Are You Compliant?
FDA regulative 211.184 (c)
“An individual inventory record of each component, drug product container, and closure and, for each component, a reconciliation of the use of each lot of such component. The inventory record shall contain sufficient information to allow determination of any batch or lot of drug product associated with the use of each component, drug product container, and closure”.

QAcii™ provides a simple and easy-to-use, cost and time saving tool for company wide enforcing and supporting GxP and 21 CFR Part 11 compliance efforts in the areas of Configuration Management, Configuration Item Indexing (CII), and Baseline reports.

The web-based interface of QAcii™ uses a powerful backend database in which it structures data and maintains information on configuration items, such as software, hardware, operating system, control system, applications, libraries, raw data, as well as the relationships between them. QAcii™ ensures that a consistent inventory of IT assets is effectively manag­ed at all times across well co­ordinated team members and depart­ments.

With QAcii™ you have an easy and powerful way of monitoring hardware configuration and software installation data over the network, enabling professional system administrators to track and manage system contents throughout the entire lifecycle electronically.

With QAcii™ you can be certain that all information is accurate and current.

CI Lists
The CI list is one of the most important reports in GxP compliant environments to ensure that all systems are under control. It provides a list of all systems and every change made during the given time period. CI lists can be generated at several different organizational levels.
The easy to use reporting tool can be configured for your company specific layout. In addition, you can check for discrepancies between asset information in the database and the actual assets that are deployed in the company, with little chance for missed-records.

Version Control for All Configuration Levels
The key requirement in GxP compliant environments is to track changes in system configurations. The QAcii™ uses automatic version control to ensure that every change in the controlled systems is documented according the GxP requirements. Version number of the system is automatically updated with a reference to change request. Configuration versions are not only managed on system level but also on site and section level. By site level version control every single change to any system in the selected site can be traced. Full version history and audit trail information are available in Baseline and Audit trail reports.

Key Benefits for Life Science Companies

• Easy and fast product annual review
• Always up-to-date CII Lists to track status and changes
• Ensures full control and audit trails
• Improves quality, adds transparency and address regulatory concern

Application Features

• Web-based easy-to-use interface
• Electronic Configuration Item Lists (CIL) for hardware, software, documents and networks
• Automatic version management for Sites, Sections and Systems
• Search and retrieve functionalities
• Intensive activity logging for security and full audit trail
• Configuration management (CII) of all platforms, such as PLC systems, VMS, UNIX, Linux, Windows and network elements etc.
• Pre-defined reports with portable PDF file export: Baseline, Configuration Item List (CIL) and Audit-trail
• Various contract type tracking and management

System Requirements

• CLIENT: Microsoft Internet Explorer v6.0™ or Netscape 7.0 and higher, Adobe Reader™
• SERVER: Oracle Database v8 or higher