ChangeStream is a fully electronic Change Control Management Application to manage, track and consolidate under a single roof all activities pertaining to changes within a regulated environment

For whom

ChangeStream targets medium to large-sized organisations that operate under regulated environments and need to demonstrate tight control over their Change Control process.  Having been designed from the ground up to fulfill 21 CFR part 11 requirements, ChangeStream is ideal for Pharmaceutical companies and API manufacturers. 

Why you need ChangeStream

Many companies today are failing to manage change control through lack of efficient and accurate tools to manage the complete lifecycle of change management.  Companies still resort to manual procedures using a mixture of paper, spreadsheets, databases and electronic mail.  This manual approach increases the time to close off change control requests, and fails to provide a change control with a centric repository of information where users can easily and rapidly access all information and take accurate decisions in a timely fashion.

The usage of productivity tools such as excel and electronic mail that do not have provision for electronic signatures in compliance with 21 CFR part 11 increases the company’s exposure to non compliance.

ChangeStream is a collaborative application that manages the complete lifecycle of change from issue, assessment, approval to implementation and evaluation. 

Change requests can now be managed online, giving you total control on how change requests are managed with complete accountability of actions.  ChangeStream dramatically reduces the time from the issuance of the change request all the way up to its conclusion.

Highlights:

• Complete lifecycle of change from issuance to final evaluation
• Support for 21 CFR part 11 ER/ES
• Easy to use, 100% web interface
• Multi-Site support
• Include customers and suppliers within the change lifecycle
• Fast deployment,  integration with SAP R3 - HR for automatic synchronization with HR hierarchy
• Personalized and proactive email notification of pending actions