Professional Documents
Culture Documents
APPROVALS:
Name Signature Date
REVISION HISTORY:
Revision Initials and Date Summary of Changes
00
- Montrium has inserted instructions in blue text into this document to help you
understand the information in each section. Once you have modified this
document to meet the specifics of your organization, please delete the blue text.
- Blue italicized text in this document indicates elements which should be revised
or completed by you so that the text meets your company’s needs and quality
system requirements. Once you have completed this information, please remove
the italics in the document.
Confidential Page 1 of 10
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Electronic Signatures Management [Effective Date]
Contents
1.0 PURPOSE ................................................................................................................................................................................. 3
2.0 SCOPE ...................................................................................................................................................................................... 3
3.0 DEFINITIONS ............................................................................................................................................................................ 3
5.0 PROCEDURE............................................................................................................................................................................. 6
Confidential Page 2 of 10
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Electronic Signatures Management [Effective Date]
1.0 PURPOSE Commented [MTM1]: In this section, you should insert a short
statement describing the purpose of the procedural document to
The purpose of this procedure is to establish a process for obtaining and tracking electronic describe why it is needed, and what it is being implemented to
accomplish.
signatures in compliance with US FDA 21 CFR Part 11 and EU Annex 11 requirements.
If the text in Section 1 is acceptable, you need only to insert your
This procedure also establishes when an electronic signature may replace a written signature Company name to replace the highlighted field.
and when an electronic record may replace a paper document record.
2.0 SCOPE Commented [MTM2]: In this section, you should insert a short
statement describing the scope of the procedural document,
This procedure applies to all Company Name employees and consultants, and governs all uses of outline the reason the document was created and define its
intended audience.
electronic signatures and electronic records that are generated as part of Company Name
regulated activities. If the text in Section 2 is acceptable, you need only insert your
Company name to replace the highlighted field.
This procedure may also apply to additional activities which may include, but not be limited to,
the generation of electronic communications, transactions, contracts and any other document
or record that requires a signature.
This procedure does not apply to paper records transmitted by electronic means such as fax, or
to word-processed documents that are subsequently printed, authorized (signed and dated) and
maintained as paper records.
Confidential Page 3 of 10
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Electronic Signatures Management [Effective Date]
3.2.8 Non-Repudiation
3.2.9 Record
Confidential Page 4 of 10
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Electronic Signatures Management [Effective Date]
Commented [MTM5]:
Commented [MTM7]:
Confidential Page 5 of 10
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Electronic Signatures Management [Effective Date]
5.0 PROCEDURE
5.1 Selecting an electronic signature method Commented [MTM8]:
Commented [MTM9]:
5.2 Minimum requirements for the use of an electronic signature Commented [MTM10]:
5.2.2 Assignment
Confidential Page 6 of 10
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Electronic Signatures Management [Effective Date]
5.5.1 Reporting
5.5.2 Sanctions
Commented [MTM13]:
Confidential Page 7 of 10
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Electronic Signatures Management [Effective Date]
Severity Sanctions
(Human generated deviation)
Minor
Minor Repeated
6.0 REFERENCES
Document Number Document Title
<enter title to the application Vendor Management procedure or Validation
Document Number
procedure/plan>
<enter title to the applicable user account management procedure or hiring
Document Number
and termination policy>
Confidential Page 8 of 10
Document No
STANDARD OPERATING PROCEDURE [Document Number]
<ENTER COMPANY LOGO> Revision: [00]
TITLE Effective date
Electronic Signatures Management [Effective Date]
7.0 Appendices
7.1 Appendix A: FDA Letter of Non-Repudiation Agreement
(http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm113964.htm)
[Company Letterhead]
[Today’s Date]
[Hand-written signature]
[Name of Company Representative]
[Company Representative Title]
Confidential Page 9 of 10
FORM Form No
<ENTER COMPANY LOGO> [Form number]
TITLE
Form Version: [00]
Error! Unknown document property name.
Non-Repudiation Statement:
Confidential Page 10 of 10