Clarification for 21 CFR Part 11.100 - General Requirements

Pmarszal

Involved In Discussions
#1
I have been reviewing 21 CFR 11 requirements and feel stumped by section 11.100 - General Requirements

(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.

(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual.

(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.

____________________________________________________

I am confused about 11.100 (C) and (1). When is the certification required to be submitted? Upon agency request or during the implementation of electronic signatures?

:thanks:
 
Elsmar Forum Sponsor

mihzago

Trusted Information Resource
#2
At the time of implementation.

The agency will also ask for such a letter (if you don't have one on file) when you set up an account for electronic gateway with the agency, for example eMDR.
 

Pmarszal

Involved In Discussions
#4
We are only internally going to be using electronic signatures in our QMS and not to the agency? Is this document still required to be submitted?
 

mihzago

Trusted Information Resource
#5
Your QMS documentation may still be viewed by the agency, for example, during an inspection. Generally, if your use of electronic signatures falls under the Part 11 then the letter is required.

The point I was trying to make is that the FDA does not actively ask or enforce these letters for internal QMS systems; maybe during an inspection of document control (anyone heard of a company getting dinged for not having a letter?).
FDA will however, as I said earlier, ask for the letter before you set-up an account to transfer data to them.
 

Dobby1979

Involved In Discussions
#6
Hi Guys.

Whilst we are on the subject of electronic signatures, how does everyone implement / meet this clause?

Sec. 11.200 Electronic signature components and controls.
(1) Employ at least two distinct identification components such as an identification code and password.

Do you count logging on to your PC / laptop as one component and then entering a password when signing is a second component? What tools do you use?
 

Pmarszal

Involved In Discussions
#7
Our current software uses a username and password before logging into the QMS. (We are running a closed system)
 

Dobby1979

Involved In Discussions
#8
Thanks for the reply Pmarszal. So you log into your QMS and then just open a document and click sign. Am sure there are more steps but you get my trail of thought! :)

Have you been audited on your electronic signature? I worry that wouldn't be enough and that you should be password prompted etc. at time of signing.
 

Pmarszal

Involved In Discussions
#9
Our QMS system requires a user name and password at the time of entering the system, it then requires a password at the time of signing.
 

Dobby1979

Involved In Discussions
#10
OK, thanks. That makes more sense then.

We currently have users sent an email (from a site that you log in to via a user name and password) but they can just click on the link, hit sign on the document and away they go. I am working with the software tool company to have a password prompting you after they hit sign. This would then make things compliant
 
Thread starter Similar threads Forum Replies Date
S 21 CFR Part 820.40(b) Clarification on Required Document Approvers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A Charge-in Components - 21 CFR Part 211 Requirements Clarification Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
K IPC-610 Section 10.4.2.2 clarification - Distance to be measured Various Other Specifications, Standards, and related Requirements 0
M Off-Label Use - Clarification of FDA Policy US Food and Drug Administration (FDA) 1
T Implant Card - Article 18.1(a) and MDCG 2019-8 clarification EU Medical Device Regulations 3
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
M Informational TGA Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs Medical Device and FDA Regulations and Standards News 2
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
Q ISO 3310 Clarification Help - Aperture sizes for sieves used for particle sorting Other ISO and International Standards and European Regulations 2
S The Severity of a Medical Device Hazard - Risk Analysis Clarification ISO 14971 - Medical Device Risk Management 6
M 8.3.2.3 Development of products with embedded software - request for clarification IATF 16949 - Automotive Quality Systems Standard 1
M FDA News USFDA Draft Guidance – Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment Medical Device and FDA Regulations and Standards News 0
T Clarification on MDR - Article 18(d) - Implant Card EU Medical Device Regulations 14
S QS, RS deflection - clarification wanted IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A ISO 2859 Single Sampling - Clarification regarding the sampling table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
S Requirements for Interval Measurement test & Frequency Response test clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Clarification regarding tests in IEC 60601-2-25 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Internal Audit clarification - How to perform the audits IATF 16949 - Automotive Quality Systems Standard 6
V Clarification - Hydrogen De-embrittlement Manufacturing and Related Processes 6
K UDI Direct Marking Compliance Date Clarification and one other UDI question Other US Medical Device Regulations 0
N Applied Parts Classification Clarification - Breast Pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
V Clarification of Injection part shrinkage ratio Manufacturing and Related Processes 1
J ISO 9001:2015 8.2.3 - Review of Requirements (Clarification on compliance) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Health Canada Recall Definition - Seeking Clarification Canada Medical Device Regulations 5
Q ISO 9001:2015 - Clarification in 6.1.2 Note 1 (Options to Address Risks) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Clarification of threaded ring gage calibration procedure/requirements General Measurement Device and Calibration Topics 2
M Clarification on Calibration/Verification Records 7.1.5.2.1d (IATF 16949) General Measurement Device and Calibration Topics 11
B Clarification on interpretation of some EN ISO 14971:2012 & IEC 62304:2006 req's ISO 14971 - Medical Device Risk Management 46
S AS9102 - Clarification - PO asking for an Assembly at Rev B (Print at Rev C) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B Clarification of ISO 9001:2015 Clause 8.5.6 Control of Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Integrated Phased Processes - AS9100D cl. 8.1 Operational Planning - Clarification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Monitoring and Measuring Resources (7.1.5) - Clarification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
dubrizo Clarification Requested in 6.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
F TS 16949 Clause 7.2.1 - Note 2 - Recycling program - Clarification IATF 16949 - Automotive Quality Systems Standard 4
K EN ISO 15223-1:2012 Clarification or Examples on when to use Safety Symbols Other Medical Device Related Standards 3
S Clarification regarding types of processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Clarification of Applicability of TS 16949 Requirements to a Non-Automotive Business IATF 16949 - Automotive Quality Systems Standard 13
M Request for clarification on TS 16949 Clause 5.6.1.1 IATF 16949 - Automotive Quality Systems Standard 5
Q Configuration management clarification and example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Clarification in organizing required documents for ISO 27001 IEC 27001 - Information Security Management Systems (ISMS) 6
J Definition Actively Manufacturing - ISO 13485 Definition and clarification Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 8
T Early Research & Development - ISO 13485:2003 requirements Clarification ISO 13485:2016 - Medical Device Quality Management Systems 34
B Detachable Power Supply Cable Connection ESD Clarification IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
D NIST HDBK 44 Table T.3. Class III Tolerance in Divisions Clarification General Measurement Device and Calibration Topics 4
M UDI - Direct Marking and Reprocessing Clarification Other US Medical Device Regulations 12
E Clarification on Document Signatories under ISO9001 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P ISO 27001:2013 Clause 4.1 and 4.2 Clarification and Guidance IEC 27001 - Information Security Management Systems (ISMS) 13
C Positional Tolerance - Bonus / Datum Shift / ASME Y14.5M - Clarification Various Other Specifications, Standards, and related Requirements 9
K Free from any Undue Internal and External Pressures - 4.1.5b clarification General Measurement Device and Calibration Topics 2
B MSA 4th edition reference manual - Page 120-121 Clarification Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6

Similar threads

Top Bottom