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ease
features
design
support

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Description

The K2C PSMF Solution represents an innovative methodology for overseeing the Pharmacovigilance System Master File. Periodic updates to this document are essential whenever there are noteworthy modifications in the pharmacovigilance procedures. Such modifications necessitate collaboration among various roles within the company to edit a document comprised of consistent paragraphs and annexes dictated by regulatory standards. However, coordinating edits can be challenging, especially since certain content must remain exclusive to specific editors and inaccessible to other contributors. The K2C solution addresses this complexity by treating individual paragraphs and annexes as separate documents, facilitating the creation of the final PSMF document through the merging of these various source materials. Additionally, the K2C PSMF Solution encompasses the management of contributions to the PSMF (including both paragraphs and annexes) as distinct entities, the regulation of access rights for both viewing and editing contributions, and comprehensive oversight of the entire document lifecycle, ensuring efficiency and compliance throughout the process. This streamlined approach enhances collaboration while maintaining regulatory adherence.

Description

K2C eSignature provides the functionality to electronically sign documents or records within SharePoint environments ranging from the 2010 to 2019 versions, ensuring compliance with US 21 CFR part 11, European Annex 11, and other related regulations. Once installed, users gain access to a new "eSignature" action that can be utilized in SharePoint Designer or Nintex workflows, depending on whether this additional tool is used. This action can be seamlessly integrated at any stage of the workflow, allowing for the collection of one or multiple user signatures without requiring any custom programming or technical expertise. Additionally, it includes features for viewing eSignature records for specific items or documents, along with tailored reports for managers that showcase all electronically signed items or documents within a designated SharePoint site for a selected year or month. Furthermore, the system can dynamically pull the relevant signer from any SharePoint list that tracks the assignment of company roles, thereby streamlining the signature process. With these capabilities, K2C eSignature significantly enhances the efficiency and compliance of document management within organizations.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Microsoft SharePoint

Integrations

Microsoft SharePoint

Pricing Details

€8,500 one-time payment
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

K2C

Country

United Kingdom

Website

www.k2c.com/products/K2Pharma/PSMF.html

Vendor Details

Company Name

K2C Solutions

Founded

2001

Country

United States

Website

www.k2c.com

Product Features

Product Features

Digital Signature

Audit Trail
Authentication
Auto Reminders
Customizable Templates
Document Analytics
Mobile Signature
Multi-Party Signing
Progress Tracking
Task Progress Tracking

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