In the past 15 years, Novatek’s technical writing team has worked side by side with Peggy Ley, former technical writer, customer service support specialist and trainer for Ortho Clinical Diagnostics (OCD). Novatek provides outsourced technical writing services and training to help OCD launch medical device products, as well as documentation support for existing products. Last week, we introduced our three-part blog series inspired by Peggy’s unique perspective and lessons learned from her experiences at OCD.
Documentation is important to any industry for maintaining procedural consistency. It is especially important in highly regulated industries that are monitored closely, such as manufacturing and medical devices fields.
In a recent interview with Peggy Ley, a former senior technical writer at Ortho Clinical Diagnostics (OCD), Peggy shared her thoughts on the best practices for creating technical documentation and training in regulated industries. Peggy’s perspective is valuable because, along with technical writing, she has a background in medical lab work and customer service. These combined skills and experiences give her unique insights into both sides of the documentation processes in regulated environments – as a customer and a trainer.
Here are some ways to ensure you're providing a clear and accessible knowledge bank and audit-ready documentation.
Tips for Technical Documentation and Training in Manufacturing and Medical Device Industries
- Be clear and keep it simple.
- Make content easy to understand and easy to find.
- Know the FDA regulations and use the FDA audit process as your guide.
- Understand the customer’s environment.
- Training and documentation go hand in hand. Use documentation (product guides and package inserts) in the training process.
- Structure and consistency are important to developing comprehensive documentation. Use pre-approved templates to ensure that the documentation adheres to regulations and standards.
- Hire for medical device industry experience (even when outsourcing).
- Utilize Standard Operating Procedures (SOPs) and mentors as key resources.
Customers can’t afford downtime. Downtime impacts workflow, creates backlog of work and costs companies lots of money. In the pharmaceutical industry, downtime can delay time to market and cost companies a drug patent. Even when a new equipment purchase can improve their workflow, accuracy and throughput, the time to get up to speed can be disruptive.
Training and documentation can cut down on downtime. With the proper training and documentation, customers can learn the new equipment faster and reduce errors. When service technicians are trained and have troubleshooting guides, they can resolve the problem on the first visit. When customers are trained on unplanned downtime procedures, they can keep operations running smoothly and information complete and intact.
As a manufacturer, training and documentation impact your ability to sell and service a medical device product.
Beyond the customer experience, improper documentation exposes a company to liability and FDA regulatory audit. These tips, along with our more comprehensive guide, can help ensure a rigorous, accurate, and audit ready documentation.
As Peggy emphasized, in a regulated industry, "even writing is regulated.”
Is your process documentation audit ready? Download our checklist to find out:
Novatek’s new Process Protection service can help your company meet FDA compliance requirements faster. Contact us to learn how.
See our other posts in this series: