Meeting FDA Requirements?
We will be addressing documentation as it relates to medical devices, processes, and products. With our articles over the next couple of weeks, you will have an understanding of the right way to adhere to Good Documentation Practices (GDocP) for all things relating to life sciences products such as medical devices, automotive, and substances. You can access our detailed explanation on the subject by following this series. The device/products/substances covered will address consumption for LifeScience in general.
Some of the areas we will be covering include;
- Engineering (R&D)
- Storage and
With our guidance on the right techniques and tools, you should be able to create documents that are easy to understand, traceable, and consistent.
It is worth noting that the techniques shared in these series are a combination of existing guidelines, legislative regulations from governing organizations, and acceptable industry best practices.
What will you learn in these series?
- Know why Good documentation is crucial to FDA regulations or other bodies.
- The importance of GDocP and why you should understand it.
- Educate members of your team on the right and wrong things regarding documentation.
- Apply the knowledge to your daily operations.
- Gain confidence in your ability to produce high-quality documents.
Who should learn about GDocP?
Anyone or professional that is responsible for documentation as it pertains to medical products or testing in a manufacturing capacity.
Areas of focus
We will be focusing on Design Input/Output Requirements Test and Test results as part of GDocP in the following areas;
- All levels of Engineering Specifications
- Protocol Generation
- Legal Factors
- Costly Errors
- Protocol Execution
- Variable Data
- Units of Measurement
- Calculations or Formulas
- Rules of Thumbs
- Oops and Uh-Ohs
- Expected Results
- Redline the Changes
At the end of these series, it is our belief that you gain valuable skills in generating good documents for all your medical products, processes, and substances.