Are you compliant?
The authorities require that you as a Life Science company have a working written change control and deviation handling procedure:

FDA Regulative, CFR Title 21 Subpart F - Production and Process Controls §211.100 - Written procedures; deviations (a) “There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall include all requirements in this subpart. These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. (b) Written production and process control procedures shall be followed in the execution of the various production and process control functions and shall be documented at the time of performance. Any deviation from the written procedures shall be recorded and justified”.

But have you considered what happens in real life? Most deviations are due to various reasons not handled 100% according to the procedures. Often document signatures are made by people having the wrong roles or not participating in the according project. It is also often seen that signatures falls in a timely disorder or are delayed waiting for the correct people to sign off at a specific phase in the documents life-cycle. This is of course not happening at your company, or is it?

Solve it
All this is unnecessary document disorder and delay. GMP is all about planning ahead and showing control. This is what QAchange™ enables you to do:

• Define your templates and workflow according to existing SOPs
• Relate roles to different actions or approvals in the document
• Create projects by affiliating users to roles
• Enjoy the system managing all document manage­ment according to the pre-defined rules

Electronic change control process ensures not only savings in time and cost but also better collaboration, visibility for management and undisputable audit trails of electronic signatures in compliance with FDA’s 21 CFR Part 11. QAchange™ furthermore secures traceability in the entire process, and can interface with the other QAtor’s suite products.

With its focused industry templates and protocols, electronic signature functionality, change control processes, integrated workflow, and security features, the Quality Assurance suite is particularly well suited for companies that need to enforce regulatory compliance to strict quality control measures. By providing exceptional visibility and transparency, control and management, the solutions enable companies to more efficiently manage compliance requirements through controlled electronic repositories, process automation, collaboration, communications, archival, and business integration capabilities in audited and tightly managed environments.

Key Features

• Provides Electronic Change Control, Change Request and deviation handling process
• Customizable forms with enforcement of required fields
• Manages electronic reviews and approval process with workflow engine
• Seamless integration with QAssure™ and QAcii™
• Real time statistical reports for all documents and projects
• Faster review and approval process
• Ensures full control and audit trail
• Improves quality, adds transparency and address regulatory concerns

System Requirements

• CLIENTS: Microsoft Internet Explorer v6.0™ and Adobe Reader™
• SERVER: Oracle Database v10G or higher

 

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