Featured Articles
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21 CFR Part 11: 7 Ways To Avoid Noncompliance
12/20/2022
Explore the elements critical to 21 CFR Part 11 compliance, how they relate to noncompliance risks, and how a QMS software solution for life sciences simplifies the compliance process.
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MasterControl Raises $150M Series A Funding Round From Sixth Street Growth At Valuation Of $1.3B
12/19/2022
MasterControl, a leading provider of quality and manufacturing software solutions for the life sciences, announced its first ever funding, a $150 million Series A round led by Sixth Street Growth. MasterControl has grown profitably for nearly 30 years, and with this funding is valued at $1.3 billion. The proceeds will be used to accelerate the development of SaaS solutions serving the company’s global life sciences customers, which include Pfizer, Cochlear, Thermo Fisher Scientific and more than 1,100 others worldwide.
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Enabling Quality Executives To Spearhead Quality 4.0
12/14/2022
Quality 4.0 transformation has gained momentum over the last few years, and most companies are not seeing their expected results. Learn about an opportunity to change this ongoing pattern.
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Is Your QMS 21 CFR Part 11 Compliant?
12/5/2022
With many options for digital transformation in the quality software sector, there’s never been more opportunity to digitize your QMS. Explore the benefits of a digital QMS and more.
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What Are The Measurable Benefits Of Modern MES Software?
11/21/2022
Even a small amount of paper on the factory floor carries hidden costs in impeded throughput, productivity, and on-time shipment. Explore the benefits of a modern MES software solution.
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4 Essential Components Of An Audit Management System For Life Sciences
11/15/2022
The COVID-19 pandemic has changed audits and inspections. To combat these challenges, companies need to adopt an electronic quality management system that covers every aspect of audits and inspections.
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Continuous Improvement In Life Science Manufacturing
11/15/2022
Learn how having a 6S program tethered to a hierarchy of needs will provide safety for your team when introducing new lean manufacturing processes or continuous improvement software.
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6 Core Capabilities Your Digital DHR Must Have
11/14/2022
In medical technology manufacturing, organizations must maintain complete and accurate device history records (DHRs). For those manufacturers regulated by the U.S. Food and Drug Administration (FDA), the agency has made it clear. If the DHR doesn’t include complete information relating to the production and control of each lot or batch, the medtech manufacturer risks product quality issues or worse. Between 2017-2021, DHRs were among the top medical device warning letters issued by the FDA.
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Best Practices When Shifting From Paper To Digital Logbooks
11/10/2022
For companies developing regulated products, explore why everything that happens to equipment must be appropriately documented to maintain compliance with current good manufacturing practices (cGMP).
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How To Avoid Warning Letters For Data Integrity Nonconformances In Life Sciences
11/10/2022
Data integrity is established where the data is stored and managed in its original form. Discover why the FDA expects manufacturers to ensure all data meets the guidelines outlined in the ALCOA acronym.