Electronic Records and Signatures - 21 CFR Part 11

Marc

Fully vaccinated are you?
Staff member
Admin
#1
The pharmaceutical industry is moving towards the electronic records/electronic signatures and the FDA has issued regulations regarding electronic records/signatures (21 CFR Part 11). You may review the regulation by visiting the FDA web site, www.fda.gov/ora/compliance_ref/part11/

[This message has been edited by Marc Smith (edited 05 April 2001).]
 
Elsmar Forum Sponsor
M

mboteo

#2
adobe acrobat

Anybody knows if Adobe Acrobat suffices using it's electronic signature option, to comply with this.

Our corporate headquarters want us to use Lotus Notes, but cost wise I am more interested in transferring my MS Office documents into PDF files.

S.
 

Marc

Fully vaccinated are you?
Staff member
Admin
#3
I can't say for sure on this. I do get the 21cfrpart11 posts from the 21cfrpart11 folks at www.yahoogroups.com responses e-mailed to me but there are so many I really don't read them very often any more. The 21cfrpart11 folks do have a web site but I can't remember the url off hand.

QualPro - can you help here?
 
Q

QualPro

#4
21 CFR Part 11

Off hand I do not know of a website for 21 CFR Part 11, other than the FDA main website (in the CFR section), which puts you directly into the CFR text.

Also, the FDA does have "guidance documents" on 21 CFR Part 11 that you can link to from the main FDA website at www.fda.org.

In short, the FDA website is the best place to start.

Regarding Adobe Acrobat, I doubt if it is an appropriate tool, since it "probably" does not provide the audit trail and security required.

This is an area of great interest to me. I will be doing some research on this subject since I plan on developing a tool for small companies to achieve electronic signature. I am willing to share notes if you are interested.



QualPro
 
Thread starter Similar threads Forum Replies Date
D Question on electronic signatures and initials on batch records ISO 13485:2016 - Medical Device Quality Management Systems 3
Ron Rompen Computerized Electronic Signatures on Inspection Records Records and Data - Quality, Legal and Other Evidence 8
K Application of Electronic Records & Signatures in Calibration Management Software Document Control Systems, Procedures, Forms and Templates 0
M Correcting Electronic QMS Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
qualprod From paper to Electronic (records) in the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Integrity of electronic digital records - Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational USFDA – Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Stand Medical Device and FDA Regulations and Standards News 0
I GMP 21 CFR Part 11 Electronic Records Compliance Project Help Qualification and Validation (including 21 CFR Part 11) 9
R Electronic (Online Database) Calibration Records General Measurement Device and Calibration Topics 4
M Control of email (and other electronic media) as Records - 4.2.4 Records and Data - Quality, Legal and Other Evidence 10
A Electronic Maintenance Records stored in a machine ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Is Handwritten Raw Data required to keep with Electronic Records? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D 21 CFR 11 Tools Validation - Electronic Document and Records Control Qualification and Validation (including 21 CFR Part 11) 5
N Converting Paper Records to Electronic Format Records Document Control Systems, Procedures, Forms and Templates 6
B How to implement 4.2.4 - Disposition of Records in Electronic Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Electronic Record Control (Specifically editable records not fixed documents!) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Requirements for keeping Records in Electronic Format Records and Data - Quality, Legal and Other Evidence 15
V 21 CFR Part 11 Electronic Data Storage Requirements vs. Paper Records Qualification and Validation (including 21 CFR Part 11) 2
D Transferring Paper Records to Electronic Record Archival Records and Data - Quality, Legal and Other Evidence 4
J How to Link Electronic Records (510k Documents) to Handwritten Signature Other Medical Device Regulations World-Wide 16
T Electronic Records and Software Development ISO 13485:2016 - Medical Device Quality Management Systems 7
C Paperless Electronic Documents and Records - Softcopy to Electronic Document Control Systems, Procedures, Forms and Templates 8
K Paperless Electronic Records in a Machine Shop Records and Data - Quality, Legal and Other Evidence 8
M FMEA Interface Matrix - Analyzing risks of electronic health records system FMEA and Control Plans 4
M Risk Management Standards - Hospital Information System (electronic health records) Hospitals, Clinics & other Health Care Providers 4
M Electronic Medical Records (EMR) strategy Software Quality Assurance 1
J Protocol to validate the use of Electronic Records like DHRs, NCMRs, Validations ISO 13485:2016 - Medical Device Quality Management Systems 3
I Electronic Training Records which show Evidence that People have been Trained Records and Data - Quality, Legal and Other Evidence 29
E Electronic Records Transmission to Customers Records and Data - Quality, Legal and Other Evidence 8
Crusader Preventive Maintenance - Electronic Records Deleted/Erased OR Are Records Required? Records and Data - Quality, Legal and Other Evidence 62
M How to Control Electronic Records Records and Data - Quality, Legal and Other Evidence 5
D FDA Compliant Electronic Records - Requirements, definitions, maintenance and archive Qualification and Validation (including 21 CFR Part 11) 2
A Traceability - No traceability records back to the supplier - Electronic Components Records and Data - Quality, Legal and Other Evidence 5
D ISO 13485 - Part 11: Electronic Records - Small Biotech Company - What is required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Hardcopy vs. Electronic Training Records - Eliminating Hardcopy Records Records and Data - Quality, Legal and Other Evidence 13
Q Records: Electronic E-mail Retention Requirements Records and Data - Quality, Legal and Other Evidence 2
J Electronic Document and Records Control Software Records and Data - Quality, Legal and Other Evidence 28
D Inspection and Test Records - Question on electronic retention Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
A Electronic Records for FDA - Canned computer program for our Corrective Action system Records and Data - Quality, Legal and Other Evidence 3
M Paperless Electronic Document and Records Systems Software Records and Data - Quality, Legal and Other Evidence 19
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 28
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
blackholequasar Price Gouging? (Electronic components) Manufacturing and Related Processes 9
H Prodigit DC Electronic Load - Drawing current but showed 0 on the screeen Manufacturing and Related Processes 0
M Design Control - Management of Electronic CAD files Design and Development of Products and Processes 14
A Electronic forms QMS Document Control Systems, Procedures, Forms and Templates 12
S Reporting REACH - Electronic components distributor REACH and RoHS Conversations 5
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
M MDR - eIFU - When you can supply an electronic IFU instead of a paper IFU EU Medical Device Regulations 6

Similar threads

Top Bottom