21 CFR Part 11: A Brief Overview of cGMP Manufacturing companies in the life sciences must follow FDA 21 CFR 11 and EU GMP Annex 11 requirements in order to sell products in the US and EU. As many organizations across the industry scale up production from clinical to commercial operations, adequate documentation and access […]

As the pharmaceutical industry continues to experience a great wave of growth, it is hard not to mention advanced manufacturing. As a result, advanced manufacturing has become a buzzword often used when discussing the future of factories, including pharmaceutical manufacturing. Combining its various elements aids effective pharma production while it brings flexibility. So stay glued […]

Electronic Forms for Work Instructions and Data Collection Paper-based data collection method has helped companies immensely. Sadly, it cannot keep up with the technological advancement pace, so it has to be substituted with electronic forms.Let’s discuss how electronic forms are changing the industry and the benefits of using electronic forms for work instructions, workflows, and […]

Why Switch to Electronic Room Cleaning? Maintaining a clean manufacturing environment is essential in pharma. The efficacy and compliance of your products and processes relies on accuracy and precision at every step of the manufacturing journey. And that starts with cleaning validation.If clean rooms, surfaces, equipment or packaging is not cleaned thoroughly, entire batches can […]

OpsTrakker Electronic Logbook Software Version 1.3 Enhanced Information Solutions announces the release of OpsTrakker Version 1.3, a powerful electronic logbook solution that replaces paper systems for highly regulated GMP manufacturing. Combining an HTML5 web console with a browser-based or native mobile app, OpsTrakker delivers form authoring functionality with mobile execution agility. This release includes functionality […]

OpsTrakker Mobile App Provides Significant Improvement to Manufacturing Operations Enhanced Information Solutions (EIS) Inc. today released the results of a study that analyzes the realized business benefits of an equipment logbook mobile solution for a major biotech company. This solution, as one module in OpsTrakker, went live in production in early 2015 to provide equipment use […]