Computer System Validation Compliance Required by FDA
It isn’t just biotech and pharmaceutical industries who must comply with the US Food and Drug Administration’s computer system validation requirements. Almost every industry is affected by its dictates, with an eye for a roll-out which affects design, development, and implementation in the fields of drug sales, medical devices, biological health, animal health, organ donation, and tobacco.
Is Your Company Compliant with the FDA’s Guidelines for Data Security?
While some of the FDA’s requirements can be automated, many more must be fine-tuned. These requirements can affect everything from your company’s phone system, communications, and even Cloud storage.
Planning, verification, testing, traceability, configuration management, and many other aspects of good software engineering as it relates to the FDA’s guidelines will be communicated in this lecture.
The FDA’s guidelines regarding computer system validation focus on avoiding adverse events, however, learning how to adhere to these guidelines can expose weaknesses in your company’s computer systems which might not otherwise be noticed. These can range from weaknesses which can cause data breaches, understanding who can legally “steward” data while it is being transferred and processed from a sales force to a team of doctors.
If you are among your company’s information technology analysts, an automation analyst, a technology developer, a lab manager or even a computer systems specialist, then this seminar is for you. Managers and software or hardware vendors will also benefit to understand federal requirements.
Join our November 5, 1:00 PM (EST) symposium led by Carolyn Troiano who has over 30 years of experience helping validate computer systems for compliance within the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She helped the FDA develop a guidebook on this very subject in the 1980s.
Her knowledge reaches into the present trends, to discuss issues such as the impact of the FDA’s compliance requests on medical devices, affecting their pathway to market, as well as quality and compliance issues that can pop up anywhere in a medical device’s lifecycle. This will affect:
- Medical device design control
- Pharmaceutical industry information storage and sharing
- The prevention of cyber hacking
- Risk management across industry
But the Pharmaceutical industry is just one affected by the FDA’s computer systems validation demands. Critical aspects will be scrutinized more than ever due to the overwhelming number of sensitive data breeches of late.
Ponemon’s Institute conducted a wide-ranging study to find that the global average cost of a data breach is up 6.4 percent over the previous year to $3.86 million.
The FDA’s own system was the target of a an “unauthorized access” security breach not long ago, likely spurring the government to crack down on cyber security in general. Though they have been targeted themselves, the FDA can instigate serious compliance investigations to companies suspected of having faulty data security.
During this symposium you will learn:
- The many components of computer system validation compliance required by the FDA
- The highly critical aspects of computer systems most likely to be scrutinized by the FDA during an audit
- Ways to anticipate and prepare for FDA scrutiny
- Methods to identify and select the best course of action to take when responding to an FDA finding, warning or consent decree
- Describe some of the key factors that influence the degree of the FDA’s enforcement for computer system validation programs in GxP regulated industries
- Ways to apply basic computer system validation principles to ensure that in all cases a regulated company is prepared for emerging trends
- Understand examples of enforcement actions by the FDA in your specific industry, and learn how companies have responded to identify your own best practices
If you will not able to attend the webinar in person, you can also order a transcript of the event here.