+
+

Related Products

  • Qualio
    858 Ratings
    Visit Website
  • ONLYOFFICE Docs
    715 Ratings
    Visit Website
  • Encompassing Visions
    13 Ratings
    Visit Website
  • PDFCreator
    535 Ratings
    Visit Website
  • Nutrient SDK
    108 Ratings
    Visit Website
  • Apryse PDF SDK
    153 Ratings
    Visit Website
  • MobiOffice
    14,464 Ratings
    Visit Website
  • MobiPDF (formerly PDF Extra)
    6,998 Ratings
    Visit Website
  • Medsender
    28 Ratings
    Visit Website
  • Interfacing Integrated Management System (IMS)
    66 Ratings
    Visit Website

About

K2C PSMF Solution is a modern approach to the management of the Pharmacovigilance System Master File. This document typically requires periodic updates as per significant changes in the pharmacovigilance process. These changes require that multiple company roles are involved in editing a document that is composed of paragraphs and annexes that are all the time same because fixed by regulations. However co-editing is complex; in addition, part of the content should be reserved to some editors and even not available to other contributors. K2C solution allows handling the distinct paragraphs and annexes as single documents, then it offers the possibility to create the PSMF document as a merge of various source documents. K2C PSMF Solution includes management of PSMF contributions (paragraphs and annexes) as distinct documents; management of access rights for viewing or editing of PSMF contributions; and management of the entire lifecycle.

About

K2C eSignature enables the use of SharePoint (from 2010 up to 2019 version) to electronically sign any document or record in compliance with US 21 CFR part 11, European Annex 11 and similar regulations. After the installation, a new action "eSignature" is available both in SharePoint Designer or Nintex workflow, if you are using this additional tool. This action can be added at any step of the workflow, in order to collect one or more user signatures without the need of any custom development or coding knowledge. Including views to verify eSignature records for selected item/document and reports dedicated to managers in order to display all electronically signed items/documents in a given SharePoint site and in selected year/month. Able to dynanically retrieve the appropriate signer from any SharePoint list that is managing the assignement of company roles.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Healthcare companies wanting a tool to streamline their collaboration and regulatory adherence

Audience

SharePoint users that want an esignature solution

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

€8,500 one-time payment
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

K2C
United Kingdom
www.k2c.com/products/K2Pharma/PSMF.html

Company Information

K2C Solutions
Founded: 2001
United States
www.k2c.com

Alternatives

PvEdge

PvEdge

Sarjen Systems

Alternatives

Certinal eSign

Certinal eSign

Certinal
SPListX for SharePoint

SPListX for SharePoint

Vyapin Software Systems
AIFMD Annex IV Reporting

AIFMD Annex IV Reporting

Matterhorn Reporting Services

Categories

Categories

Digital Signature Features

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

Integrations

Microsoft SharePoint

Integrations

Microsoft SharePoint
Claim K2C PSMF Solution and update features and information
Claim K2C PSMF Solution and update features and information
Claim K2C eSignature for SharePoint and update features and information
Claim K2C eSignature for SharePoint and update features and information