TECHNICAL WRITING: The Compliance Problem that Nobody Talks About.

There are no FDA regulations governing “Technical Writing” quality or clarity. 

An FDA-regulated manufacturer’s documentation is the only way it proves its compliance with applicable regulations; the way it communicates its activities to the agency. 

And in this context, poor writing equals poor communication. 

Inadequate writing skills are arguably behind many—perhaps even most—of the problems noted during inspections of pharma and medical device manufacturing facilities. The evidence? Many Warning Letters include such phrases as “failed to explain,” “lacked rationale,” “failed to justify rationale,” “lacked evidence,” “failure to establish,” “did not provide sufficient information” and similar statements. All of these, signal a problem with how companies are writing the outcome documents reviewed by FDA investigators during inspections. 

What constitutes a good document for the FDA’s purposes? First and foremost, it must contain the information necessary to demonstrate compliance with regulatory requirements. That information must be based on sound technical and scientific principles. If that information is not written clearly so that FDA Investigators will easily understand what is trying to be conveyed, it may not pass muster during an inspection. 

Fortunately, good document writing is both an art and a process, which can be learned. 

Compliance documents subject to FDA review during inspections could be CAPA reports, including supplier CAPA, investigations of product non-conformances, batch failures and complaints, design or manufacturing changes and service reports.  

Also pertinent are technical records, like quality or regulatory plans, design review documentation, design transfer reports, verification and validation reports, equipment qualification reports, risk management reports, human factors analyses, clinical study results and regulatory submissions. 

PPS recognizes that writing quality is a significant aspect for FDA-regulated manufacturers. With this in mind, PPS has developed a comprehensive training workshop that helps companies learn how to “write for compliance.” 

Learn the Essence of Good Technical Writing Skills at PPS Workshop on "Regulatory Response Writing" to be held on 21st 23rd 28th & 30th June 2022

Book your dates to Join our Experts Dr. Subhash Pande & Mr. Pravin Manker

(Source: https://compliancearchitects.com)