Audience
Healthcare companies wanting a tool to streamline their collaboration and regulatory adherence
About K2C PSMF Solution
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.
Other Popular Alternatives & Related Software
Drug Safety Triager
Drug Safety Triager is Clarivate's next-generation pharmacovigilance software designed to assist life sciences organizations in meeting regulatory requirements. This GxP-validated, compliant, and audit-ready system manages and streamlines the literature review workflow, enabling pharmacovigilance experts to focus on patient safety by simplifying literature review processes. The platform is fully validated and compliant with the reporting requirements of global safety regulatory agencies such as the FDA and EMA. Each implementation of the Drug Safety Triager is delivered with a validation package. The validation process and associated documentation align with the pharmaceutical industry and health authority regulations. All literature references undergo a systematic review process that automatically captures all users’ actions and adds a permanent, non-editable audit trail to the record.
Learn more
MSB Docs
MSB Docs simplifies digital document management for businesses of all sizes with secure, compliant, and legally binding Electronic Records and Electronic Signatures (ERES). It complies with US FDA 21 CFR Part 11, EU GMP Annex 11, and EU eIDAS (SES, AES, QES), making it ideal for regulated industries like healthcare and life sciences, while enabling cross-industry use across the EU.
In India, MSB Docs adheres to the IT Act 2000 and supports DSC, Aadhaar-based eSignatures, and eStamping, making it the most trusted digital documentation platform.
Trusted by leading organizations in pharma, BFSI, government, and education, MSB Docs offers:
1. eSign – Compliant digital signatures
2. CRA App – Simplified Clinical Research Associate workflows
3. Smart Forms – Dynamic, logic-based digital forms
4. eStamp – Legally valid, tamper-proof stamping
MSB Docs enables organizations to digitize, manage, and automate document workflows.
Learn more
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry.
This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others.
The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience.
SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.
Learn more
PvEdge
PvEdge is a cloud-ready pharmacovigilance software designed to provide end-to-end compliant safety solutions for drugs, devices, vaccines, and combination products. It offers a comprehensive safety database that manages pharmacovigilance intake, case processing, submissions, AI & analytics, and safety signals all in one platform. The system adheres to existing and upcoming regulations, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring global compliance. PvEdge utilizes advanced automation powered by AI and machine learning algorithms to enhance efficiency in drug safety database management. Key features include automated literature monitoring, ICSR submissions, smart triage, automated signal detection, and document automation. The platform also provides a controlled document management system for creating, managing, and publishing pharmacovigilance documents, as well as a risk-based enterprise quality management system to implement quality processes and training records.
Learn more
Pricing
Starting Price:
€8,500 one-time payment
Free Trial:
Free Trial available.
Integrations
Company Information
K2C
United Kingdom
www.k2c.com/products/K2Pharma/PSMF.html
Videos and Screen Captures
Other Useful Business Software
Build Agents and Models on One Platform
Gemini Enterprise Agent Platform is Google Cloud's comprehensive platform for developers to build, scale, govern, and optimize agents and models. Choose from Google's most advanced models and third-party models like Anthropic's Claude Model Family.
Product Details
Platforms Supported
Cloud
Training
Documentation
Live Online
In Person
Videos
Support
Phone Support
24/7 Live Support
Online
