Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

Qualitum is an innovative platform designed for computer system validation (CSV/CQV) specifically tailored for the regulated life sciences sector. It automatically generates IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents such as URS, P&IDs, and SOP libraries, ensuring that each requirement is tracked comprehensively through a queryable graph that eliminates the need for traditional spreadsheet RTMs. The platform maintains strict adherence to ALCOA+ data integrity standards, monitoring every record instead of just samples, while allowing human reviewers to validate and approve the outputs produced by the agent. Qualitum operates on a single-tenant basis across AWS, Azure, or on-premises environments, empowering customers with control over their keys and prohibiting any training rights on customer data. It seamlessly integrates with existing systems of record, including Veeva, MasterControl, TrackWise, AVEVA PI, Tulip, and others, making it a versatile choice for organizations. Designed with the needs of Heads of Validation and validation consultancies in mind, it serves stakeholders in the pharmaceutical, biotechnology, and medical device industries. Interested parties can obtain a per-site annual license quote upon request, and a fixed-fee pilot program lasting 8-12 weeks is offered for a single system to facilitate an initial experience. This comprehensive approach ensures that organizations can achieve their validation goals efficiently while maintaining compliance in a highly regulated environment.

Description

A reliable platform designed for the development and sharing of reproducible methodologies. This centralized and secure environment allows for the organization of current and version-controlled methods, complete with a history feature and support for simultaneous editing. Users can create and discover reproducible experimental and computational protocols, enriched with videos, reagents, detailed parameters, and additional resources. The platform ensures private and secure collaboration while adhering to HIPAA regulations, featuring an audit trail, approval/signature processes compliant with 21 CFR Part 11, two-factor authentication, encryption, and Virtual Private Cloud (VPC) capabilities, among other security measures. By utilizing a protocols.io Institutional Plan, institutions can enhance productivity, streamline teaching efforts, foster improved collaboration and recordkeeping, and significantly accelerate research advancements across a variety of scientific fields. This innovative approach not only boosts efficiency but also promotes a culture of transparency and reproducibility in research.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

No images available

Screenshots View All

Integrations

Scispot No 

Integrations

Scispot Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
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 No 
Mac No 
Linux No 
Chromebook No 

Customer Support

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

Customer Support

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

Types of Training

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

Types of Training

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

Vendor Details

Company Name

Qualitum

Website

qualitum.ai

Vendor Details

Company Name

protocols.io

Founded

2012

Country

United States

Website

www.protocols.io

Alternatives

Amici Reviews

Amici

Amici Procurement Solutions

Alternatives

Constructor Research Reviews

Constructor Research

Constructor Tech
Merit for Life Science Reviews

Merit for Life Science

Merit Solutions