Validation, Commissioning & Design Featured Articles
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Extending Quality Management Through Vendor Compliance Audits
5/25/2023
Explore the primary responsibilities of both manufacturers and vendors during a vendor compliance audit, as well as practical strategies and tools, including audit management software, that make them possible.
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Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing
5/24/2023
During my career as an executive in pharmaceutical manufacturing quality assurance, I have heard the term “cost of quality” (COQ) over and over when advocating for budget and resources. Most people think that it is just an excuse for higher costs, but that is not true. I'll share what is involved in calculating the COQ and why it's important.
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Set Up A Single Use System For Success
5/22/2023
Utilize a modern distributed control system and single-use systems to meet your organization's regulatory requirements, incorporate newer digital technologies and analytics, and lower the cost of ownership.
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Set Up A Single Use System For Success And Flexibility
5/22/2023
Achieve manufacturing operational flexibility, ease compliance, and get to market faster with modern distributed control systems and the incorporation of single-use systems.
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Can Life Sciences Untangle Tech Transfer?
5/19/2023
Explore the complexities of tech transfer, what is slowing tech transfer down on a commercial level, and the two-pathway approach you can take when adopting digital native tools.
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Embracing And Implementing Computer Software Assurance Guidance
5/18/2023
Pharmaceutical manufacturers are exploring comprehensive computer software assurance (CSA) approaches, the benefits of implementing a risk-based framework, when to apply it, and the first steps to this CSA approach.
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Assess Your Digital Pharmaceutical Manufacturing Maturity
5/18/2023
Learn how regulated product manufacturers are meeting the demand for faster development and delivery of products to patients and where your operations fit in the digital maturity manufacturing model.
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5 Steps To Pass Your ISO 9001 Audit
5/18/2023
Reduce your pre-audit stress and pave the way to successfully meeting ISO 9001 standards and becoming certified.
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Transitioning To Pharmaceutical Validation 4.0
5/16/2023
To help companies achieve Pharma 4.0, the International Society for Pharmaceutical Engineering is driving Validation 4.0 as a way to help organizations expedite the computer software validation process.
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Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials
5/12/2023
Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.