Regulatory agencies such as the US FDA have long established validation as a core requirement of quality assurance for medical device manufacturers. Still, many companies fail to develop an adequate validation program, which can prove costly if discovered by an inspector. Over the last several years, inadequate validation has been one of the most common sources of US FDA Form 483 findings, so it is critical to address this requirement early. Responding to a FDA Form 483 from the US FDA is disruptive and expensive, but can be much more so if major changes are required to retroactively validate a process, system, piece of equipment or working environment.
Keys to a successful validation program
Validation is broadly applied across the organization to ensure that products, equipment, processes, software and systems operate as designed and intended. A successful validation program brings together engineering, manufacturing, regulatory compliance, and quality assurance to develop test solutions that are unique to each application. Developers of medical devices must validate the product design to ensure that it meets the user's requirements. Manufacturers of medical devices must validate any process, including any associated equipment and software, whose entire output is not or cannot be fully verified by inspection. Examples of these type of processes are sterilization, packaging systems, soldering processes, and automated systems. Critical processes that may require validation include material handling, assembly, chemical or biological processing, purification, testing, cleaning, packaging, labeling, storage and distribution.
Emergo is experienced in validation of many types of equipment, processes and systems used in a wide variety of medical device applications. We use a risk-based approach to validation that analyzes each process for potential harm and likelihood of occurrence in order to focus testing around the most critical functions. To properly evaluate these risks, our staff includes engineers and scientists who understand the technical functionality of the process. We work closely with each client to tailor validation projects to their exact needs.
Emergo can provide medical device validation consulting for:
- Medical device design validation and design transfer for manufacturing.
- Equipment commissioning and qualification (IQ/OQ/PQ).
- Facility and utilities qualification.
- Computer systems and medical device software validation.
- Automation / control system validation.
- Cleaning validation.
- Validation of chemical processing and purification processes.
- Medical device manufacturing and packaging validation.
- Validation training for employees.
- Laboratory equipment qualification.
- 21 CFR Part 11 gap assessments.
Please contact us for more information on medical device validation consulting services.