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The COVID-19 pandemic forced the FDA to reduce the number of inspections it could conduct, and this resulted in fewer warning letters related to clinical trial issues. But despite that, 94 drug GMP warning letters were issued, mostly for poor sterility assurance, nitrosamine impurities, lack of data integrity, and basic GMP failures.

Companies that receive warning letters from the FDA are expected to implement remediation procedures that can be even more expensive than complying in the first place.

It affects the laboratory’s credibility with regulators — not just the FDA but also other global regulators, leading to increased scrutiny. More scrutiny means more inspections — and it’ll slow down the overall pace at which clinical trials can be conducted. Repeat offenders may have to pay hefty fines as well as sign a consent decree of permanent injunction that will bind them to be compliant in perpetuity.

The contract research organization (CRO) or contract manufacturing organization (CMO) receiving a warning letter will need to inform the sponsors, who may even withdraw support. It can impact the company’s business/financial performance, affect company valuations, and reduce the overall reputation.

A data-driven quality management process is critical to conducting clinical trials. At ComplianceQuest, we recently published a whitepaper titled ‘Integrating Quality into the Clinical Workflow’.

To learn more about running a quality-centric clinical trial process with next-generation automation, download the whitepaper here: https://www.compliancequest.com/whitepaper/quality-ctms/

Common Reasons for Receiving Warning Letters

The four common regulations cited in FDA’s investigation observations for the year FY2020 include:

  • §211.192 Investigations of discrepancies
  • §211.22(d) Quality control
  • §211.160(b) Lab control
  • §211.100(a) Production and process control

In all these, written procedures and meeting specifications feature prominently.

CROs/CMOs require a proactive approach where they implement document control best practices to avoid FDA warning letters. A clinical trial management system integrated with a quality management system can help CROs with:

  • Establishing Document Control Procedures: This includes:
    • Version control and marking records with current dates
    • Creating and filing SOPs with easy access
    • Setting up permissions to prevent unauthorized individuals from changing key documents such as SOPs, specifications, and testing methods
  • Integrating Document Control with Quality Processes: The written procedures should be effectively integrated with document control systems and procedures into their overall quality process.
  • Protect Data Integrity: Data integrity is extremely critical in FDA’s view, and it expects data to be attributable, legible, complete, original, and accurate. Essential document control practices for protecting data integrity include:
    • Retaining original records or true copies
    • Documenting all data from every test
    • Real-time data recording
  • Reducing Paper Records: Paper records are a common sight in clinical research organizations. But given the need for documentation and regulatory compliance, digitalization will minimize errors and other associated challenges such as data errors, storage restrictions, difficulty in accessing important documents, version control, and so on.

Reduce FDA Warnings with ComplianceQuest

ComplianceQuest CTMS, powered by Cloudbyz, along with CQ EQMS, offers an integrated solution to streamline and automate processes across the clinical trial management workflow. It helps both quality and clinical leaders with running a quality-first approach to conducting trials.

This approach can also help protect data integrity by pulling the research results data directly from the LIMS (Laboratory Information Management System).

Some of the other key features/capabilities that can help improve efficiency and compliance include:

    1. Be Inspection Ready at All Times: CQ Clinical meets operational needs and compliance requirements by enabling audit trail features that make it easy to conduct internal and external audits on a regular basis. CQ Clinical facilitates collaboration between employees for audits, organizing resources, and staff recruitment to accompany auditors through email communication.
    2. Ease of Document Management: The eTMF feature in CQ Clinical enables storing of essential documents with a click of a button and through the drag & drop feature. The folders can be structured according to the format requested by the DIA or customized. It also offers audit tracking and an automated process for document/change approval. The Clinical solution is also integrated with the CQ EQMS, enabling document workflow management and collaboration across teams.
    3. Controlled Documentation: The integrated Clinical and EQMS solution ensures version control of important documents such as SOPs to eliminate the possibility of human errors. It is also a secure solution that establishes proper permissions to prevent unauthorized access and changes to the documents.
    4. Streamlined Audit Processes: The Audit feature ensures simplified audit trail management in the initial meeting of an audit, during the audit process, and all subsequent communications with the FDA.
    5. Change Management: Any change needs to be documented and shared with relevant stakeholders to ensure the alignment of processes and resources to the new requirements. The Change Management feature ensures collaboration and governance for efficient changes across all clinical trial processes.
    6. CAPA: In case of any incidents or potential problems, it is necessary to identify the root causes that can help take effective corrective and preventive action. Automating the CAPA process also provides access to incident-related data that facilitates identifying trends and implementing measures to prevent future recurrence of the issues.
    7. Complaint: Complaints are a source of feedback that can help with continuous improvement and minimize errors and nonconformances. The Complaint Management solution can help automate the workflow from ingestion to closure and improve compliance as well as the clinical trial outcomes.
    8. Nonconformance: Centralizing the clinical trial process can ensure quality across the organization and sites across locations, thereby minimizing errors and the chances of receiving warning letters.
    9. Risk: The FDA stresses on taking a risk-based approach to improve trial outcomes, patient safety, and product quality. The Risk Management solution helps CROs and sponsors identify risks, prioritize them based on severity, and address critical risk areas first to improve compliance.
    10. Supplier: The suppliers and contractors are a crucial link in ensuring compliance and product quality. CQ Supplier Management solution helps evaluate suppliers based on requirements, assigning risk scores, tracking and monitoring performance, and taking timely action to ensure meeting quality goals.
    11. Training: In the fast-changing regulatory environment, identifying gaps in skills and capabilities and implementing a continuous learning program to propel organizational growth is very essential. The Training Management program helps customize training programs for the employees, track progress, and assess their skills for effectiveness.

Overall, any clinical research process requires its own unique set of procedures, processes, and resources. A next-gen CTMS Solution, such as the one we offer at ComplianceQuest, will certainly make life easier for clinical and research teams. But only a CTMS is not enough. In today’s world of evolving regulations and complex products, it is a good idea to integrate quality into the clinical workflow.

Request for a personalized demo here.

For more information, listen to this webinar on ‘Need for Clinical AND Quality Management in Clinical Research’: https://www.compliancequest.com/webinar/need-for-clinical-management/

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