A Comprehensive, Integrated Quality Management Solution Based on Microsoft SharePoint
The NextDocs Quality Management System addresses the full range of Quality processes from CAPA to Complaints, all in an integrated, SharePoint-based environment.
The NextDocs Quality Management System is part of the NextDocs family of compliance solutions and is built on the NextDocs Compliance Platform. As a result, the system fully addresses all 21 CFR Part 11 and related regulatory requirements.
Built as a set of modular components, each quality process in the NextDocs solution is connected to the others. This level of integration, combined with Microsoft SharePoint’s familiar user interface and integration with Microsoft Office, allows users to quickly become proficient with the entire range of quality processes. The result is faster deployment, less training and higher adoption rates.
At the same time, technology professionals appreciate that the NextDocs Quality Management System is “Built in SharePoint” and out-of-the-box, which means that it sits comfortably within a standard SharePoint implementation and is ready to deploy. The result is less complexity, lower implementation costs and far lower costs of ownership than alternative quality management systems built on proprietary, legacy platforms.
Purpose-built for businesses in highly regulated environments.
By improving on Microsoft’s dynamic SharePoint platform, NextDocs web-based zero install software is cost-effective, intuitive, flexible and scalable.
Ensure compliance with the Current Good Manufacturing Practices (CGMP)
The NextDocs Quality Management Software helps detect nonconformities and identify their source. It is composed of a series of pre-defined documents and processes necessary in guaranteeing quality. The pre-defined documents ensure that the system demonstrates compliance. The processes ensure that corrective and preventive actions are initiated to address any product, material or component nonconformity. Each event type component includes a list item structure for the metadata common to the associated documents.
Core Quality Management Components
Audit Management (AM)
Designed for external and internal audits AM includes four content types: Audit Plan, Audit Checklist, Audit Notebook and Audit Report. AM feeds into Deviation Processing and thereby offers a self-healing solution for nonconformance and observations.
Deviation Processing
Designed for Nonconformance and for Observation registration. Once registered, the deviations feed the CAPA process.
Full CAPA Capabilities
Built for Corrective and Preventive Actions starting with deviation registration through root cause analysis and proposed corrective and preventive actions, to effectiveness measurement and ensured root cause elimination.
Trending Report Capabilities
Trending Reports, one of the most successful means of deviation detection, allow escalation as the trends develop, which facilitates timely correction.
Customer Complaint (CC)/Severe Adverse Event Management (SAE)
Includes MedWatch-reporting details and trending reports. CC and SAE fully integrate with Deviation Processing, CAPA and Change Control.
Equipment Management (EM)
Includes calibration, maintenance and verification tracking; certificate and contract monitoring. EM tracks the due date for all maintenance activities and reduces the risk of deviations by assuring equipment is maintained and is integrated with Deviation Processing, CAPA and Change Control.
Change Control
Designed to manage change for any feature or component and provides a formal, structured process to ensure stability, safety and continuity of quality.
