The webinar will focus on the importance of managing FDA oversight of computer system validation in the medical device industry by anticipating and preparing for trends. The type and extent of oversight varies with changes to the economic, political, and business environment. FDA funding, the length of government reach into the private sector, and the ability of companies to lobby the government for less regulation all play a role in terms of the dynamics at play between industry and the FDA.
Medical device companies must be vigilant in understanding the factors that impact their ability to operate with oversight from FDA as it relates to computer system validation. In all cases, companies should do the right thing and have robust computer system validation programs that are well executed and documented. However, there are some extremes in oversight that occasionally crop up and may cause expectations to go above and beyond what is considered reasonable. In such cases, companies must determine how much risk to take in terms of the strength of their programs, and how well they are able to negotiate with their FDA auditors.
Typically, a medical device company will develop a relationship with the FDA office that sends auditors to oversee computer system validation programs in their organization. Depending on upcoming trends, medical device companies may want to work harder to further strengthen these relationships and build greater trust with FDA to ensure that even as oversight becomes more overbearing, it will not cause the company to waste resources trying to meet expectations that may be unrealistic.
A good example of a recent trend is the focus on risk management in developing, executing and documenting a validation program and validation plans for specific systems at medical device companies. FDA has fewer resources to conduct audits and oversight of computer system validation, hence medical device companies have been expected to identify the risk associated with each computer system that “touches” a medical device product (through manufacturing, testing, distribution, etc.), and take the appropriate measures to mitigate that risk. The trend has been for FDA to ask questions relevant to risk and ascertain fairly early during an audit what lengths the medical device company has gone to in order to prove they have thoroughly validated their systems accordingly.
Effective and compliant computer system validation is critical to any medical device organization. With changes in the economic, political and business factors that influence the extent to which FDA exercises oversight, companies must actively anticipate what that means for their existing and planned computer system validation programs and plans.
It is vital for medical device companies to maintain a pulse on the regulatory environment in order to fortify system validation efforts, as necessary, to meet FDA expectations. Conversely, they must be vigilant to not allow looser regulations or oversight to influence the level of computer system validation they adopt as their standard practice. There is always danger that a medical device company will become too lax, and will either be caught off-guard, or used by FDA to make an example of why they need more resources and need to tighten those very regulations. All in all, it is the best practice to have a robust computer system validation, continue executing against it consistently, and documenting it thoroughly.
By maintaining a strong and consistent computer system validation program, medical device companies can further build trust with FDA and the consumers who rely on such oversight for protection.
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.
During her career, Carolyn worked directly, or as a consultant, for many top-tier pharmaceutical companies in the US and Europe. She was responsible for computer system validation across all GxP functions at a major pharmaceutical company. Carolyn developed validation programs and strategies back in the mid-1980s, when FDA guidelines were first issued. She was an industry reviewer for 21 CFR Part 11, the FDA's electronic record/electronic signature (ER/ES) regulation. She has taught ER/ES compliance, along with computer system validation and risk management/compliance at a number of Fortune 100 firms. Her experience includes work with FDA-regulated systems used in all areas of research, development, manufacturing, quality testing and distribution.
Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.