![]() ![]() Companies may spend time and money addressing those observations and citations, or conducting a recall, but still fail to repair the underlying architecture of their quality systems, putting them at risk of seeing the same problems later on down the line. Quality system failures can also lead to product defects that result in recalls. Disjointed quality systems can lead to problems that show up as Form 483 observations during FDA inspections, or even as citations in a warning letter. Regardless of how it comes about, this sort of quality system development can have serious consequences with the FDA and other global regulators. ![]() There are many reasons disjointed quality systems can develop within a company: knee-jerk reactions to regulator citations quality staff lacking training in design thinking use of consultants applying audit-response thinking mergers and acquisitions where companies combine existing policies haphazardly and problem-driven policy development focused more on completing a CAPA than how the system ultimately works together. The result? Quality systems comprising unrelated parts and processes that are confusing, often disconnected and that may not meet business needs and regulator expectations. Instead of proactively designing an architecture aligned to their unique business model and incorporating market-based legal and regulatory requirements, companies instead react to problems and crises by creating ad-hoc policies, procedures, forms and other documents with little thought to how these documents will interact with other policies, procedures and systems throughout corporate operations. Winchester built her home without a design - without a plan - too many pharmaceutical and medical device companies similarly cobble together their quality systems incrementally over the years. What does a poorly designed mansion in California have to do with medical product manufacturing quality standards? Much as Mrs. This lack of architectural forethought and careful design resulted in a structure that features oddities like doors and stairs going nowhere, windows that overlook other rooms and stairs with odd-sized riders. Sara Winchester did not use an architect to design the building, adding on rooms and wings in a haphazard fashion. mansion and now tourist attraction, once the residence of Sarah Winchester, the widow of William Wirt Winchester of Winchester Repeating Arms fame, is reputed to be haunted, a claim some experts attribute to the haphazard way in which it was built. Although companies of all sizes and experience levels struggle with this concept, it is not often talked about in industry circles. Still, many companies struggle to build strong, functional quality systems, instead creating various regulatory versions of the Winchester Mystery House. Well designed and executed quality systems are the foundation of compliance for the highly regulated pharmaceutical and medical device industries. Quality, Compliance, Regulatory & Operations’ Staffing.REMS (Risk Evaluation And Mitigation Strategies).Product Development / Submissions / Commercialization.Interactions With Department Of Justice And The Courts.Operational Efficiency/Compliance Effectiveness.Quality & Compliance Computer-Based Systems.Quality System & Compliance Turnarounds / Restructuring.
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