Digital Transformation Consulting For Regulated Industries.
Awards & Recognitions
IT Quality & Compliance
Digital Managed Services
Teva Pharmaceuticals Case Study
How Teva Pharmaceuticals Used migrationIQ™ to Merge Acquired QMS Records
Validating Enterprise Quality Management Systems
For regulated industries, validation teams
must comply with
regulations in conjunction with their internal procedures to validate new and existing web-based Enterprise Quality Management Systems (EQMS).
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®
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 this quick and easy 19-page eBook,
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.
Change Control Systems
'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, often referred to as non-conformances, errors, discrepancies, failures, or problems, are defined as unexpected or unplanned departures from current good manufacturing practices (cGMPs),
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),
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
Internal Quality Auditing
Internal Audit Management Software Solution and Internal quality auditing of pharmaceutical, biotech, medical device, consumer packaged goods and electronics manufacturing industry.
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.
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),
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
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.
500 Alexander Park,
Suite 103, Princeton NJ 08540