Holistic Approach to Data Management for Pharmaceutical Manufacturers

Holistic Approach to Data Management for Pharmaceutical Manufacturers Written by Nina Morton Sept 25, 2018, Boulder, CO – Particle Measuring Systems (PMS) and Novatek International have partnered to create the first fully integrated cleanroom data management system, PharmaIntegrity, to securely meet regulatory requirements and ensure product integrity. This combination allows pharmaceutical manufactures to quickly and easily set up a…

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Cleaning Validation Workshop | Mumbai, India

Novatek will be sponsoring and exhibiting at this year’s Cleaning Validation Workshop hosted by UBM & CPhI: Cleaning validation plays a crucial role to verify the effectiveness of cleaning procedures and ensure no risks are associated with cross contamination which harms the patient safety. Global regulatory authorities are keeping close eye on pharmaceutical companies to…

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2018 Cleaning Validation Summit | PharmaED Resources

Cleaning Validation Summit 2018 Cleaning Standards For Drugs and Devices From Industry Experts Are you up to speed on the new Science, Risk and Statistics based approaches for Cleaning Validation? Today’s regulators are now asking for, and expecting, ADE Monographs and Risk Assessments of Cleaning Validation Programs. This two-day intensive summit brings together industry leaders…

Lentigen Technology, Inc. Selects Novatek Environmental Monitoring Management Software

GMP manufacturing facility for Lentigen Technology, Inc. has chosen Novatek’s Environmental Monitoring (EM) software w/ mobile add-on as part of their dedicated EM program at their Gaithersburg, MD, USA  site. Novatek’s automated Environmental Monitoring software helps life science manufacturers evolve to a risk-based approach for their EM programs. The use of sampling data for the identification…

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IVT Cleaning Validation Aug. 2018

Back by popular demand!  Join us at IVT’s Cleaning Validation Event in Philadelphia in August! We will be presenting on Day 2: User Requirements and Implementation of a Risk Based, Compliant Cleaning Validation Management System Based on the Draft Guidance on Data Integrity In pharmaceutical manufacturing, risk of contamination is caused from a broad range of…

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IVT’s 6th Annual Microbiology Week

Join us at the 6th Annual IVT Micro Week as we lead an intensive breakout session on: Assess the Trending of Environmental Monitoring Data Based on FDA’s Data Integrity and Compliance with cGMP Dhttps://ntint.com/product/novatek-environmental-monitoring/raft Guidance Presented by: Marsha Steed, Principal Consultant Valsource, LLC & Sheba Zaman Head of Product Specialists & Training Services, Novatek International Other…

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A3P Cleaning Validation Workshop, France

Changes to the Chapter 15 Annex 10 of the European GMPs, applicable from the October, 1st 2015 for all pharmaceutical and veterinary drug manufacturers, have considerably strengthened the regulation on the Cleaning Validation. The latest version of 2001 contained only 7 paragraphs on the subject, when this new version contains 15! Join Novatek as we…

Ximedica Chooses Novatek Environmental Monitoring Software

Novatek International is pleased to announce that Ximedica has chosen Novatek’s Microbiology Environmental Monitoring software program for their Providence, RI manufacturing site.  The power of a dedicated environmental monitoring system will compliment Ximedica’s already existing systems to provide real-time data trending and the needed process-based feedback ensuring Ximedica’s EM processes are always in a state of control.…