Can your KPI tool be used for deviations and CAPAs too?
Yes, our KPI solution covers various modules, offering an initial glimpse into overdue items, expired documents, training overviews, open events, and new CAPAs. Moreover, each module is tailored to specific needs, with AI integration enhancing our KPI functionality. For instance, regarding events, we not only provide insights into current overdue events but also utilize historical data to predict impending delays with remarkable accuracy. This predictive capability is invaluable for preempting potential issues.
Additionally, our tool boasts many different dashboards, presenting data on reported events, closures, ongoing activities, and average closure times—all in a chronological format. The interactive nature of our tables allows users to seamlessly drill down into specific data points for deeper analysis. In essence, it serves as a comprehensive tool for QA professionals to dissect past occurrences, identify areas for enhancement, and prioritize evaluations.
Furthermore, we offer benchmarking against industry standards, enabling users to compare their performance relative to peers. This feature facilitates informed decision-making and continuous improvement initiatives. Overall, our KPI tool is indispensable for conducting regular quality reviews, providing real-time access to critical information whenever it's needed.
Your platform is very complete. Is it validated?
Absolutely. Scilife has been thoroughly validated in accordance with GAMP5 and 21 CFR Part 11 standards. However, it's important to note that customer validation is also necessary. To streamline this process, we provide a comprehensive validation documentation package, containing all the necessary evidence. This package substantially reduces the initial validation effort, typically covering around 90 to 95% of the requirements.
How are versions of documents managed by the system when you are implementing a Change to a document?
When a document is already published (v1.0) and you have a Change Request that implies creating a new version of it, Scilife will automatically manage the different versions. It will put the document in the draft when the change is in implementation, and it will generate a v1.1 only available for the roles in that document. At the same time, it will maintain the current effective version v1.0 until the new version v2.0 is published. At that precise moment, Scilife will mark v1.0 as substituted and will no longer be distributed across the users.
What could be the consequences of not mitigating one or multiple of these citations from the FDA?
Failing to mitigate FDA citations can lead to serious consequences, including regulatory actions, product recalls, product liability lawsuits, delays in approvals, sales bans, criminal charges, increased inspections, and significant damage to a company's reputation.
Could the group functionality you showed be used in a global company to manage different sites?
Certainly! This is precisely how many of our global clients leverage Scilife. By defining different sites and assigning specific groups to each, they can maintain segregation of information. Anything that necessitates sharing across all sites can be managed through a global or overarching group. This setup allows them to either maintain independent QMS for each site or establish a unified, harmonized system while still facilitating seamless collaboration and sharing of resources.
