Quality Management, Document Control and Training

A Unified Suite for Quality Management,
Document Control, and Training

Modern, easy-to-use, suite of cloud applications that increase visibility and collaboration across stakeholders, allowing you to bring better quality products to market faster while maintaining compliance.

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QualityOne - Quality Management Software

Move beyond fragmented and hard-to-use document control, training and quality management software systems that leave you feeling frustrated and uncertain. QualityOne is the complete, easy-to-use document control, training, and quality management software suite.

With QualityOne, you can manage quality processes, document control, and role-based curriculum training management in a unified QMS software suite for employees, suppliers, contract manufacturers, and auditors.

Document Control
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DOCUMENT CONTROL

QualityOne Document Control solution enables employees and partners to author, collaboratively review, approve, and release documents. An efficient document control process is an essential part of compliance requirements in regulated industries subject to GxP and ISO standards. QualityOne document control allows users to easily and securely access the most current version of any document and automatically collects audit trail information. Seamless integration with Microsoft Office Online allows for real-time collaborative authoring, reducing review cycles and implementing changes faster.

Training Managament

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TRAINING MANAGEMENT

QualityOne Training Management enables employees to complete training and maintain training records to meet regulatory and internal requirements. Seamlessly manage and assign sophisticated training matrices using flexible, role-based alignment of users and content. Learners can easily view upcoming or complete training tasks with an intuitive user experience. Demonstrating compliance is easy with centralized training records and configurable reports that help ensure you're always audit-ready.

Nonconformance and Investigation

NONCONFORMANCE AND INVESTIGATION

QualityOne enables more effective management of nonconformance and investigation. Easily execute an investigation and root cause analysis to stay on top of quality and compliance requirements. Nonconformance may include departures from standard practices or specifications that result in non-conforming material or processes. 

Hundreds of customers from emerging companies to Fortune Global 500 trust Veeva to manage their most important processes, documents, and data.

"Veeva gives us a modern online quality management software system to achieve greater efficiency while maintaining compliance. With Veeva QualityOne QMS software, users log-in to one cloud-based system, regardless of location, to review content, make changes, or do approvals. Processes that used to take weeks can now be done in a matter of days."

Trevor Carroll I Quality Assurance Manager, New Chapter

CAPA Management
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CAPA MANAGEMENT

QualityOne CAPA management empowers your organization to effectively and efficiently manage and resolve nonconformances. Regardless of where issues arise, our complete quality management software solution allows for seamless linkages to quality processes such as customer complaints, audits, and change control, which saves time and reduces risk. Issues can be quickly contained and thoroughly investigated through a robust CAPA management solution that supports your process. Implementation of planned actions based on the root cause analysis can be assigned, tracked to completion, and checked for effectiveness - all in one system. Additionally, real-time dashboards allow for management oversight of the process and facilitate early detection to address systemic issues. Using this comprehensive CAPA management solution, your team can more effectively prevent recurrence of nonconformances.

Complaint Management

COMPLAINT MANAGEMENT

QualityOne complaint management enables organizations to quickly
and accurately process complaints coming from their most valuable assets - customers. Through this complete quality management software, complaints can be linked to product data and related QMS processes, like CAPA or SCAR, ensuring comprehensive issue resolution and completion of corrective actions. Real-time dashboards enable immediate identification of trends that facilitate prompt response to emerging customer and product issues, allowing your organization to stay ahead.

Supplier Quality Management

SUPPLIER QUALITY MANAGEMENT

QualityOne Supplier Quality Management (SQM) can transform your supplier relationships into partnerships dedicated to improving quality, ensuring ongoing compliance, and reducing risk. QualityOne QMS software facilitates this shift by enabling all parties, internal or external, to work together through supplier certifications, audits, corrective actions, and performance monitoring on the same application. Accessing the same data increases supplier accountability and improves collaboration and speed.

Audit Management

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AUDIT MANAGEMENT

QualityOne QMS software provides best practice end-to-end Audit Management, connecting all internal and external parties in one complete application. Originating at audit planning and scheduling, track and manage across the full continuum of the audit process. Maintain and utilize all supporting audit materials and checklists within the application. Upon completion of the audit, manage issuance of audit findings and corrective actions completion through the seamless linkage to the CAPA process.  QualityOne QMS software also provides secure and limited access to suppliers and other partners, enabling them to respond directly to audit findings and reducing manual and redundant efforts.

Change Control

CHANGE CONTROL

QualityOne Change Control effectively manages all product and process changes. Capture change requests from across the business and engage the right subject matter experts in the impact assessment all in one place. QualityOne users can assign actions, link them to required documents, and track them to completion, ensuring an effective process. Customized dashboards pull from document status and planned actions to instantly show the status of any or all change controls.

Risk Management

RISK MANAGEMENT

QualityOne Risk Management allows your organization to manage enterprise and operational risks to remain compliant with the most up-to-date requirements for risk-based decision making. Using risk registers and risk matrices, list and assess potential risk events or opportunities, evaluate severity and probability, prioritize mitigation activities, and track to completion. Stay ahead of potential issues and minimize compliance risk throughout your organization.

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