Workplace stress is not uncommon, especially for those who work in a heavily regulated industry, such as medical device manufacturing, where FDA compliance deadlines loom.Read More
The Novatek Blog
Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.
Developing and using technical documentation and standard processes is a way of life for FDA-regulated companies. The Code of Federal Regulations (Title 21, CFR Part 820) states repeatedly that the medical device manufacturers must “establish and maintain” procedures. To do so, regulated manufacturers should define, document, and implement process documentation. After implementation, it is critical to then follow up, review, and revise these technical pieces as needed.
What is scope creep?
All technical writing projects for a new product have a defined set of deliverables and a delivery date to support the success of the product launch. The steps and tasks needed to meet the deliverable expectations are considered the project scope. Professional technical writers build detailed project schedules to ensure that the entire scope of activities is completed by the delivery date. However, any variation in the project scope can affect the delivery date and, ultimately, the success of the product launch.
Scope creep (also called requirement creep and feature creep) is the term used to refer to any change in a project's original purpose, timeline, and budget after the project work has started. The bane of project managers and project teams, scope creep can sabotage a technical writing project—unless it is identified and controlled by the project manager.Read More
For companies in regulated industries, effective Standard Operating Procedures (SOPs) are important to the ability to manage quality control and process protection. Below we share best practices and tips for developing and managing an SOP process that can help companies meet the challenges that come with regulation standards.
Many businesses develop Standard Operating Procedures (SOPs) to ensure consistency in their processes, improve product quality, and prevent health and safety issues. An SOP is a written set of step-by-step instructions on how employees should complete a specific task or process. Its purpose is to ensure the successful outcome of the activity each time it is completed. For example, medical device manufacturers establish SOPs to make sure that employees comply with FDA regulations and follow quality management best practices.
A key to keeping up with fast-paced and ever-changing industries is monitoring trends year over year and staying up to date with the leaders of those markets. Novatek's State of Knowledge survey and report helps manufacturers gain insight and share their business perspectives on the coming year.Read More
For years, the move to online training has been a developing trend for most companies with a growing workforce. While advancements in technology and changing landscapes have made digital training common, establishing a useful online program can be challenging.Read More
The #1 reason manufacturers call Novatek after a technical manual is written internally is because it is not user-friendly. As a result, customers regularly complain about the lack of, or difficulty of, the technical manual and customer technical support experiences high call volume. Sales representatives grumble about how much time they're spending educating and troubleshooting versus selling new products. When contracts end or competing equipment or devices become available on the market, customers are quick to leave with no sense of loyalty.Read More
Holiday season has begun, and for many that means the busiest month of the year is about to begin. December not only brings year-end documentation projects to finish, but we also have holiday commitments to family and friends that need to be scheduled and planned. Then there are those never-ending ads bombarding us with messages to shop and buy, buy, buy. And we can't forget about the inevitable unexpected pop-ups that get added to our schedules.Read More
As 2017 nears, manufacturers are busy determining next year’s priority products and programs, budgeting projects, and determining resource needs for the upcoming year. When it comes to planning for product instructions, technical manuals, and training, most Product Managers take a guess at the hours, budget, and talent required.Read More