Jama Connect®, a product development platform, uniquely creates Living Requirements™. This digital thread is created through siloed, test, and risk activities to provide end to end compliance, risk mitigation, process improvement, and compliance. Companies creating complex products, systems, and software can now define, align, and execute on what they need. This reduces the time and effort required to prove compliance and saves on rework. You can be sure of success by choosing a solution that is easy-to-use, flexible, and offers support and services that are adoption-oriented.
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Polonious is an ISO27001 investigation management workflow solution designed around 3 key principles:
1 - Security
2 - Process centric
3 - Configuration and flexibility
What this means is that Polonious allows you to build workflows to manage your investigations in a way that manages your data and your evidence in a highly secure, ISO27001 certified way; allows you to comply with any regulatory requirements with minimal headache and effort by building workflows which are inherently compliant, and; does so without the need for expensive and time consuming code changes - it's even possible for users to do it themselves via the GUI.
With Polonious, you can run detailed reports on case outcomes, timeframes, and finances, and break that down across case types, investigators, and even down to investigation status. So you can prove your value up the chain, but you can also identify any problem areas and improve your efficiency.
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MediaLab Intelligent Quality Engine (IQE)
MediaLab's Intelligent Quality Engine (IQE) solution is designed to deliver powerful automation for laboratory non-conforming event management processes. IQE eliminates the need for paper-based, manual investigation and CAPA processes while reducing cost and supporting the quality improvement program. IQE helps your laboratory follow corrective and preventive action standards as outlined by CAP, joint commission, ISO, and other accrediting bodies. You'll benefit from a streamlined approach that supports your regulatory compliance. Start by using our online form templates, or create your own. Allow employees to create events as problems arise. MediaLab will route your event through each phase of the event management lifecycle, from initial event description to risk analysis, closure, and change effectiveness evaluations. Your current processes and forms work beautifully in IQE.
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MediaLab Document Control
Document Control is MediaLab’s document management system. Our online solution empowers lab directors and supervisors to manage their policies, procedures, forms, job aids, and worksheets using configurable review settings, custom approval workflows, automated employee sign-offs, and more! Reduce time spent chasing approval and review signatures while benefiting from email notifications and personalized to-do lists for employees.
MediaLab's Document Control supports:
• Digital records and version control of all documents,
• Standardization across all documents from all sites,
• Electronic signatures that meet 21 CFR Part 11 standards,
• Customized approval workflows and processes,
• Robust searching to easily locate specific documents, and more!
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