Resources

Resources

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.

Get the Most Out of TrackWise®
Get the Most Out of TrackWise®

Is your TrackWise® implementation everything it could be? In this free webinar, Sparta Systems’ Technical Account Manager Jon Ragati is joined by Nisha Allen and David Hollingworth from ConvaTec to discuss how TrackWise® can be leveraged to transform your business into a lean, mean production machine – all while using its powerful compliance processes to minimize your risk.

TrackWise®
TrackWise®

Whether you’re a new TrackWise® user or someone with experience on the platform, there are always new things you can learn to make it even more valuable to your organization. In thisquick and easy 19-page eBook, you’lllearn valuable skills to help you take advantage of TrackWise®’s powerful quality management tools - straight from our team of Sparta-accredited experts. We've successfully implemented hundreds of Trackwise® projects.

Adverse Events
Adverse Events

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.

CAPAS
CAPAS

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.

Change Control Systems
Change Control Systems

Process StreamTM's Experts Help Reduce the Cycle Time for Engineering Changes, Improve Change Customization, Tracks the Change Process, Perform Reviews & Changes

Deviations and Risk Management
Deviations and Risk Management

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).

Electronic Quality Systems
Electronic Quality Systems

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.

High Performance Teams
High Performance Teams

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 Quality Auditing
Internal Quality Auditing

Internal Audit Management Software Solution and Internal quality auditing of pharmaceutical, biotech, medical device, consumer packaged goods and electronics manufacturing industry.

Quality Management System Considerations
Quality Management System Considerations

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.

Training for Your Electronic Quality System
Training for 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.

Web Services Integrations
Web Services Integrations

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).