In regulated life sciences environments, documentation is more than a formality - it is proof. Whether demonstrating GMP compliance, validating a system, responding to a deviation, or defending decisions during an inspection, organizations must be able to show objective evidence that activities were performed correctly and at the appropriate time.
Regulators, auditors, and investigators consistently apply a simple standard: if an action is not documented, it effectively did not happen. Even when teams perform work properly, the absence of clear, contemporaneous records can result in findings, warning letters, or questions about the credibility of the quality system. Strong evidence trails are therefore essential to both compliance and defensibility.
This webinar focuses on the practical skills required to build documentation that stands up to scrutiny. Participants will learn what truly counts as evidence and how regulators distinguish between facts and assumptions. Verbal explanations, memory, or informal notes are rarely sufficient. Instead, credible evidence consists of objective, traceable, and time-stamped records that clearly show who performed an activity, what was done, when it occurred, and why decisions were made. Understanding this distinction helps organizations avoid the common mistake of relying on recollection or after-the-fact reconstruction.
A key theme of the session is contemporaneous documentation. Writing entries at the time work occurs ensures accuracy and reduces the risk of hindsight bias or incomplete information. Participants will explore principles such as ALCOA+ and learn how proper dating, signing, sequencing, and correction practices create trustworthy records. Real-time documentation not only satisfies regulatory expectations but also improves internal communication and consistency.
The webinar also addresses the full range of documentation sources that may serve as evidence, including logbooks, controlled forms, emails, and electronic systems. While many teams focus only on formal documents, inspectors frequently review audit trails, system logs, and communication records to verify events. Participants will learn how to manage both paper and electronic records to ensure traceability and integrity. Emphasis is placed on understanding audit trail expectations, such as tracking changes, user accountability, and maintaining secure, tamper-resistant systems.
Beyond recording actions, effective evidence trails also capture decision-making. Regulators often ask why a particular course of action was chosen or how risks were assessed. Without documented rationale, even appropriate decisions may appear arbitrary. By logging meeting outcomes, risk assessments, and approval logic, organizations create a clear narrative that demonstrates control and sound judgment.
By the end of the session, participants will understand how to design documentation practices that are simple, consistent, and defensible. Instead of scrambling to justify actions during an inspection, teams will have clear evidence ready - protecting both the organization and the individuals responsible for critical decisions.
Why should you Attend:
If you've ever struggled to answer an inspector's request to "show me the evidence," this webinar will give you the tools to be confident and prepared. You'll learn exactly what regulators consider credible proof, how to document activities and decisions in real time, how to use logbooks and electronic records effectively, and how to create clear audit trails that protect your team and your organization. By strengthening your evidence practices, you’ll reduce findings, avoid stressful reconstructions, and ensure your documentation consistently demonstrates control and compliance.
Areas Covered in the Session:
