Displaying 1–25 of 83 results for QRM Process
the results and analysis of a recent industry survey indicating the need for an integrated, systematic approach to corrective and preventative action.
As pharma companies look more and more to biologics for their next potential blockbusters, they must face the challenges surrounding these products' scientific complexity and sophisticated development.
It would be foolish to underestimate the risk associated with aseptic drug processing. Drug safety, secure uninterrupted supply, as well as regulatory imperatives dictate that drug makers create intensive and verifiable systems to assure sterility in aseptic processing environments.
Learn how partial proof testing of level instruments can save millions of dollars and maintain required safety ratings.
This eBook reveals how well-designed, well implemented information technologies can fulfill the lab’s critical mission.
Explore MasterControls’s quality, compliance and risk management solutions addressing these challenges.
This white paper contains expert insights on how to much more effectively manage Environment Monitoring in manners that increase efficiency, increase compliance and decrease risk.
This eBook discusses application of machine vision technologies in pharmaceutical packaging.
This white paper, first in a series of three, is to help executives and managers assigned to provide due-diligence of prospective contract manufacturing partners a framework in which to make a solid, objective evaluation of its overall operational excellence as it relates to quality.
This Pharmaceutical Manufacturing eBook shines a light on the full-time value of real-time diagnostic data to help managers understand more deeply the quality and risk management benefits that their connected control devices can bring.
Why Companies Need Best-of-Breed ERP and EQMS and how PLM fits into the mix
This executive summary from GE Analytical Instruments discusses an advancement in Conductivity analysis technology that can significantly reduce the time spent to comply with the USP <645> regulation.
The FDA mandates the validation of environmental conditions that can affect the strength, identity, safety, quality, and purity of pharmaceuticals, medical devices, or biologics.
To meet important regulatory challenges, it is imperative that manufacturers have a quality management system to manage processes and provide timely access to relevant data, effectively and efficiently.
This white paper will look at how risk management provides the framework for handling adverse events in a systematic way—from design, to post-market events, to tracking and trending risk across the enterprise.
Vaisala recommends a 9-point process for successfully validating a GDP compliant warehouse or other storage space.
Learn how companies can move on from solubility when it comes to cleaning validation.
Since FDA introduced the term to the pharmaceutical industry in 2005, the concept of pharmaceutical quality by design (pharma QbD), a framework for building quality into pharmaceuticals during drug development has been slowly gaining ground. Discrete industries are no strangers to QbD. Now, ...
Experts often repeat the fact that no single analytical technology should dominate any pharmaceutical quality control toolkit.