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What is Nova-QMS?

Maintaining consistent product quality and effective quality management systems presents considerable obstacles in today's pharmaceutical manufacturing environment. Sectors subject to rigorous regulations, such as Pharmaceuticals, Biotechnology, and Life Sciences, are required to follow Good Manufacturing Practices (GMP) to meet legal requirements. However, simply meeting GMP standards is not sufficient; organizations must also demonstrate compliance through proper documentation. Utilizing paper-based forms, disconnected systems, or manual processes to manage, track, and document quality-related issues and their resolutions does not provide adequate solutions for creating cohesive and integrated quality management systems that meet industry expectations. As a result, it becomes imperative for organizations to adopt more sophisticated and automated solutions to bolster their quality assurance initiatives and facilitate smoother compliance processes, ultimately leading to improved operational efficiency and product safety.

What is Kalypso Accel for RIM?

Kalypso provides an economical option for life sciences companies aiming to adopt a Regulatory Information Management (RIM) system called Accel for RIM. This innovative platform supports a cohesive strategy for efficiently managing and overseeing product registrations, while also improving submission accuracy and handling global Unique Device Identification (UDI) details, which helps in optimizing product distribution. Furthermore, it integrates compliance and quality data from various enterprise systems into a single, reliable source for tracking product registrations, thus speeding up the regulatory submission process. By leveraging modern APIs, the system compiles product information along with essential regulatory documents and submission packages. Designed for quick implementation, it is based on a validated software framework that incorporates industry best practices and proven successful deployments. Companies that implement this solution can anticipate not only increased operational efficiency but also a notable decrease in the time required for regulatory activities. Additionally, this streamlined approach can significantly enhance organizational productivity and focus on strategic initiatives.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

ntint.com/product/nova-qms/

Company Facts

Organization Name

Kalypso

Date Founded

2004

Company Location

United States

Company Website

kalypso.com/industries/life-sciences/digital-regulatory-information-management/

Categories and Features

Life Sciences

Not specified

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Categories and Features

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