FDA Regulatory Compliance Management Software

Through configurable workflow and a best-practices approach, EtQ's solution provides all the tools you need to maintain GMP Compliance within your organization.

FDA Regulatory Compliance Software Package

EtQ's QMS for Life Sciences is an integrated quality management and FDA Compliance Software system that exceeds GMP standards, including ISO 13485, ISO 14971 and 21 CFR Part 11 compliance requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. These modules are tightly integrated to deliver a best-in-class GMP Compliance Software solution that will improve compliance and quality for your industry.

Connected to the Production Systems

EtQ Connectors close the gap between production systems and the quality compliance system. Modules like Nonconformance Management and Complaint Handling Software connect to ERP and CRM systems to fully automate the creation and assignment of events. Production systems can then be automatically updated throughout the event resolution process. For example, to trigger the release of product based on the MRB disposition; or update the complaint status based on the CAPA investigation results.

EtQ's Compliance Management Software system is a flexible software package that guides companies through compliance with GMP, ISO 13485, 21 CFR Part 11, ISO 9001, and similar standards for FDA regulatory compliance.

Electronic Signature Binding

As part of meeting regulatory requirements, companies must ensure that they are providing full traceability and accountability on records with their FDA Compliance Software Solution. Part of this requirement is the Electronic Signature, which captures the user’s digital signature for each step in the compliance management process. EtQ's Regulatory 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

Life Sciences organization strive to achieve a state of inspection readiness, when automating their solution through their regulatory compliance software solutions. This means that they want to have a logical and traceable chain of custody and event management from event detection to event correction. 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. This provides value to companies in recording not only the field changes, but the requirements management of regulatory compliance software components, which provide increased visibility for validation activities associate with software changes.

Controlled/Secure Access

The FDA and regulatory compliance requirements within organization are often faced with security challenges within their compliance management software solutions. Having the right level of security and protection of the information with the solution becomes a critical component to maintaining fda regulatory compliance. EtQ's robust security model ensures that your compliance software for both FDA and internal requirements has the highest security. Information access is controlled by a username, ID, password, form, form section, field and workflow. This is true for both In-house or cloud deployments of EtQ’s FDA compliance management software solutions.

FDA Compliance Software Package

As part of FDA regulatory compliance, companies that deploy a compliance management software solution must complete computer system validation of the software. This process is often a challenge for organizations, and having a robust validation solution is important to meeting the FDA’s regulations around GAMP 5. EtQ’s comprehensive validation documentation is an integral part of the EtQ implementation process. EtQ's GMP compliance software ensures FDA regulatory compliance to initiatives including 21 CFR Part 11.

Enhanced Password Security

Ensuring security of information within the compliance management software solution is important to FDA compliance, but so is user-based security. EtQ’s FDA compliance management software platform features 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. This way you can ensure that all user information is protected and secure, and mitigates risk of unauthorized access.

Enhanced Audit Trail Field

EtQ’s compliance management solution is built with accountability and traceability in mind, but EtQ is able to go beyond simple audit trail logging to include more enhanced features for organizations to ensure compliance. EtQ’s FDA solutions come with an enhanced audit trail feature which allows users to "mouse over" EtQ fields, displaying the audit trail for that particular field. This adds an additional layer of traceability to the compliance platform, making sure that field revisions are tracked and visible for review.

FDA Regulatory Compliance Validation

Computer system validation is a key component to regulatory compliance, and EtQ has built solutions with validation in mind. Whether you are deploying within your in-house infrastructure or in the cloud, EtQ has a complete validation solutions to meet the needs of the FDA and your business requirements. EtQ has been audited and has validated 21 CFR Part 11 compliance with largest customers in the industry, and has complete solutions for documenting, testing and promoting validated environments for regulatory compliance. Since EtQ Reliance FDA compliance management solution is Web-based, there is no client validation necessary – the EtQ administration and applications reside on a single environment. Beyond the validation package that EtQ offers is the eValidator utility. This robust tool enables you to automatically run test scripts and display the results in a comprehensive report – this automation of test scripting results in a major reduction of time to value in validation – upwards of 400% time savings.

Electronic Submissions to the FDA (eMDR)

As part of the FDA’s mandatory electronic MedWatch reporting initiative, companies are required to electronically submit any adverse events to the FDA. EtQ Reliance eMDR Submission tool enables medical device manufacturers to electronically submit Medical Device Reports (MDRs) to the FDA directly through the FDA's automated gateway using EtQ eMDR. This methodology allows companies to electronically automate the quality process for medical device, and comply with quality and compliance standards, including those of the FDA.

FDA Regulatory 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 Regulatory 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 Regulatory 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, ISO/TS 16949, ISO 14001, ISO 22000, AS 9001, TL 9000, OHSAS 18001, RoHS, Sarbanes-Oxley, HACCP/HARPC, SQF and similar standards for regulatory compliance management.