FDA Compliance Management Software

EtQ's FDA Compliance Management Software system is a flexible software package that guides companies through compliance with GMP, ISO 13485, 21 CFR Part 11, ISO 9000, and similar standards for FDA Compliance.
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Electronic Signature Binding

EtQ's FDA Compliance Management Software automatically and securely binds the authenticated user's electronic signature. EtQ ensures that the user has signed onto the system and exposed their signature via the forced authentication process, as required by 21 CFR Part 11. Authentication is required each time a document is processed.

Audit Trail

EtQ securely and automatically posts any and all field changes to a separate database. The Audit Trail includes the field's old value, new value, name of the user who made the change, and date and time.

Controlled/Secure Access

EtQ's robust security model ensures that your FDA Compliance Management Software System and data have the highest security. Information access is controlled by a username, ID, password, form, form section, field and workflow.

FDA Compliance Package

Comprehensive validation documentation is an integral part of the EtQ Implementation process. EtQ's FDA Compliance package ensures compliance to FDA initiatives including 21 CFR Part 11.

Enhanced Password Security

Automatic password aging with configurable expiration and warning periods, as well as automatic protection against repeated attempts to log in without proper username and password.

Enhanced Audit Trail Field

Enhanced Audit Trail feature allows users to "mouse over" EtQ fields, displaying the Audit Trail for that particular field.

FDA Compliance Validation

  • Validated 21 CFR Part 11 compliance with largest customers in the industry
  • Single interface for all applications and administration - no need to validate client at all

FDA Compliance Audit Trail

Display the Audit Trail for a specific field, a specific event (phase) or for the entire record

  • Audit Trail can be enabled for specific phases or specific fields
  • Audit Trail can be saved as MS Excel Spreadsheet
  • Audit Trail includes user name and ID, date and time, record phase (reason for change), old data, new data, and comments
  • Configuration Management: Ability to track changes made to configuration settings within the application in the Audit Trail
  • Track changes to user accounts (i.e. update, enable, disable) in the Audit Trail
  • Track changes to field values in the Audit Trail

FDA Compliance Security & Electronic Signatures (21 CFR Part 11)

  • Electronic Signatures and Records: displays the user name (Signer), ID, Record Phase, Activity and/or Event, and meaning of the signature
  • Secure access using SSL encryption
  • Electronic Signature (21 CFR Part 11) consists of user name, date and time, time zone, and meaning of the signature (i.e. record phase, name of activity, etc)
  • Supports different time zones by using GMT offset - uses Global date formatting (International Data Format - GMT)
  • User name and password is used to verify 21 CFR Part11, Electronic Signature
  • Authentication required to access any part of the system
  • Closed system
  • Administrator access level can be defined to set up security
  • Configurable password expiration dates (expire password after X number of days)
  • Require users to change passwords when they log in for the first time

FDA Compliance Workflow

  • Activities can be restricted to the designated person responsible
  • Enables electronic signature (21 CFR Part 11) binding
  • Allow access to all records until they are no longer needed
  • Records can be displayed on screen, in reports, electronically, or exported into a flat file format
  • Create workflow configurations to enforce record routing
  • Make specific events require a comment (i.e. must provide a comment for all rejected, archived, restored actions)
  • Send records with different access control rules to separate archives for purging or classification
  • Keeps a record of every version of an attachment when it is modified
  • Automatically promote configuration changes between environments (e.g., from Development to Test to Production)

With its world-class flexible workflow, collaborative platform, EtQ has developed a unique niche to support enterprises involved in various compliance management initiatives such as; cGxP (FDA), ISO 13485, ISO 9001:2008, ISO/TS 16949, ISO 14001, ISO 22000, AS 9001, TL 9000, OHSAS 18001, RoHS, Sarbanes-Oxley, HACCP, SQF and similar standards for compliance and regulatory management.