especially when the industry is in an active state of change. The standards which work for a mature enterprise with an extensive portfolio of market-approved drugs aren't the right standards for a small, pharma startup with a globally distributed workforce. ...
CQ has all the functionality needed in support of a global QMS. Implementation includes; Document control, change order, personnel training, NC/CAPA, equipment management, supplier management, audit management, and customer complaints all on a single platform. As a small biologics company it was ...
Furthermore, in process manufacturing, one step must be completed before the start of the next step. In addition, the process itself is completed under specific conditions in terms of heat, time and pressure. These conditions during the production process result in thermal or chemical conversion, ...
With the arrival of platforms like Veeva, a major technological barrier has been breached in life sciences. Pharma companies are no longer forced to utilize a dozen different systems to get their products to market. With Veeva Vault handling all the tasks previously done by your RIMS, eTMF, CT...
For example, there is an audit in process, and your personnel is running helter-skelter trying to locate the Batch Records of a particular product. With the implementation of an efficient Electronic Batch Record management solution or an eQMS like SimplerQMS, you will not face such problems. At...
Figure 1:A high-level process flow indicating some of the elements of data governance, data quality, and data integrity, as well as the quality management system (QMS). This process flow has been translated into the Lego brick model shown inFigure 2. This model is based upon a data qualit...