K2C Change Management Solution is based on SharePoint and allows to manage the change control process for systems (equipment, utilities, software etc.) used by the company or organization, but even more: each system can be inventoried, assessed and maintained under control, from the purchasing up to testing, validation. go-live and retirement, tracing at any time its status and speeding-up the more time-consuming activities.
The solution also allows to automate
the identification of required documentation for the system,
applying pre-defined rules that can be customized as per company
standards: this includes both technical and validation
documentation, required for those companies, such as
Pharmaceuticals manufactures or Life Sciences organizations, that need to comply with security, regulations and
other best practices or standards.
K2C Change Managemnt Solution includes the following main features:
System Assessment: technical classification, documentation and validation requirements, criticality as per applicable standards or regulations
Definition of Risk Assessment criteria basing on customizable rules
Definition of company policies for required documentation and validation activities
Automated definition of documentation and validation requirements, basing on system classification (assessment) and defined company policies
Change Request Management, from initial request up to criticality assessment, preliminary approval, reporting and verification of execution, final approvals and go-live authorization
Electronic Signature to ensure a fully paperless management of regulation requirements (21 CFR part 11, Annex 11 etc.) as per the change request of systems used in critical processes
Reports and indicators to monitor in real time the status of each system and related change requests
The solution is available in two alternative versions, respectively based on SharePoint Designer or Nintex workflows.
Contact us for more information or to request for a live demo.