21 CFR Part 11 On Electronic Records


When we described the scope and exclusions, permit’s described used approaches, 21 CFR Electronic 820 cGMP, and references to the corresponding tactics.

The very best way to begin this is to convert 21 CFR Electronic 820 cGMP and ISO 13485 requirements from a hard and fast of requirements into your company’s commitments to fulfilling the one’s necessities. For instance: If phase 820. Five, first-rate device, calls for that:

“each producer shall set up and keep a nice Electronic gadget that is appropriate for the specific medical device(s) designed or synthetic, and that meets the requirements of this part.” our manual will country:

21 CFR Electronic 820 QSR.

“QW clinical, LLC. Has hooked up and keeps a nice control gadget that is suitable for the particular Electronic medical device(s) designed and manufactured, and that meets the requirements of 21 CFR Electronic 820 QSR.”

Following this technique by addressing all applicable sections of the QSR and the ISO 13485 standard and referencing helping methods,

we are able to set up a manual that can be used to satisfy the requirements of 21 CFR  Electronic 820 and ISO 13485.

Electronic Strategies

The interplay among the Electronic e-strategies can be documented in some of the approaches. Some agencies select to define the interplay of the top-level methods by means of the usage of versions of parent 1 inside the ISO 9001 2008 standard.

Combining the sort of diagram with references to strategies within the manual will, to a selected degree, outline interactions between your methods.

The final requirement of the detail four.2.2 of ISO 13485 is to outline the shape of the documentation. Very regularly businesses define their systems as 4- or five-level documentation systems in the document management section of the manual.


Any other critical feature of a nice manual, very regularly not noted, is to be a advertising tool. Nicely written and professionally published, a pleasant guide may additionally come to be a effective promotional device.

It could talk to your capability clients, providers, and subcontractors that your company is not only a best-conscious organization, but, that it also knows how to record and talk about its commitment to high quality and compliance with regulatory necessities.

I continually marvel what organizations attain by means of stamping their quality manuals in formidable red capital letters “personal”.

As a long way as I am worried, a quality manual is a corporation’s resume for the best, and if you conceal your resume, there may be an excellent threat that you’ll in no way get an activity! All first-rate Works clients are encouraged to make their high-quality manuals public!

Naming Your documents

As you may have observed, the titles of the files above are pretty brief. It’s miles a very common convention inside the scientific tool manufacturing and different regulated industries to call the second-stage documentation “standard working methods”, called SOPs.

Unless one has a degree known as “Non-trendy operating approaches,” I definitely do no longer see a practical or reasonably priced cause for long titles. As long as a quick identify conveys the concept and leads a person to the right area in the system, allow’s use it.

Quality Works relentlessly promotes this optimization and reduction of waste technique during all our publications and consulting paintings. Allow’s no longer make matters extra complicated than they want to be.

As an example, one of all our clients titled their exceptional manual an “exceptional control gadget satisfactory manual.” I guess, simply “excellent manual” will suggest the same for customers.

Numbering Your files

It is not a specific requirement of 21 CFR Electronic 820 QSR or another law or standard to uniquely range a part or a document. It’s miles an international practice in most documentation systems to provide a file or an aspect a variety of and a name and to pick out its revision stage.

As lengthy documentation titles that we discussed in advance, the use of document numbering formats very often gift opportunities for improvement.

Once I labored with a cGMP-compliant commercial enterprise of less than a hundred humans,21 CFR Electronic manufacturing pretty simple surgical devices.

Their documentation device included some numeration formats relying on the form of a document. One of the procedures had a variety of 000023-001, which they have virtually known as “twenty 3.” Drawings were numbered in a layout like 987-323-11-02.

Is it acceptable to have long and hard to study and don’t forget) report numbers? Yes, of the route! Is it realistic? I do no longer believe so! In the instance above, the process number, without the tab, contains six digits.

This meant that the system turned organized to deal with almost one million documents or part numbers. The organization had about a hundred and fifty files and about the identical wide variety of components and likely would never move past doubling those numbers.

If nothing else, simply analyzing those numbers with sequential zeros in the front may additionally give one a headache. Pretty, this isn’t the worst case.

The enterprise that won our “The Worst element number” Grand Prize assigned twelve (!) characters to their part numbers inside the alphanumeric format.

If you are designing or manufacturing a complicated X-ray, CAT scan or different complex piece of gadget, you will want hundreds or even thousands and thousands of components and documents. In this case, an extended element variety format would be wanted and could make a business experience.

Otherwise, keep yourself the hassle of writing all the ones and zeros and make your numbering gadget practical. One in every of my customers, who won my “The quality part range” Grand Prize, numbered their QMS files as one hundred and one, 102, 103, and so forth. Short and candy! Maximum small- and medium-size corporations will gain from this optimization method.

After all, isn’t always the element identify the best designator? During my entire expert profession, I labored best with a couple of corporations that did not use document numbers. Their documents have been genuinely diagnosed through precise titles and a two-digit revision level, like a satisfactory manual.



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