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”.
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.
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.The version number of the system is automatically updated with a reference to change requests. 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.
ELECTRONIC CONFIGURATION ITEM LISTS(CIL)
FDA AND GMP COMPLIANT
WEB BASED EASY- TO-USE INTERFACE
- Automatic version management for Sites, Sections, and Systems
- Intensive activity logging for security and full audit trail
- Predefined reports with portable PDF file export : Baseline , Configuration Item List (CIL) and Audit-trail
Over 50 years of combined life science and Quality Assurance experience within Qator A/S.
Applying the newest tools and methods to enhance your company’s success, by improving compliance and traceability.
Possibility of intergration with other systems.