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 […]

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 […]

How to Improve Manufacturing Operations with Review by Exception As the pharmaceutical industry grows ever more competitive, operations are continuously looking for ways to reduce overhead and production costs- without compromising quality and safety. Quality assurance (QA) plays a key role in ensuring that only products which meet acceptable criteria are produced and measures are […]

OpsTrakker enhances life sciences operations by eliminating paper while improving efficiency, facilitating compliance, and unlocking manufacturing data.

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 […]