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What is Validfor?

Validfor is a powerful and secure digital validation solution that brings all aspects of the validation process into one cohesive, paperless system, designed specifically for industries with stringent regulations. This platform effectively simplifies validation responsibilities while ensuring compliance with essential standards such as GAMP 5, 21 CFR Part 11, and EU Annex 11. By supporting electronic records and sophisticated electronic signatures, Validfor delivers complete audit trails and tailored workflows for different roles, including Author, Reviewer, and Approver, all while ensuring comprehensive CSV compliance. It systematically organizes all documentation and records in a centralized repository, diligently monitoring every change to preserve data integrity and uphold Quality Assurance. Moreover, Validfor includes integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, which aid in conducting seamless impact assessments, tracking Corrective and Preventive Actions (CAPA), managing Computer Software Assurance (CSA), and overseeing audit-ready lifecycles. This all-encompassing strategy not only boosts operational efficiency but also fortifies compliance throughout a wide range of validation activities, making it an indispensable tool for regulated industries. In this way, Validfor empowers organizations to navigate complex regulatory landscapes with confidence and precision.

What is Carizma QM?

Carizma QM is a web-based tool crafted to help users manage the entire lifecycle of regulated documents, from the initial drafting and review phases all the way through to approval, release, and eventual archiving. It allows for the creation and oversight of crucial documents like Standard Operating Procedures (SOPs) via integrated workflows that promote efficient review and approval. Once a document receives approval, the system automatically triggers a training workflow, requiring users to confirm that they have read and comprehended the document. The application includes an electronic signature capability that adheres to 21 CFR Part 11 regulations, ensuring a record of users who have acknowledged their understanding of the documents. Furthermore, it provides a validated audit trail, which significantly aids users in managing regulated documents directly within Carizma QM. Authors have the ability to define important details such as the document type (including SOP, work instruction, form, or checklist), the title of the document, the process owner (designated department), and the applicable user groups, while also establishing a review cycle. Timely notifications are sent to users via email when their review of a document is necessary, and Carizma QM facilitates the creation of an initial document framework to make this process more efficient. By offering these extensive features, the software not only streamlines but also enhances the management of regulated documentation, ensuring compliance and efficiency throughout the entire process. Ultimately, Carizma QM serves as an indispensable resource for organizations seeking to maintain rigorous standards in their document management practices.

Media

Media

Integrations Supported

Integrations Supported

Adobe Acrobat
Microsoft Word

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
Chromebook

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub

Company Facts

Organization Name

Validfor

Date Founded

2024

Company Location

Estonia

Company Website

validfor.com

Company Facts

Organization Name

Axicos

Date Founded

2007

Company Location

Switzerland

Company Website

www.axicos.com/software-solutions

Categories and Features

Categories and Features

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