Managing The Expectations Of Auditors For Microbial Data Collection

By Paola Lazzeri, EMEA Sterility Assurance & Microbiology Product Specialist and Giulia Artalli Global Product Line Manager

The adoption of computers and automation in modern industries has dramatically increased the amount of data to be managed. Digitization, the fourth revolution of industrial manufacturing after steam power, mass production and computer automation, allows industries to manage this data systematically and efficiently.

Over time, pharmaceutical manufacturers have changed their processes to separate operators from products. Today, several already use robotic filling lines, further blurring the line between digital systems and operations. Information technology is a growing need as more companies adopt these solutions to manage so-called "big data". Environmental monitoring (EM) procedures could eventually be completely integrated into digital systems, preventing deviations and errors. For example, microbial data collection might be managed exclusively through digital means. The significant volume of data generated from EM should be managed in compliance with good manufacturing practice (GMP) guidelines to ensure reliability and integrity.

Manufacturers must be able to guarantee their blend of automated and operational processes are under statistical control while ensuring their data is secure and accurate. With the improvements made to other areas of production, there is a growing need for modern solutions to environmental monitoring and microbial data collection in critical areas.