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features
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support

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Description

In the realm of pharmaceutical production, it is crucial to document activities on the shop floor in real-time to maintain quality standards and comply with regulations such as 21 CFR Part 11 and Good Manufacturing Practices (GMPs). Utilizing an automated system guarantees that batch records are free from errors and can be easily accessed, while also allowing for the tracking of batch manufacturing processes. Electronic Batch Record (EBR) software, such as CaliberBRM, replaces traditional paper-based systems, thereby mitigating associated risks and ensuring the integrity of data and product quality. In industries that are highly regulated, particularly in life sciences, the real-time recording of the 4Ms becomes a necessity as it streamlines business processes. Transitioning to digital batch production records can significantly reduce both time and effort. The EBR system provides comprehensive oversight of the 4Ms, enabling organizations to minimize inventory waste, optimize workforce allocation, manage instruments effectively, and shorten review cycles, all of which lead to decreased operational costs. Furthermore, Quality Review Management (QRM) emphasizes the importance of exception-based reviews to expedite batch releases, enhancing overall efficiency. By implementing these modern solutions, companies can create a more agile and responsive manufacturing environment.

Description

Quality is a never-ending journey, requiring a deliberate effort to maintain a competitive edge in today's business landscape. In critical sectors such as pharmaceuticals, the acceptance, regulatory approvals, and overall success heavily depend on maintaining high-quality standards. The pharmaceutical realm is characterized by rigorous regulations that add layers of complexity to the management of business operations. To effectively navigate this landscape, it is essential to continually assess and innovate internal processes. An integrated quality management system becomes vital in this context. GMPPro, developed by Motto Systems, serves as a comprehensive and reliable quality management solution tailored to address quality challenges at every phase of drug development. This sophisticated system not only covers the entire scope of production, quality control, quality assurance, and engineering but can also function as modular independent solutions. GMPPro is engineered to ensure complete oversight of processes and is supported by our dedicated team of industry professionals, ensuring that quality remains at the forefront of pharmaceutical development. By leveraging such advanced systems, companies can better position themselves for success in a highly regulated environment.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

CaliberPulse Yes 
CalibereLog Yes 

Integrations

CaliberPulse No 
CalibereLog No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Caliber Technologies

Founded

2001

Country

India

Website

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

Vendor Details

Company Name

Motto Systems

Founded

2013

Country

India

Website

www.mottosys.com/gmppro-suite.html

Product Features

Manufacturing

Accounting Integration No 
ERP No 
MES No 
MRP No 
Maintenance Management No 
Purchase Order Management No 
Quality Management Yes 
Quotes/Estimates No 
Reporting/Analytics Yes 
Safety Management No 
Shipping Management No 

Manufacturing Execution

Document Management No 
Forecasting No 
Quality Control Yes 
Quote Management No 
Resource Management No 
Supplier Management No 
Supply Chain Management No 
Traceability No 

Product Features

Compliance

Archiving & Retention Yes 
Artificial Intelligence (AI) No 
Audit Management Yes 
Compliance Tracking No 
Controls Testing Yes 
Environmental Compliance No 
FDA Compliance Yes 
HIPAA Compliance No 
ISO Compliance Yes 
Incident Management No 
OSHA Compliance No 
Risk Management Yes 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control Yes 
Workflow / Process Automation No 

Quality Management

Audit Management Yes 
Complaint Management Yes 
Compliance Management Yes 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking Yes 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management No 
Supplier Quality Control Yes 
Training Management Yes 

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