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What is Qualitum?

Qualitum is a cutting-edge platform specifically crafted for computer system validation (CSV/CQV) within the regulated life sciences industry. It automates the generation of IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents like URS, P&IDs, and SOP libraries, ensuring thorough tracking of requirements through a queryable graph that replaces the need for traditional spreadsheet RTMs. The platform is committed to upholding stringent ALCOA+ data integrity standards by monitoring every record rather than just samples and enabling human reviewers to validate and approve the outputs generated by its agent. Qualitum functions on a single-tenant basis across AWS, Azure, or on-premises setups, providing customers with control over their keys and preventing any training rights on their data. Its ability to integrate smoothly with existing systems of record such as Veeva, MasterControl, TrackWise, and AVEVA PI makes it an adaptable option for various organizations. Tailored to meet the demands of Heads of Validation and validation consultancies, it supports stakeholders in the pharmaceutical, biotechnology, and medical device sectors. Prospective clients can request a per-site annual license quote, and there is also a fixed-fee pilot program available for 8-12 weeks for a single system, allowing for an introductory experience. This well-rounded approach ensures that companies can efficiently reach their validation objectives while remaining compliant in an increasingly regulated landscape, enhancing the overall effectiveness of their operations.

What is Amici?

MyAmici is an all-encompassing cloud-driven LabOps platform that merges procurement, inventory management, purchasing, and supply-chain functionalities tailored for laboratories in the biotech and life sciences sectors into a unified system. By integrating a laboratory's internal systems—like ERP, inventory databases, supplier catalogs, and invoicing applications—with external vendors and suppliers, it enables the real-time exchange of information, ensuring that laboratories maintain a reliable and consistent “single source of truth” for procurement, inventory status, consumption trends, invoices, and delivery notifications. This flawless integration ensures that any modifications in product listings, order placements, deliveries, and invoicing are automatically synchronized between vendor systems and the lab’s internal records, thereby removing the necessity for manual data entry and significantly reducing the risk of errors. MyAmici skillfully oversees the entire laboratory procurement workflow, which includes requisition processes, purchase orders, order tracking, receipt management, inventory oversight, and the management of both assets and consumables. Additionally, this platform significantly boosts operational efficiency, leading to more effective laboratory management and enhanced research productivity. Ultimately, by streamlining these processes, MyAmici empowers labs to focus on their core research activities, driving innovation in the life sciences field.

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Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Company Facts

Organization Name

Amici Procurement Solutions

Date Founded

2005

Company Location

United Kingdom

Company Website

www.amiciprocurement.com/biotech-lab-solutions/software-integration/

Categories and Features

Life Sciences

Not specified

Categories and Features

Life Sciences

Not specified

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