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What is Nova-Cleaning Validation?

Nova-Cleaning Validation software is essential for enhancing product integrity by adeptly handling changes and assessing the risks related to cross-contamination and impurities in a dynamic production environment. It diligently examines every modification concerning methods, APIs, products, equipment, and family groups to maintain product integrity while ensuring compliance with regulatory requirements. In addition, Nova-Cleaning Validation complies with the stipulations outlined in 21 CFR Part 11 and EU Annex 11, which further solidifies its reliability. The system utilizes a risk-based approach and is thoroughly designed in accordance with PDA Technical Reports 29 and 49, ISPE MaPP, and 21 CFR Part 211.67, positioning it as a trusted option for quality assurance in the pharmaceutical sector. This all-encompassing strategy not only protects product quality but also boosts the overall efficiency of the manufacturing process, ultimately leading to more reliable outcomes for stakeholders. By continuously adapting to new challenges in the industry, it ensures that the highest standards of quality are consistently met.

What is CaliberBRM?

In the field of pharmaceutical manufacturing, it is essential to accurately capture activities on the production floor in real time to uphold quality standards and adhere to regulations such as 21 CFR Part 11 and Good Manufacturing Practices (GMPs). The use of an automated system ensures that batch records are devoid of errors and can be readily accessed, facilitating the monitoring of batch manufacturing procedures. Electronic Batch Record (EBR) systems, like CaliberBRM, supplant conventional paper documentation, thereby reducing risks and safeguarding data integrity and product quality. In highly regulated sectors, particularly within life sciences, the necessity of recording the 4Ms in real time becomes evident as it enhances business processes. The shift to digital batch production records can greatly diminish both time and effort. The EBR system offers thorough oversight of the 4Ms, which helps organizations to cut down on inventory waste, improve workforce management, efficiently handle instruments, and accelerate review cycles, ultimately resulting in lower operational costs. Additionally, Quality Review Management (QRM) highlights the significance of exception-based reviews, which not only expedite batch releases but also boost overall productivity. By adopting these innovative solutions, businesses can cultivate a more flexible and responsive manufacturing landscape, fostering continuous improvement and adaptability in their operations.

Media

Media

Integrations Supported

Integrations Supported

CaliberPulse
CalibereLog

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

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

www.ntint.com

Company Facts

Organization Name

Caliber Technologies

Date Founded

2001

Company Location

India

Company Website

caliberuniversal.com/solutions/batch-record-management/

Categories and Features

Manufacturing

Quality Management
Reporting/Analytics

Categories and Features

Manufacturing

Quality Management
Reporting/Analytics

Manufacturing Execution

Quality Control

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