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Quality Management System (QMS)

After considering in-house development and several packaged solutions, Telerx chose NextDocs regulatory document and quality management software. NextDocs came highly recommended and I was familiar with it as a best-of-breed product with a proven track record of meeting our industry's requirements.

Barry Peters, VP of Corporate Quality and Compliance,Telerx

Quality Management System (QMS)

In recent years organizations in highly regulated industries have been under pressure to improve their quality processes. The ICH, FDA and other regulatory authorities have re-established their positions on quality management software systems to stress the importance of product quality monitoring, corrective and preventative action (CAPA), change control, and management review of quality performance.

Many companies are poorly equipped to meet these challenges due to a lack of truly closed-loop process models and an inability to collaborate and pass information between and among the full set of stakeholders including corporate management, quality assurance, and employees responsible for any quality-related job function.

NextDocs Quality Management Software

A Collaborative Quality Management Software System That Provides Transparency and Insight Across the Enterprise.

The NextDocs Quality Management Software System provides a collaborative, web-based approach to effectively connect people, tasks and processes for life sciences and manufacturing organizations. The result is increased effectiveness, efficient evaluation of performance, improve quality processes as well as enhanced compliance with ISO and GxP regulations.

The NextDocs quality management system (QMS) is a suite of integrated quality management software solutions in an easy-to-use collaborative platform. Because this suite is a complete and comprehensive solution based on Microsoft SharePoint, the total cost of ownership (TCO) for organizations is also greatly reduced.

Our pre-configured solutions for managing deviations, CAPAs, complaints, audit findings and change control addresses these key challenges to deliver a compliant, user-friendly solution while minimizing the demands on your already overtaxed business and IT Users.

Clients may choose to implement the platform in a phased approach, starting with only one or two modules, or may choose to take advantage of the entire suite.

The components of our Quality Management Software System include:

SOP Management
The NextDocs SOP Management Software addressed key challenges to deliver a compliant, user-friendly solution to manage Standard Operating Procedures and associated employee training records while minimizing the demands on your already overtaxed business and IT users.

Learn more about : SOP Management
CAPA Management
The NextDocs CAPA solution allows organizations to automatically trigger CAPAs from incidents of other quality processes or to independently create them on their own. NextDocs can manage the tracking, investigating, reviewing, approval, and closure of CAPA processes and prudently follow up with an effectiveness check for verification.

Learn more about : CAPA Management
Deviations Management
The NextDocs Deviation and OOS solution manages Deviations and OOS from draft, to review, to approval, to closure. Furthermore the NextDocs Deviation and OOS solution allows for the automatic creation of a CAPA if necessary to remedy the deviation with full traceability.

Learn more about : Deviations Management
Complaints Management
The NextDocs Complaints Management solution manages the recording, routing, and resolution of all customer complaints. By managing the recording of details when the complaint is initially reported, to the discovery of the root cause of the complaint, to any CAPA that may be necessary to remedy the root cause, the NextDocs system does it all.

Learn more about : Complaints Management
Audit Management
The NextDocs Audit Management Software System provides complete tracking of observations, findings, and recommendations. In addition action plans can be created using the recommendations found in an audit. With fully configurable forms and workflows, the NextDocs Audit Management solution can benefit any organization in an effective manner with an easy to use interface.

Learn more about : Audit Management