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05.25.21 -- Are You Approaching LIMS Validation Correctly?


05.25.21 Are You Approaching LIMS Validation Correctly?
 
 
Sanofi wanted to upgrade from an existing batch chromatography process to the BioSMB multicolumn format, then scale up that process to a continuous perfusion run. This case study details the real-world results.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Industry Insights ....

Dominic Hyde , Stephen Natoli , Alex Nancekievill , Kashif Ghaffar , Jason Osman , Peter Poechlauer , John Mcguire , Todd Andrews , Gabriela Mikhaiel , Jeff Tremain , Lonnie Barish , Matthew Jones , Mike Dingle , Bora Pharmaceuticals , White Paper Alconox Inc , Nidec Group , Natoli Engineering Company Inc , Qa Ajinomoto Bio Pharma Services , Pharma Services , Thermo Fisher , Per Hammer , Natoli Engineering Company , Coperionk Tron , Ajinomoto Bio Pharma , Fisher Clinical , ஆதிக்கம் செலுத்தும் ஹைட் ,

05.04.21 -- How To Ensure Your Quality Culture Assures Data Integrity


05.04.21 How To Ensure Your Quality Culture Assures Data Integrity
 
 
Several biopharma startup veterans share their insight and inspiration on navigating clinical-stage regulatory considerations in this ebook.
Find advice and wisdom from biopharma leaders on:
      Chemistry, manufacturing, and controls (CMC) considerations for first-in-human studies,
      Gap analysis fundamentals,
      And the relationship between GMP and CMC.
 
Join Biotech Makers to network, share expertise, and get perspectives on common challenges. Collaborate and connect with your peers. Join Now.
Featured Editorial
By Chris Smalley, ValSource
One solution to ensuring data integrity is to automateBr processes, essentially removing the human element. But not all instances of data generation and capture can or should be automated. With humans our team members engaged in data generation and capture, ....

Comunidad Autonoma De Cataluna , Andrew Wong , Webinar Lonza , David Zimmerman , Paula Decaria , Alok Tayi , Danna Schwerdt , Andreas Meudt , Scott Martin , Derek Duncan , Jordan Ball , Michelle Nolasco Rivera , Jones Healthcare Group Packaging Services , Nikka Densok United States Inc , Case Study Flow Sciences Inc , Natoli Engineering Company Inc , Qa Stevanato Group , Solutions For Life , Evonik Corporation , Samira Shore , Thermo Fisher , Natoli Engineering Company , Brian Ball , Nikka Densok United States , Jones Healthcare Group Packaging , Mats Lundgren ,