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Featured White Papers

GDP for APIs New Regulations

APIs, drug substances, starting materials or excipients… any name you give them, are now under strict GDP regulations to handle carefully, within temperature specification from the point of manufacturing at the API plant. This article will discuss 2015 bottom-line regulatory requirements for API suppliers and manufacturers – and what pharma manufacturers can do to ensure procurement of quality materials.
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Could Poor Temperature Data Management be Putting Your GxP Facility at Risk for Data Integrity Violations?

Did you know that 95% of data integrity problems arise inadvertently due to poor data management? Not intentionally, or corruptly, like the news likes to portray. Using old technology, especially in paper form like chart recorders or printed reports, increases risk in your laboratories that some error will be made in collecting, storing or retrieving in data. Moving to electronic data monitoring will help you automate processes and intelligently manage data while meeting new data integrity requirements from MHRA, WHO and FDA.
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Leading Minds Seminar Post Event Report, Discussion Findings & Practitioners Suggestions for Change

The second Leading Minds Seminar covered a range of topics including MHRA inspectorates feedback on GDPs for APIs, implementing a global data monitoring system, CRT policy, transport qualification and more. Read the report in 10 minutes, and take away the best points from 8 hours of great community forum discussions.
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Transitioning to the Modern World of Data Monitoring and Analysis

Processing excursions and conducting quality investigations use extensive resources. Ineffective data handling processes can take so much time, some companies never get to value add activities such as trending cold chain data. Today, with the cost-effective technology available, that should never be the case. So why isn’t every pharmaceutical company using a state-of-the-art data monitoring system with advanced reporting and analytics capabilities?
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Warehouse Mapping of GxP Storage Facilities: Why it’s Not an Option

When your warehouse stores temperature sensitive pharmaceuticals and life science products, a top of the line HVAC system with carefully placed thermostats is not enough to ensure product quality and consumer safety. Why? It is the nature of warehouse facilities, no matter the size, to experience temperature gradients.
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