How eQMS helps to avoid FDA Warning letters?
Article Context:
FDA Warning Letter
FDA issues warning letters to avoid compliance. Warning letters are issued when the FDA finds that a company from the life science industry is out of its way with the regulatory standards in quality processes or procedures in an expectation of remediation procedures implementation. Which is expensive and often leads to scrutiny, meaning – having to pay hefty fines and the manufacturing process slowing down due to product recalls or changes in procedures. In addition, if the company is in a contract, the sponsors may withdraw their consent leading to financial and reputation losses.
The most common reasons for life science companies receiving warning letters are
- Quality process control
- Improper documentation and control procedures
- Manufacturing procedures control
The life science industry is expected to proactively implement quality, document, and change control procedures to avoid FDA warning letters proactively. eQMS is a data-driven, quality-centric, next-gen automation-quality management system that can help organizations comply with global regulatory standards in the first place.
How to avoid FDA warning letters with eQMS?
eQMS, an integrated quality management suite, offers an automated intelligent quality process solution across the life sciences industries by streamlining the quality procedures and processes.
Below are the critical features of eQMS that help companies to improve efficiency and compliance.
Inspection-ready, non-editable automated audit trail
The eQMS enforces 21 CFR Part 11 compliant non-editable audit trails meeting operational and compliance requirements facilitating easy internal – external audits. The audit trail entails date-time stamps and user details of when who, and what changes are made in the process.
Non-Conformances – Corrective Actions and Preventive Actions
eQMS automates the CAPA Process by allowing the custom configuration of the workflow process and record life cycle management with the collection of incident-related data, which can be used to identify the root cause of the issue, prescribe corrective actions, and implement preventive measures preventing the recurrence of the problem in the future. Corrective and preventive action can be taken by effectively identifying the incident’s root causes or potential issues.
Additionally, the application allows the triggering of a CAPA from NC and other interlinked QMS modules with a click to effectively persuade the root cause of the incident. Furthermore, eQMS enforces a holistic view through the record-linking feature. The related records can be linked with a relation that gives the users a holistic view of related issues or occurrences and provides an easy way to analyze the trends.
Through centralizing the quality process, errors and warning letters can be minimized across the sites and organization.
Integrated Document and Change Management System
With eQMS – Quality Management Suite, essential documents can be reposited with just a click. Furthermore, it is possible to classify the documents, categorize the folders according to the regulatory standards, and customize them per the organization’s process. Additionally, the non-editable 21 CFR Part 11 compliant audit tracking offers an automated document life cycle management of who, when, why, and what changes are made to the document with user details and time stamp details [AK1] for controlled documents and the change process.
Further, eQMS integrated Document Management System enables a centralized repository for documents allowing the teams to collaborate and document workflow management of the followed procedures/best practices in their quality management process. Also, the document system enforces version control of critical documents like SOPs, work instructions, manufacturing procedures, etc., by establishing a proper permissions workflow preventing unauthorized access and document changes. The changes in the process are documented and shared with relevant teams to ensure the process’s alignment and resources with revised requirements. All the procedures and quality processes can be collaboratively managed and governed using the Change Management feature for efficient change.
Complaints Management
Customer complaints on product complaints can assist in continuous improvement. Their feedback minimizes errors and nonconformances. A complaint management system in the quality management process can transform complaints and dissatisfaction into opportunities and strategic advantages as it specifies how to handle complaints by automating complaint ingestion to the closure, fully addressing the customer’s concerns. Additionally, ensure that the organization understands the complaint, investigates its root cause, implements corrective actions, and prevents future repetitions of the problem, ensuring high customer satisfaction rates.
Quality Management System Suite allows the management of adverse events in a closed-loop fashion, enhancing the complaint-handling process. Also, it
- Streamline the complaints process
- Maintain documentation for complaints
- Evaluate products
- Investigate the root cause
- Reports and submissions related to global regulatory compliance
- Respond to customer inquiries.
- CAPAs can be triggered internally or externally
- Comply with regulatory requirements
Training Management System
In the rapidly changing regulatory environment, organizations must identify gaps in skills and capabilities to propel growth and deliver quality products in adherence to industry standards. By using the integrated Training Management System with a Quality Management System, organizations can solve regulatory quality process issues while simultaneously increasing productivity and addressing quality production issues.
eQMS training management is a cloud-based, intuitive solution designed to custom-create, assign, manage, execute, and monitor an organization’s training programs. It addresses all the training essentials, from tracking the training progress to qualifications, including certifications, and maintaining training records in a central repository to effective inspections and remaining compliant.
With Quality Training Management System,
- Execute Document-based training with an interlinked Document management system
- Track, monitor, and get visibility into trainee’s performance
- Create relevant training requirements based on job roles and organization units.
- Centralize all training activities and gauge the performance with assessments and grades.
The life sciences industry requires a unique set of procedures, processes, and resources. Hence, implementing an intelligent, next-gen eQMS solution will make regulatory compliance adherence easier for life sciences industries and wave off the FDA warning letters. But a Quality Management System alone is not enough. As regulations and products become more complex, it is imperative to incorporate an integrated Quality Management System in combination with Document Management, Change Management, Compliant Management, and Training Management.
Please write to us at sales@complianceg.com to get a personalized demo.