Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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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.
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.
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.
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.
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.
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.
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:
We provide extensive GMP consulting and regulatory services to help keep our clients ahead of the needs and expectations of regulators.
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Ebook About this Ebook In August, the revised EU GMP Annex 1 requirements, related to the Manufacture of Sterile Medicinal Products, were issued, starting the clock for …
Telephone:
Rephine HQ, UK
+44 1763 853135
Barcelona, Spain +34 934 178065
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