computer system function is indicated when it is determined to be in violation of SOPs, clearly fraudulent, or at risk.
The non-essential point is that it forces companies to spend extra compliance costs expenditures, which in turn are passed on to product prices, driving up patient costs.

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