NextDocs         Corrective and Preventative Actions Management         Comprehensive Solution for Deviations and Nonconfo...
The NextDocs Difference         Compliance without Complexity         The NextDocs Compliance Platform includes a comprehe...
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Corrective and Preventative Actions - CAPA Factsheet

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The NextDocs Corrective and Preventative Actions
(CAPA) solution is a comprehensive, Microsoft
SharePoint-based solution that connects issues,
investigators, and resolutions in a closed-loop module.

Any incident can be quickly and easily captured, assigned to an investigator, and tracked through resolution. The result is faster resolutions, better information and more effective preventative actions.

The NextDocs CAPA solution includes electronic
signatures, defined workflows, a complete audit trail and a range of other features to address regulatory requirements. It can be seamlessly integrated with other NextDocs quality solutions, allowing all types of incidents to automatically trigger a CAPA.

It can also be implemented in a pre-configured manner or can be fully configured to achieve compatibility with current processes.

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Corrective and Preventative Actions - CAPA Factsheet

  1. 1. NextDocs Corrective and Preventative Actions Management Comprehensive Solution for Deviations and Nonconformance for Continuous Improvement in Quality and Processes The NextDocs Corrective and Preventative Actions (CAPA) solution is a comprehensive, Microsoft NextDocs Software Solutions SharePoint-based solution that connects issues, investigators, and resolutions in a closed-loop module. Quality Clinical Regulatory Corporate Any incident can be quickly and easily captured, assigned to an investigator, and tracked through resolution. The result is faster resolutions, better information and more Corrective and Preventive Actions effective preventative actions. Key Features: The NextDocs CAPA solution includes electronic • Fully configurable electronic forms signatures, defined workflows, a complete audit trail • Support for Electronic Signatures • Fully configurable workflows and a range of other features to address regulatory • 21 CFR Part 11 compliant signatures requirements. It can be seamlessly integrated with other • Automated notification NextDocs quality solutions, allowing all types of incidents • Dashboard functionality for high level view to automatically trigger a CAPA. NextDocs Compliance Platform It can also be implemented in a pre-configured manner or can be fully configured to achieve compatibility with Microsoft SharePoint current processes. Key Benefits  Track incidents and causes of Corrective and Preventative Actions  Decrease cycle time and the associated costs by increasing efficiencies  Utilize previous data entered into an incident form into your CAPA forms thus minimizing transcription errors and wasteful manual tasks  Fully configurable allowing for compatibility with current processes  Lowers risk of compliance issues and lost data  Automates the management of the entire CAPA lifecycle, from draft to closure Accredited by ANABMain Headquarters: 500 N. Gulph Road, Suite 240, King of Prussia, PA 19406 • Tel: 610.265.9474 • www.nextdocs.comEU Headquarters: Elisabethstrasse 91, 80797 Munich, Germany • Tel: +49.89.5908.1435
  2. 2. The NextDocs Difference Compliance without Complexity The NextDocs Compliance Platform includes a comprehensive set of features that addresses all ICH, FDA, EMEA, and MHLW regulatory requirements. It is built in and fully integrated with the Microsoft SharePoint Server framework. SharePoint’s familiar user interface and seamless integration with Microsoft Office applications provide an easy-to-use environment for users. NextDocs software solutions install directly into the Microsoft SharePoint environment, extending rather than replacing familiar document management processes. The result is faster deployment, higher adoption rates and far lower costs than alternatives based on legacy platforms. Quality Clinical Regulatory Corporate SOP & Training Records Clinical Portal Regulatory Promotional Materials Document CAPA Electronic Trial Management Contract Management Master File Deviations Secure Extranet Collaboration Complaints Audit management Change Control NextDocs Compliance Platform Content Transformation Content Lifecycle Management Intelligent Content Creation Content Compliance PDF Rendering Web-based Workflow designer Configurable Unique Document IDs Electronic and Digital Signatures Overlay Publishing Smart Document Wizard Automatic Inactivity Sign-out Watermark Change Control PDF Collaboration - Annotations/Mark-up Compliant Audit Trail Controlled Printing Version Management Auto Naming Support for 21 CFR Part 11 Microsoft SharePoint ■ Real-time Adobe PDF conversion triggered by document ■ Version tracking with major and minor versioning, version state change or workflow step history and previous version restoration ■ Controlled document management including configurable ■ Configurable document numbering application of watermarks & overlays ■ Metadata tagging automatically sets document properties ■ Full lifecycle management of the document from inception ■ Folder templates that allow all or part of a folder structure to obsolescence to be replaced ■ Flexible and powerful process automation tools for ■ Electronic/digital signatures that address all regulatory change management, document review, and approval requirements ■ Check In/Check Out controls to prevent documents from ■ Audit trails that provide a detailed log of every activity being overwritten performed in the system Accredited by ANABMain Headquarters: 500 N. Gulph Road, Suite 240, King of Prussia, PA 19406 • Tel: 610.265.9474 • www.nextdocs.comEU Headquarters: Elisabethstrasse 91, 80797 Munich, Germany • Tel: +49.89.5908.1435

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