"Schiff’s culture and the knowledge and experience of the professionals and manufacturing personnel who participated in designing and creating the batch record documents made it possible for Schiff to meet FDA’s timeline for implementation of Part 111."
“Quatro has helped me especially in streamlining the review and approval process of QS documents and providing me a superb tool for assessing the compliance state of Actelion. For instance, the system’s search capabilities can readily show me the number of overdue QS documents for revision.”
ETQ, part of Hexagon, is the leading provider of quality, EHS and compliance management software, trusted by the world’s strongest brands. More than 600 customers globally, spanning industries such as pharmaceuticals, electronics, heavy industry, food and beverage, and medical devices, benefit from ETQ to secure positive brand reputations, enable higher levels of customer loyalty and enhance profitability. ETQ Reliance offers built-in best practices and powerful flexibility to drive business excellence through quality. Only ETQ lets customers configure industry-proven quality processes to their unique needs and business vision. ETQ was founded in 1992 and has main offices located in the U.S. and Europe.
Qualtrax is a powerful document control tool that has expanded to be much more. Now a true compliance software package, Qualtrax works with companies worldwide to assist them with achieving compliance goals. This includes not only managing documentation, but automating key business processes, streamlining training management, and ensuring critical industry regulations are addressed.
Intellect is a leading cloud based QMS and EHSQ software provider that helps you reduce your Cost of Quality (CoQ), improve operational excellence, and meet ISO, FDA, OSHA, EPA and GxP compliance. Intellect offers 30+ prebuilt applications – including Document Control, Employee Training, Audit Management, Nonconformance, Corrective and Preventive Actions (CAPA), and Change Control – that are available and ready to use out-of-the-box (OOTB). Intellect apps are designed by certified ISO and FDA experts to save you time, meet industry standards, best practices, and key regulatory requirements.