Featured Articles
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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.
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Developing An Effective Supplier Scorecard
11/4/2021
The supplier scorecard is an effective form of communication because it sets up a structured measurement of collaboration where the supplier always knows their score and how they’re trending. In this blog we outline five things to consider when creating a supplied scorecard.
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The Role Of Supply Agreements In Life Sciences Manufacturing
11/4/2021
In light of the disruption and the urgency around fast delivery of high-quality products, it makes sense that manufacturers and their suppliers might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners. Working with your supply partners to achieve their obligations starts with understanding your company’s existing supply agreements.
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How To Avoid Pharma’s Top 5 FDA Form 483 Triggers
10/13/2021
Explore the most commonly cited conditions that led to the issuance of Form 483s last year (summarized by the FDA's most recent 12-month inspection period) and tips for avoiding them.
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Ensuring Drug Accountability In Clinical Trials
10/1/2021
Pharmaceutical companies and regulators can’t be assured the results of the trial are accurate if there’s information missing from the drug accountability record. Ensuring proper drug accountability is far from simple. It requires forethought and consistency to be done properly.