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Inspection Readiness: Is Your Trial Documentation Complete?

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The Trial Master File (TMF) conveys a study's chronology, and regulatory agencies worldwide view the TMF as a barometer of study health and compliance with Good Clinical Practice (GCP). For this reason, companies undertaking a clinical trial understand the necessity of agents scrutinizing the Trial Master File, while ensuring compliance. Just as importantly, while the focus of the TMF inspection ultimately drives the method or approach of the review, teams should expect that aspects of it will be conducted virtually from here on out.

Because of today's disconnected global landscape, remote inspections are challenging. TMFs are often managed in different locations, with content usually spread across other systems. For remote inspections to be successful, they need a single path to compliance; they need TMF management and storage centralization.

Documentation integrity through digitization

Put simply, an effective document management strategy will help ensure that your organization’s Trial Master File is accurate and complete. With a strong focus on the integrity of information, your organization can avoid documentation inconsistencies and missing content, while also avoiding breaches of confidentiality.

In building a well-designed plan, consider procedures for ensuring accuracy and completeness, implementing technical controls to detect unauthorized changes to records, and periodic audits to verify compliance with policies.

A robust document integrity management plan can (and should) include:

  • clear and concise policies around document handling and storage
  • regular auditing of systems and practices.
  • training for all employees on document handling procedures.
  • a focus on continuous improvement.

Regular auditing of systems and processes must be conducted to ensure information is accurate and reliable. In doing so, companies can identify weak points in their operations and take corrective action to contain issues. Additionally, regular auditing helps build trust with inspectors and sponsors, demonstrating a commitment to quality control.

Inspection readiness when you need it

The life sciences industry is complex and regulated. Kivo’s clinical document management solution helps ensure customer records are accurate and available to stakeholders.

Equipped with modern cloud architecture and Part 11 compliance, Kivo delivers virtual inspection preparedness in minutes. All core content, releases, and innovative solutions are tailored to the life sciences industry so organizations can easily manage documents throughout the submission lifecycle and beyond.

Download our white paper and discover how Kivo prepares you for a virtual TMF inspection and builds inspection readiness into your processes.



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