Data integrity, transcribed in the industry, as the manufacturers’ responsibility to govern their facilities processes, operational efficiencies, and quality control test data. Quality control microbiology processes and advancements in technology have been proven to improve organizations’ confidence in sound data and quality in the GMP manufacture of products.

At the height of regulatory scrutiny, it is invaluable that we learn from each other and share our expertise and insights into process enhancements and improvements in keeping patient safety top priority. As we know, microbiology laboratories historically process at risk when utilizing manual operations, forcing error prone risks of data recording, subjective results reported, and arithmetic mistakes.

Our industry regulators are emphasizing the value and importance in the transition from manual-human error prone microbiology methods to automated technologies. Implementing integrated digital automation for quality control testing omits all deficiencies in the current (historic) state of manual microbiology, or traditional methods.

Regulatory bodies have an enhanced focus on data integrity forcing guidance on compliance and the importance of understanding process risks. Quality Risk Management (QRM) is the required ability to show risk awareness and effective mitigation strategies. Manual processes are difficult to mitigate, due to the human component, there is little evidence to track and prove compliance with subjective interpretation and record keeping, falsification or lack of authentic data.

Automation guarantees processes are followed, data is accurate, complete, auditable, and trustworthy. Today’s automated technologies for microbial test incubation, enumeration, and detection offer unprecedented capabilities to improve consistency, save time, reduce analyst error, capture data automatically, and manage control in confident results to maintain complete compliance to the stringent data integrity standards driving the industry.

In this webinar you’ll learn:

• Importance of data integrity in quality control microbiology
• Value of integrating automation Software & Technology to enhance data integrity
• Regulatory expectations on Data Governance and Quality Risk Management

• Directors of Quality Control 
• QC Microbiologists
• Pharma Manufacturers
• QC Lab Personnel