Quality Assurance Management Software For Pharma

By Author: caliber universal
Total Articles: 2
Comment this article

Enterprise wide Change Control, Non-conformance/Deviation and CAPA Management

Business Challenge:
Need of scalability and transparency on status of deviations from various locations and related departments, there was a need for a better solution to control the quality of relevant data using a closed loop change control process that was automated, centralized, and easily visible by all levels of management.
The ideal solution was an enterprise quality management software system that was configurable, could support company growth, and document any deviations and the resulting investigations, corrective and preventive actions (CAPAs), change controls, and effectiveness checks.
Solution and Implementation
With CaliberQAMS actionable analytics, monitoring open incidents, location and department wise is very effective. Using the web-based software, management can now easily run targeted reports and gain access to critical decision-making information. The ability to create personalized quality dashboards encouraged a cross-collaborative environment eliminates errors and wasted time.
Prior to ...
... CaliberQAMS, our client relied on Excel spreadsheets to compile and share information with senior management.
There are more than 200 reports to help you to track and make informed decisions and to give an enterprise and plant wide view. There are drill down dashboards for all levels in the organizations like dashboards for CQA, plant managers, QA &QC heads to view deviations, change controls from all locations and drill-down to last detail of the incident;
Perato-chart,a very useful chart which tells you the cause of the incident( human errors, negligence or equipment failure) and helps to get to robust preventive action. Plant wise pendency reports with dashboard to the QA head helps to keep track of incidents and their CAPA. Quick status reports on issues and their causes eg Human Errors, negligence, Equipment failure. Different kinds of performance index reports eg Issue Cycle, Issue login, Action plan, Plan tasks
Apart from the above, CaliberQAMS has reporting engine which helps you deliver reports for your business no matter what business you are in. Your users shouldn’t have to jump through hoops to understand their own data. Your customers have very specific needs, and you don’t want to spend an undue amount of time designing templates or worry when they want to run a report. We make it easy to update and modify reports based on your customer’s needs.
Switching to an electronic system came with initial scepticism; however, due to effective training and configuring existing process to software staff found the implementation and transition to be quite smooth.
Results
Client officially rolled out 10 locations(India, Japan) with 2000 users, who are now using the technology to track and manage deviations, investigations, CAPA, change controls and effectiveness checks, resulting in improved management of the organization’s overall quality metrics reporting process. The Company now has access to accurate data in a timely manner which increases the level of information sharing in a much clearer, precise format.