TrackWise
TrackWise® created by Sparta Systems, is the most trusted Enterprise Quality Management System (EQMS).
It is the world’s leading QMS software. It integrates all quality processes into a single platform and helps to their automation. It offers workflows based on industry best practices, but also allows being adapted to any process or need.
TrackWise Digital
TrackWise Digital®, alternatively, is Sparta Systems’ cloud-based QMS software.
It is the industry’s leading global quality and regulatory compliance platform that enables getting the most out of your investment to quickly implement a quality management system in the most cost-effective manner.
Manage internal, external and regulatory audits. Initiate both, planned or unplanned deviations. Take advantage of machine learning and natural language processing to automatically classify incoming complaints and quality events. Perform risk assessment, determine root-cause and initiate and manage CAPAs within an integrated solution.
What Rephine Offers
Implementation
After a rigorous process for becoming certified by Sparta, we have a powerful and experienced team to implement TrackWise systems according of each client’s requirements. These requirements are captured through different workshops and subsequent prototypes are made.
Validation
We have a validation team that helps the customer to validate the configured system according to their requirements and computer system validation policies, following the complete system lifecycle and reducing the time required for Go-Live.
Training
Rephine and Sparta Systems have a lifecycle approach for the training activity. A variety of courses have been designed to ensure that your team gets suitable experience and knowledge to maximise the advantages of using the software, maintaining it and introducing enhancements, whilst supporting professionally the TrackWise user community.
Maintenance & Enhancements
Our TrackWise team of experts can provide ongoing assistance to help you maximising the success of your Quality Management System, implementing new processes, improving the existing ones or rolling them out in new sites, divisions or business areas.
Client Commitment
Faithful to our commitment to provide our clients with the best and most advanced services, we have been partners of Sparta Systems since February 2013.
This will allow us to extend our services of implementation and improvement of Quality Management Systems (QMS), to the automation and optimization of key quality processes, using the best eQMS platform available today: Trackwise® and TrackWise Digital®.
As a result, a clear benefit for our clients:
- Robust, reliable and fully compliant Quality System processes.
- Transparency and visibility of quality records.
- Efficient operational workflows designed according to both best practices for each industry and to customers’ organizations at a time.
- Compliance with cGMP, 21CFR Part 11 and Annex 11 of EU GMP
Where do you Need our Help?
For GMP Auditing, Quality Assurance & Digitalisation, we’re the partner of choice for all the stakeholders we deal with.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.
Global Audit Library
Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit
GMP Audit Services
Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise
GxP Consultancy
Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards
Digitalisation
From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements
Related Resources
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REPHINE CHINA
- Shanghai, China
REPHINE INDIA
- Hyderabad, India