Documenting Investigations
World regulatory bodies state "If it's not written down, it didn't happen."
Too often in organizations, thorough investigations are performed. However, due to poor or a lack of documentation, individual investigators in organizations do not get credit for all of their hard work.
Our documentation solutions teach proven technical writing skills needed for compliant, effective and efficient quality system management. We provide the skills, tools and techniques necessary to ensure your entire document is well-aligned, from the investigation of the problem statement to the results of the effectiveness check on the implemented Corrective Action. Our solutions help you to provide a justification for conclusions drawn and a rationale for decisions made.
KEY BENEFITS
After working with us, our clients are able to:
- Understand what the FDA and world regulatory bodies expect
- Patterns for well-documented reports
- How to write for multiple audiences who will be reading the report
- Document design and control and the quality of technical writing
- Documentation alignment
- Explain regulatory requirements with respect to your organization
- Write clear, concise and objective reports
- Document a clear history of events and actions
- Write reports that will meet auditor expectations
PathWise focuses on a solution-based approach to solving client issues. When training in Documenting Investigations is the appropriate solution, we help simplify the necessary concepts and processes, ensuring a quality system program that conforms to industry and regulatory standards. Our instructors utilize a how-to approach to learning, using a blended application of classroom exercise and real-life experience.
Whether it is remediation resulting from regulatory findings, (Form 483 or Warning Letter) or the objective is to improve quality and compliance before that happens, PathWise will work with your organization to deliver solutions. Our consultants go beyond prescriptive suggestions- we work in tandem with clients to create new systems or write new procedures.
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