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: the ISO 9000 series, FDA 21 CFR Part 11, EU GMP Annex 11, HIPAA, and Sarbanes-Oxley. 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 module includes the event logging extensions mentioned above and 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, refer to License Management). In addition to this, vault-specific properties of the audit trail must be activated (see Document Vault Advanced Properties). Electronic signatures are automatically enabled with the license code.
More information
For more information on the Electronic Signatures module related extensions for event logging and electronic signatures, refer to Event Log and Electronic Signature.
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 [email protected].