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 […]

Electronic logbooks, eLogBooks, or e-logs in the pharmaceutical industry aren’t exactly new. Many manufacturers have been using software for years to track equipment, production, and manufacturing of raw materials and finished goods. eLogBooks reduce paper use by eliminating paper documents, improving visibility into production processes, automating data collection with manual data entry, implementing risk management […]

Agility in New Areas of Life Sciences and Pharmaceutical Manufacturing Pharmaceutical manufacturing has traditionally relied on centralized facilities for mass pharmaceutical production and distribution. As good as this method is, it may be limited when looking at the larger industry trends. This method guarantees product quality and consistency, but its rigidity prevents new manufacturing methods […]

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 […]

Corrective and Preventive Action in Pharmaceutical Industry The use of data is an integral part of every system and sector. One core sector where data is so highly valued is the pharmaceutical industry. Not alone does this industry use data, it also places a premium on data integrity.In this blog post, we will analyze what […]

¡Vamo a Darle! EIS PR is Open for Business! Today, EIS Inc. announced the opening of Enhanced Information Solutions Limited Puerto Rico Liaison Office. EIS Puerto Rico is a 100% owned subsidiary of EIS Inc. and is established as part of EIS’s strategic objectives and client focus to provide high quality consulting and manufacturing system […]