Mythri Raghunandan

Mythri Raghunandan

Five Ways to Avoid FDA Warning Letters Through Automated CTMS Solution3 min read

The violations of regulatory compliance may lead to the issue of a Warning Letter FDA WARNING LETTER AND FDA FORM 483.  Over the recent years, most of these warning letters are due to non-compliance or negligence in the audit trail documentation practices.

Most frequent reasons to Issue FDA warning letters

Document control best practices to help companies avoid FDA warning letters

  1. Establish Document Control Procedures: The FDA commonly issues warning letters over the lack of document control procedures:
  • The means no backdating records, which the agency has noted as a problem in the past.
  • The old copies of SOPs taped up next to a workstation.
  • Permissions need to be set up that prevent unauthorized individuals from changing key documents such as SOPs, specifications and testing methods.
  1. Integrate Document Control with Quality Processes:  The written procedures should be effectively integrated document Control systems and procedures into their larger quality process.
  2. Protect Data Integrity: The  FDA expects data to be attributable, legible, complete, an original or true copy 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.

An automated QMS can help protect data integrity by pulling the research results data directly from the LIMS.

  1. Control Paper Records: Best practices for controlling paper records include:
  • Treating forms, worksheets, and notebooks as controlled documents.
  • Making sure all blank forms issued are numbered and reconciled.
  • Retaining incomplete forms and recording why they were replaced.
  • Identifying unofficial notebooks, stamping notebooks for official use and inspecting pages for gaps.

Cloudbyz CTMS Solutions integrated with Documents control best practices to avoid FDA warning letters

  1. Be Inspection Ready: Cloudbyz CTMS meets operational needs and compliance requirements, the audits trial features are enabled that helps to conduct internal and external audits on a regular basis.  Cloudbyz CTMS enabled to inform the employees about audits, resources needed and staff recruitment to accompany auditors through email communication.
  2. eTMF for enhanced documentation system: The eTMF feature in Cloudbyz CTMS enables to store the essential documents with a click of a button and through drag & drop facility. The folders can be structured according to the DIA or customized, with audit tracking and automated document approval process hassle-free.
  3. Access controlled documentation Feature:  Cloudbyz CTMS ensures an automated document control system including SOPs with a proper version that eliminates the possibility of human errors. Cloudbyz CTMS also establishes proper permissions to prevent unauthorized access and changes the documents.
  4. Develop an audit trial compliance culture: Cloudbyz CTMS ensures simplified audit trail management in the initial meeting of an audit, during the audit process, and all subsequent communications with the FDA.
  5. A Hyper-Adaptive Quality Management Software: Cloudbyz CTMS ensures a modern and hyper-adaptive quality automation solution that will ensure compliance today and into the future that addresses new business and regulatory changes.


    • FDA: Food and Drug Administration
    • CTMS: Clinical Trial Management System
    • SOP: Standard Operating Procedure
    • QMS: Quality Management System
    • LIMS: Laboratory Information Management System
    • eTMF: Electronic Trial Master File
    • DIA: Drug Information Association




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