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Description
Ensuring uniform product quality and robust quality management procedures poses significant challenges in the current landscape of pharmaceutical manufacturing. Industries governed by strict regulations, including Pharmaceuticals, Biotechnology, and Life Sciences, must adhere to Good Manufacturing Practices (GMP) to comply with legal standards. Beyond merely fulfilling GMP obligations, it is essential to provide evidence of compliance. Relying on paper forms, isolated systems, or manual procedures to oversee, monitor, and document quality issues and responses fails to offer effective solutions for establishing cohesive and integrated quality management practices that align with industry standards. Consequently, organizations must seek more advanced and automated systems to enhance their quality assurance efforts and streamline compliance.
Description
OpenText™ Information Management solutions empower organizations in the life sciences sector to harness data and content insights, enhancing their decision-making and speeding up product development. These tools enable seamless integration, management, and secure sharing of information among individuals, systems, and devices. By utilizing information assets effectively from research and development through to commercialization, organizations can benefit from adaptable cloud-native software that operates in any environment. OpenText for life sciences significantly accelerates the discovery process, facilitating the extraction of actionable insights that foster innovation in the pipeline. Users can convert research papers into electronic lab notebooks through intelligent capture, and uncover valuable insights using text mining techniques. Moreover, the platform allows for the extraction of knowledge hidden within unstructured text of clinical trial reports, study protocols, and findings related to clinical safety and efficiency. It also offers methods to intelligently analyze, categorize, and extract information from clinical trial documents, ultimately minimizing the risk of expensive delays and interruptions in the development process. By effectively utilizing these advanced capabilities, life sciences organizations can significantly enhance their operational efficiency and drive forward their research initiatives.
API Access
Has API
API Access
Has API
Integrations
Amazon Web Services (AWS)
Google Cloud Platform
Microsoft 365
Oracle Cloud Infrastructure
SAP Cloud Platform
SAP HANA
SAP S/4HANA
Salesforce
Integrations
Amazon Web Services (AWS)
Google Cloud Platform
Microsoft 365
Oracle Cloud Infrastructure
SAP Cloud Platform
SAP HANA
SAP S/4HANA
Salesforce
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Novatek International
Founded
1996
Country
Canada
Website
ntint.com/product/nova-qms/
Vendor Details
Company Name
OpenText
Country
Canada
Website
www.opentext.com/products-and-solutions/industries/life-sciences
Product Features
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management