What’s “21 CFR Part 11”?


Name 21 of the Code of Federal Regulations (CFR) is the primary regulatory foundation for the administration of food and pills within the united states of America by way of the food and Drug Administration (FDA), the Drug Enforcement Administration, and the office of national Drug manage coverage.

Part 11 of identifying 21 units as the standard through which the FDA considers digital information and electronic signatures to be trustworthy, dependable, and usually equal to paper records and handwritten signatures on paper.

The “digital information” segment of element 11 sets out control necessities for closed and open electronic report-preserving systems, as well as requirements for establishing a link between signatures and electronic information.

For greater information on this law, including a list of vital techniques and controls, please go to the digital rules Compilation page. FDA also issued steerage related to part eleven in August 2003, which may be found right here .

How does Dropbox assist me with electronic facts compliance under 21 CFR component eleven?

Dropbox employs independent third-party auditors to check our structures and controls against the maximum broadly well-known security requirements and guidelines in the global,21 CFR part 11 applicability assessment including SOC 1 and 2 kind II, ISO/IEC 27001, and ISO/IEC 27018.

Those evaluations are performed at least as soon as a year and are finished with the aid of international fame, excessive-caliber, independent audit, and security company.

Despite the fact that those audits do not cognizance on 21 CFR element 11, their reason and targets are much like component 11, and they help ensure the safety, confidentiality, integrity, availability, and privacy of facts.

While it’s far in the end up to you to make certain compliance along with your regulatory obligations, you may use those reviews to behavior risk evaluation beneath 21 CFR part 11.

To learn greater approximately how Dropbox can help you comply with FDA 21 CFR component eleven, see our white paper.

Which Dropbox audits, reports and certifications can assist me with my compliance efforts?

Dropbox presents customers with various varieties of audit reviews and certifications that display the effectiveness of the controls applied by Dropbox. You can find a list of those reviews and certifications right here.

Our SOC three report and ISO 27001 certification describe what is most relevant to 21 CFR element 11.

For more facts on those controls, please see our SOC 2 audit record, which you may request through our income crew or assist group (if a current Dropbox business consumer).

To analyze more approximately how Dropbox can help you observe FDA 21 CFR part 11, see our white paper.

What about HelloSign and digital signatures?

Presently, Dropbox and HelloSign no longer provide digital signature-related compliance assistance for 21 CFR element 11.

Validating your personal Excel Spreadsheet utility is vital

A key query many professionals face is: why should digital information be verified? The answer is pretty straightforward: digitizing information is unavoidable because agencies everywhere in the world are moving closer to digital facts and phasing paper data out.

This has grown to be a dire want due to the fact it’s far believed that it is high time the arena moved away from paper facts, each from the angle of ecology conservation and velocity. Digitizing paper records serves those two crucial purposes.

Making information electronic isn’t optional

Digital validation is the antidote to manipulation and forgery, which is one of the inherent dangers of going digital. If digital information ought to take the area of paper information and remain as powerful and genuine; it must be tested.

That is why the FDA has made validation of electronic facts within the pharmaceutical, biotech, clinical device, CRO, lifestyles sciences, or associated FDA-regulated agencies obligatory and compliant with its own regulatory segment in this subject matter, 21 CFR component 11.

A Word About 21 CFR Part 11

21 CFR part eleven is a hard and fast of FDA necessities which serves as the same old with which organizations should be compliant. Being compliant with necessities set out in this code demonstrates that the electronic facts used by groups are genuine and are of the identical requirements as paper records.

Excel Sheet Utility Configuration Is Crucial

For this to appear, a key requirement is that an organization’s Excel spreadsheet utility has to be configured. This needs to be achieved to now not only meet FDA necessities but to additionally keep away from 483s. So, because of this, a company that doesn’t meet 21 CFR part 11 stands to stand 483’s.

Major keep of time and sources

One of the key elements of implementing 21 CFR element eleven is the requirement of configuring their Excel utility with the functions required for 21 CFR element eleven compliance.

When validation has executed the usage of suitable and properly-designed validation templates; an enterprise can’t handiest keep away from 483’s; it is able to keep up to 2-thirds of the validation time and fees.

What Does Compliance Entail?

Implementation of guidelines for electronic records wishes know-how of how to use and validate electronic statistics and signatures, that is what 21 CFR component 11 is essentially all approximately.

Taking a chance-primarily based validation method is a practical step, due to the easy reality that it reduces and from time to time even removes risks.

As for the Excel software themselves, the enterprise must have a method by means which to create the following documentation into their Excel software:

  • O A person requires the record
  • O A undertaking Plan report
  • O A useful specs record
  • O A threat analysis/chance evaluation file
  • O A testing Protocol file

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