Electronic Signing and Compliance

Companies using M-Files can manage their documents and processes efficiently and with quality. M-Files can be used for compliance with various specifications, good manufacturing practices, general procedures, and documentation according to standards. Moreover, M-Files provides functions to manage and monitor general documents associated with daily business.

M-Files also meets the special requirements related to records and following various specifications and standards. For example, M-Files complies with the following standards and guidelines:M-Files can also be used to implement TLL-4-compliant data systems (TLL-4 is a data security classification used in public administration and defense forces).

M-Files supports the administration of electronic records and signatures in compliance with FDA 21 CFR Part 11. This involves maintenance of the detailed audit trail of actions performed on the documents, secure monitoring of individual actions, and certification of electronic signatures with usernames.

Activation

The Electronic Signatures and Advanced Logging module includes the event logging extensions mentioned above and the electronic signature functionality. The module is available for a separate fee.

For you to activate the module, an appropriate license code must be activated on your system. The license is provided on a subscription basis. Activate or update the license code in M-Files Admin (for more information, see Managing Server Licenses). In addition to this, the audit trail features of the vault must be activated (see Document Vault Advanced Properties). If you do not have M-Files Compliance Kit installed, you also need to add the electronic signature metadata structure to your vault manually (for instructions, see Metadata Definitions for an Electronic Signature Object).

More information

For more information on the Electronic Signatures and Advanced Logging module related extensions for event logging and electronic signatures, refer to Vault Event Log and Electronic Signatures.

M-Files can also be used to address other standards, quality management systems, compliance requirements, guidelines, and procedures and processes in different fields. Log entries, audit trails, version history, and electronic signatures form one set of functions that M-Files can offer. To find out how M-Files can support your business by complying with applicable standards and specifications, please contact us at sales@m-files.com.