QVscribe
QRA’s innovative tools enhance the generation, assessment, and forecasting of engineering artifacts, enabling engineers to shift their focus from monotonous tasks to vital path development.
Our offerings automate the generation of safe project artifacts designed for high-stakes engineering environments.
Engineers frequently find themselves bogged down by the repetitive process of refining requirements, with the quality of these metrics differing significantly across various sectors. QVscribe, the flagship product of QRA, addresses this issue by automatically aggregating these metrics and integrating them into project documentation, thereby identifying potential risks, errors, and ambiguities. This streamlined process allows engineers to concentrate on more intricate challenges at hand.
To make requirement authoring even easier, QRA has unveiled an innovative five-point scoring system that boosts engineers' confidence in their work. A perfect score indicates that the structure and phrasing are spot on, while lower scores provide actionable feedback for improvement. This functionality not only enhances the current requirements but also minimizes common mistakes and fosters the development of better authoring skills as time progresses. Furthermore, by leveraging these tools, teams can expect to see increased efficiency and improved project outcomes.
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isoTracker Quality Management
isoTracker Quality Management is a widely recognized cloud-based quality management software (QMS) that serves organizations globally in overseeing their compliance with various ISO standards such as ISO 9001, ISO 13485, ISO 22000, ISO 17025, and ISO 14001, among others. This versatile solution is designed as a modular platform, allowing businesses to tailor it according to their unique needs while maintaining a competitive pricing structure and providing exceptional customer support. Organizations can choose from a variety of modules, including Document Control, Complaints, CAPA, Audits, Training, Non-Conformance, and Risk, to create a customized quality management system that addresses all aspects of their operations effectively. By utilizing isoTracker, companies can enhance their quality management processes and ensure ongoing compliance with industry standards.
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SimplerQMS
SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector.
This innovative platform ensures adherence to an array of regulatory standards, 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, and ICH Q10, among others, and is fully validated under GAMP5 guidelines.
The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities.
Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel.
In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.
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SBS Quality Management Software Suite
The SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency:
SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance.
SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features.
SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management.
SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations.
Lastly, SBS Vendor Management maintains an approved vendor list, formulates vendor qualification plans, and tracks the qualification history of suppliers.
Each of these modules can be acquired individually or in various combinations to meet diverse business needs.
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