With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec. And when it isn’t, as will sometimes (albeit rarely) happen, the manufacturer can step in more quickly than ever before to limit the volume of OOS product — saving time, money, and staying ever closer to the ideal quality standard.
How a proactive approach involving predictive — rather than preventive — tools to identify deficiencies before they compound and become actual problems can result in a healthy bioprocessing facility.
Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times. CRB was able to help a biotech company improve their Global Documentation Change Control Process quickly and easily.
Current market conditions such as regulations and mergers or acquisitions make improving compliance and manufacturing efficiency while driving to grow revenue and margins difficult. Read on to understand strategies, frameworks and recommendations to achieve these goals.
A platform’s integrated business framework helps dental implant and medical device manufacturer eliminate traditionally disconnected processes and data and increase the efficiency and accuracy of its product quality control.
Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). By Karen Redding, Global Business Development Director, Phlexglobal Ltd.
MedAvante is a global provider of centralized, expert psychological rating services to the pharmaceutical, biotechnology, and medical device industries.
Technology, enabled by the Industrial Internet of Things (IIoT), is empowering organizations to shift to a holistic and operations-centric view where proactive and predictive maintenance (PdM) enables front line personnel in life sciences to act before costly failures occur.
Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers.
Pharmaceutical companies work throughout their supply chain in a field dominated by regulations and demands for high quality.
