21 CFR Part 11 Electronic Signatures / Records Strategies for Implementation and Compliance. Presentation by Daniel E.Worden March 25, 1999 Barnett International Workshop London. AN OPENING THOUGHT. "We are much more likely to act our way into a new way of
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Electronic Signatures / Records
Strategies for Implementation and Compliance
Presentation by Daniel E.Worden March 25, 1999
Barnett International Workshop London
"We are much more likely to act our way into a new way of
thinking than think our way into
a new way of acting"
N / A
+ Sec. 11.70
+ Sec. 11.70
+ Sec. 11.70
+ Sec. 11.50
+ Sec. 11.100
+ Sec. 11.200b
+ Sec. 11.50
+ Sec. 11.100
+ Sec. 11.200a
+ Sec. 11.300
[ quality management systems ]
-Data Acquisition & Reporting
-Remote Data Entry
-Case Report Form Systems
-Clinical Data management
-Adverse Event Reporting
-Clinical Supply Systems
-Statistical Analysis Systems
-Manufacturing Execution (MES)
-Maintenance Management (MMS)
-Calibration Management (MCS)
-Facility Management Systems
-Enterprise Resource Plan ( ERP)
-Supply Chain Planning (SCP)
-Computer Assisted NDA
*GISP- Good Information
“The Agency believes that if it is important enough that a record be signed, human readable displays of such records must include the printed name of the signer, the date and time of signing, and the meaning of the signature”.
Example: a message from a firm’s management to employees instructing them on a particular course of action may be critical in litigation.
Electronic record is defined as “any combination of text, graphics, data, audio, pictorial or other information representation in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system.”
Time to Market
“Quality” of Development
Link to Market & Customer Information
Cross-functional process flows
Cross-functional Information flows
Continuous Process Improvement
Global resource management
Accelerated Review &
INFORMATION STRUCTURE &
Global Information Architecture
INFORMATION SYSTEMS TECHNOLOGY
Questions and answers from Paul Motise at various industry meetings, as well as conversations and his e-mail updates
Q: Can a firm which maintains regulatory records in computer files be exempt from FDA’s signature rule if periodically the firm prints paper hard copies of all documents as it’s official record?
A: Paul Motise says no. On 10/22/97 US District Judge Paul Friedman nullified a National Archives Regulation authorizing all Government Agencies to erase electronic documents if paper is archived. Example: Spreadsheet shows results but not the algorithm.
Q: What must the audit trail contain?
A: Date/time of operator entries that create, modify, or delete information and who did what, wrote what, and when.
Q: Can an audit trail be paper?
A: No. It must be a computer generated electronic record.
Q: Must an audit trail be signed?
A: No. It must be independent of the operator and operators must not be able to sign the audit trail.
Q: Will an electronic signature with only a date stamp be acceptable or does the time of day need to be included?
A: Time is vital and must be included.
Q: Do you really expect to have certifications from every regulated company as in part 11.100, even if they are only using electronic signatures for open systems (such as e-mail) and are not using electronic signatures for collecting original data, authorizing documents or electronic submissions?
A: Yes. We are asking for that certification from every company that is using an electronic signature to meet FDA signature requirements. It doesn’t matter if it is open or closed.
Q: In the GLPs [Part 58.81(a)] the requirement is that changes to SOPs “be authorized in writing by management”. Does 21CFR11 broaden the meaning of “in writing” to include “be authorized in writing or electronically by management”?
A. In GLPs, if you have a particular record, then Part 11 applies to the record. If you are going to create an endorsement electronically, then Part 11 applies. If a record is required by FDA then Part 11 applies.
Q: If I scan in CRFs to get into a report and I will be signing the final report as the preparer of the submission, would that be acceptable to the agency?
A. Yes. This is a hybrid system, but for the electronic record you will apply an electronic signature to the entire thing. What is signed should be protected so that later on nothing can be switched.
Field Notice FMD 146 10/22/97 tells investigators to check the ORA Intranet site to determine if an electronic signature certification has been filed prior to arriving at the inspection site.
Guidance to FDA Inspectors for Making and Maintaining Copies of Electronic Records:
1) Use digital signature software to authenticate your copy file; signature verification would detect any post signing record changes.
2) Obtain an affidavit from the firm confirming that the copy is accurate and complete.
3) Place the disk or tape holding your electronic copy in a container under official seal and documenting a chain of custody for the container in a manner similar to official samples.