Featured Articles
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3 Ways To Rethink Regulatory Change In Personalized Medicine
12/14/2021
The landscape for the regulation of personalized medicine evolves as innovation in personalized medicine increases. Here are a few ways to approach regulations as opportunities, not obstacles.
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What You Need to Know About Phase-Appropriate Quality Requirements
12/9/2021
A discussion on implementation of a phase-appropriate QMS, the importance of starting early in the product development life cycle, and the advantages of digital QMS over a manual approach.
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7 Steps To Ensure CAPA Success
12/9/2021
Product development in the life sciences is a multimillion-dollar process. With this level of money on the line, good corrective action/preventive action (CAPA) processes are essential. Here are seven steps you can take to take to successfully complete and document CAPA.
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Planned Deviations Vs. Unplanned Emergencies: Real-Time Manufacturing Intelligence Is The Difference
12/6/2021
Today’s top life sciences manufacturers are dramatically reducing deviations with real-time intelligence. Going digital gives you the power to track and control deviations. Our webinar will show you how.
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ISO Standards: Turning Hopes Into True Quality Objectives
11/22/2021
Aligning your company’s quality management practices with the applicable quality principles found in the ISO 9000 family of standards is a proven approach for turning aspirations into actual quality objectives. Here, we review key quality principles addressed in ISO 9001 and examples of ways the standard can be leveraged to reach the kinds of objectives your organization may be looking to achieve.
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Why Is Pharma Resistant To Digitization?
11/22/2021
Digitizing what basically amounts to a ruled notebook into an electronic solution sounds like an easy win. It’s when you start to dig deeper that this task can quickly become burdensome, especially when presenting the proposed process map and data workflow to a steering committee.
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FDA Inspection Preparation: SOPs, Process Maps, And Gap Analysis
11/22/2021
Process mapping and gap analysis can help manufacturers not only show the FDA that an organization is compliant with regulatory expectations, but also help demonstrate that standard operating procedures (SOPs) are correct and that employees understand them.
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MasterControl Announces Annual Recurring Revenue Milestone
11/18/2021
MasterControl, a global provider of software solutions for life sciences and other regulated industries, today announced it has reached $100 million in annual recurring revenue (ARR), led by their signature software solutions, Quality Excellence and Manufacturing Excellence, as well as the recent launch of MasterControl Insights.
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A Risk-Based Approach To Supplier And Vendor Audits
11/5/2021
With the right tools, supplier and vendor audits can be an effective mechanism for gaining visibility into a supplier's process and improving product quality. Digital supplier quality management tools can dramatically enhance supplier audits and vendor qualification audits.
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5 Ways Digital Technology Will Transform The Supply Chain
11/5/2021
When data is digitized and connected to other data points across the enterprise by the IoT, and analyzed by AI algorithms, the data becomes more visible, usable, and valuable. Several technologies have emerged to help life sciences companies excel in an increasingly digital economy. Here is what five of these technologies mean for the life sciences supply chain.