SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry.
This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others.
The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience.
SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
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AdaptiveGRC
Working with companies from regulated industries, we've realized that many find carrying out GRC tasks time-consuming and ineffective.
That's why we created AdaptiveGRC, a comprehensive solution designed to coordinate governance, risk, and compliance fully. The difference between success and failure is the ability to measure, monitor, and manage your GRC activities rapidly and efficiently.
The tool reduces the manual work and allows you to focus on things that really matter.
Each AdaptiveGRC module can be used as an individual and discrete solution or deployed as part of a fully integrated GRC framework. Whether you use a single module, multiple modules or the full solution suite, your organization will benefit from the operational efficiencies and instant management reports.
Struggling to figure out spreadsheets and automation? Our experts are here to help. Let's set up a call and explore the possibilities of streamlining GRC together.
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Total Lean Management (TLM) Software
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals.
TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types.
Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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SafetyCulture
SafetyCulture (formerly iAuditor) is used to conduct over 2 million inspections per month across all industries for safety, quality control, and operations.
It is used by over 25,000 businesses worldwide to complete more than 600M checks per year to improve safety and quality in their workplaces.
All of the inspection data is captured in real-time allowing you to instantly identify missed inspections and failed items and rapidly mitigate risks.
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