How does a unified QMS like Scilife's help address audit observations and ensure compliance across multi-site organizations?
A unified QMS like Scilife ensures consistent document control, complete training records, and automated CAPAs and Change Control process tracking. In Scilife, Quality metrics and guaranteed Audit Trails are tracked, making compliance transparent and reducing risk during inspections.
Also, if you have shared policies applicable to all sites, you can maintain and share just one policy across all locations. For site-specific SOPs, you can publish different versions for different sites and share only the ones applicable to each location. This allows you to harmonize your QMS while maintaining segmented documented information for every site. Scilife provides complete flexibility in this regard.
How do organizations save costs by harmonizing their QMS? Are there real-world examples or metrics?
By centralizing processes, Scilife eliminates redundant document efforts, reduces duplicate resources, and automates workflows. For example, one client has reduced duplication by around 40%, saving significant time and resources.
We have a return on investment calculator, and we recommend looking at your current processes and checking your documented information workflow and quality processes. Then, investigate the time spent on each activity and consider ways to improve them.
McKinsey has pointed out that you can save up to 40% of the time spent on quality processes. This doesn't highlight a need to reduce teams but allows them to dedicate more time to important tasks, such as improving your quality management system. With an eQMS like Scilife, you can reduce time spent on manual and redundant tasks and use it for important activities like improving your quality management system.
How does Scilife balance standardizing quality processes across sites while allowing location-specific customizations?
Scilife offers a module and flexible architecture that allows standardization for global profit processes while enabling customization for site-specific needs. For example, workflows can be tailored to local regulatory requirements while adhering to a unified global policy structure.
Is your software applicable to everyone?
Our software applies to the Life Sciences sector. If you are a company that needs to comply with good manufacturing practices, biotech regulations, or medical device regulations, you can use this software.
We have out-of-the-box workflows for managing CAPAs, Document Control, Investigations, Root Cause Analysis, Trainings, and many more processes. You can view our full range of features and capabilities at: https://www.scilife.io/
How is a unified QMS at a Manufacturing & R&D site maintained?
Within Scilife, the Groups feature helps with this task. For instance, you can have a GMP group to segment the information, where you keep all the policies, SOPs, and other documents. Then, you can have another group for your R&D processes, where you maintain all the standards and regulations you must comply with for that sector.
Which standards are at the base of your framework?
We comply with the following standards: GMP, GDP, GLP, GCP, GAMP5, FDA 21 CFR Part 11, EU Annex 11, ISO 13485, ISO 14971, ISO 15189, ISO 17025.
