A variety of solutions to manage your Quality System fully paperless, including SOPs, eLearning & Training, CAPA System, Quality Issues (Deviations, non-conformities, OOS, OOT etc.), Change Control, Risk Management and many more.
Our QMS solutions work both as independend or integrated applications, price starting from € 8.500
Get the highest ROI with K2C solutions for process digitalization and automation: we re-design your processes adopting the top technologies as per RPA, BPM and workflow tools.
Contact us to get a free assessment and return you a faseability analysis and cost estimate.
Audit Trail feature for SharePoint to fully comply with 21 CFR part 11, Annex 11or other similar regulations. This feature assures a strong control over any change of critical data, that can be configured to be under audit trail. This solution works for SharePoint server (standard or enterprise license).
Enable the use of SharePoint to electronically sign any document or record legally binding handwritten signature, in compliance with 21 CFR part 11, Annex 11 and other regulations about Electronic Record and Signature. This solution can be used both in SharePoint Designer and Nintex workflows.
Convert word to pdf and other optional features: file protection, digital signature and watermark. This solution can be used both in SharePoint Designer and Nintex workflows.
Add a Digital Signature to a PDF document already created and managed in SharePoint. The digitally signed pdf becomes strongly protected against any change after the approval. This solution can be used both in SharePoint Designer and Nintex workflows.
Add a watermark to a PDF from a SharePoint Library, simply selecting the file menu and specifying the text and position. Trial version is fully working, but an additional watermark will be displayed until a valid license key will be entered.
Download K2C White Paper for SharePoint Compliance to 21 CFR part 11, describing how to use our add-ins to fully meet regulation requirements.