Since our founding in 2008, Process StreamTM has developed extensive insights into the quality management process. Included below are brief explorations of specific areas of our expertise.
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Adverse events are undesirable effects that occur after the use of a medication, medical device, pesticide, vaccine or other biological product. They may, or may not, be caused by the product or device.
A Corrective Action / Preventive Action (CAPA) system is for developing, approving, tracking, implementing, and determining the effectiveness of corrective actions and preventive actions resulting from deviations (non-conformances), complaints, product recalls, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring.
Process StreamTM's Experts Help Reduce the Cycle Time for Engineering Changes, Improve Change Customization, Tracks the Change Process, Perform Reviews & Changes
Deviations, often referred to as non-conformances, errors, discrepancies, failures, or problems, are defined as unexpected or unplanned departures from current good manufacturing practices (cGMPs), regulations, standards, procedures, or specifications that may affect a product’s safety, quality, identity, potency, or purity (SQIPP).
Developing and implementing an electronic quality system is a very exciting project to be a part of. This is a great opportunity to take a holistic approach in evaluating what your requirements are for the system and how that system will fulfill those needs.
There are many factors that make up an IT project. For one, you need people of the right skill set to analyze and build your application.
Internal Audit Management Software Solution and Internal quality auditing of pharmaceutical, biotech, medical device, consumer packaged goods and electronics manufacturing industry.
There are several things to consider before developing / implementing an electronic quality system. The ideal of an electronic quality system is to be able to gather, store and retrieve data in a consistent and integral manner. The following seven concepts should be kept in mind when developing your electronic quality system.
There are four main components to a well established training program which should be considered for your electronic quality system: procedures, hands on training, experienced / knowledgeable trainer(s), and a measure of training effectiveness.
Emergence of cloud computing, software as a service (SaaS), service oriented architecture (SOA) and adoptable standards in open source development have changed the way enterprises establish application infrastructure and approach enterprise application integration (EAI).