Supply Chain Resilience
Most people take for granted that medication prescriptions will be ready at the pharmacy counter and available for pick up when ordered to get themselves...
Read MorePatients emerge as the ultimate beneficiaries of Aseptic Processing Technology advancements
Aseptic Processing Technology advancement innovations such as robotics, artificial intelligence, & rapid test methods have continued to ensure the production of safer, more effective medical...
Read MoreLESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 2– EXECUTING
This is the second in a series of three articles that present lessons that our validation team learned while completing a pair of validation projects...
Read MoreTransformative Power of Virtual Twins (Part 3 of 3)
This is the final installment of a three-part series exploring the transformative power of Virtual Twins as part of an asset induction effort for facility...
Read MoreTransformative Power of Virtual Twins (Part 2 of 3)
This is the second installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility...
Read MoreTransformative Power of Virtual Twins (Part 1 of 3)
This is the first installment of a three-part series exploring the transformative power of Virtual Twins when applied to an asset induction effort for facility...
Read MoreFive Keys to Successful Facilities Management
Facilities Management is a critical aspect of maintaining a safe and efficient workplace. It involves a wide range of tasks, from maintaining the physical infrastructure...
Read MoreLESSONS LEARNED FROM IMPLEMENTING THE FDA’s CSA GUIDANCE: PART 1 – PLANNING
After several years of conversation with drug manufacturers and consultants about the state of computer system validation, the FDA issued a draft of the Computer...
Read MoreRemote Regulatory Assessments – Q&A: Here to Stay
On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs). The FDA has...
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