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In July, CDER announced that it would be conducting inspections focused on 21 CFR Part 11 (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm204012.htm) and that “[t]he Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.”
Software in the life science industry has not been this close to the regulatory center stage since 2003. Consequently, it is time to revisit your life science company’s management of software to assess and remediate potential risks.
3 Tips for Assessing and Reducing Life Science Software Risks:
Tip #1: Review- For many companies the priority of day-to-day management of software has slipped in recent years. Consequently, documentation and practices around software may be stale. Whether your company uses software to manage critical functions subject to regulatory oversight (e.g. clinical trials, adverse event reporting, or regulated product inventory) or software is a component of your regulated product (e.g. medical device or diagnostic), your company should review within an appropriate regulatory framework the condition, relevance and currency of documentation, policies, and processes around software. Some questions to ask in this process might include “Has the software been upgraded or technology changed since the last revision of the documentation?”, “Have we lost personnel whose expertise and knowledge over the years were important for the management, implementation, training, configuration or development of the software?”, and “Have we historically adopted tactically convenient methods in either our validation, training or development efforts that might not stand up to the emerging regulatory climate?”.
Tip #2: Renewal- Your review process should result in a gap analysis and a risk based remediation plan. But it cannot be just any remediation plan. Every life science business has nuances of its own. Products, resources, internal skills, corporate and marketing strategies, applicable regulations and position in the commercialization food chain are some factors that create a unique identity for each life science company. How you revitalize your software documentation and management practices should blend your business, IT, regulatory and quality management expertise into your plan. In short, make your implementation regulatively germane but pragmatically sustainable for your business.
Tip #3: Refocus- Reliance on technologies, either for operationalzing your business (as in the case of software applications) or as a core asset of your business (as in the case of commercialized products that include software or is software), tends to monopolize employee attention. Changes in how a company interacts with software systems likewise tend to monopolize employee attention. Whether that attention is positively or negatively focused will determine the successful implementation of your remediation plan. Your success drivers will include communications that effectively teach how regulatory compliance contributes to corporate long term success and how the chosen pragmatic approach lessens challenges introduced by change. Most critically, strong executive leadership and support will result in the right attitudes and results.
Software in the life science industry has not been this close to the regulatory center stage since 2003. Consequently, it is time to revisit your life science company’s management of software to assess and remediate potential risks.
3 Tips for Assessing and Reducing Life Science Software Risks:
Tip #1: Review- For many companies the priority of day-to-day management of software has slipped in recent years. Consequently, documentation and practices around software may be stale. Whether your company uses software to manage critical functions subject to regulatory oversight (e.g. clinical trials, adverse event reporting, or regulated product inventory) or software is a component of your regulated product (e.g. medical device or diagnostic), your company should review within an appropriate regulatory framework the condition, relevance and currency of documentation, policies, and processes around software. Some questions to ask in this process might include “Has the software been upgraded or technology changed since the last revision of the documentation?”, “Have we lost personnel whose expertise and knowledge over the years were important for the management, implementation, training, configuration or development of the software?”, and “Have we historically adopted tactically convenient methods in either our validation, training or development efforts that might not stand up to the emerging regulatory climate?”.
Tip #2: Renewal- Your review process should result in a gap analysis and a risk based remediation plan. But it cannot be just any remediation plan. Every life science business has nuances of its own. Products, resources, internal skills, corporate and marketing strategies, applicable regulations and position in the commercialization food chain are some factors that create a unique identity for each life science company. How you revitalize your software documentation and management practices should blend your business, IT, regulatory and quality management expertise into your plan. In short, make your implementation regulatively germane but pragmatically sustainable for your business.
Tip #3: Refocus- Reliance on technologies, either for operationalzing your business (as in the case of software applications) or as a core asset of your business (as in the case of commercialized products that include software or is software), tends to monopolize employee attention. Changes in how a company interacts with software systems likewise tend to monopolize employee attention. Whether that attention is positively or negatively focused will determine the successful implementation of your remediation plan. Your success drivers will include communications that effectively teach how regulatory compliance contributes to corporate long term success and how the chosen pragmatic approach lessens challenges introduced by change. Most critically, strong executive leadership and support will result in the right attitudes and results.
