Angel Buendia
Knowledge Manager, Scilife
With 20+ years of experience shaping quality within pharmaceuticals, Ángel bridges QC & QA expertise in life sciences. His passion for continuous learning, combined with his role as a Smart Quality advocate, drives his dedication to instilling a quality culture, guiding teams with collaborative leadership, and fostering excellence as a cornerstone. He navigates complex regulations, and is driven by upholding high standards and fueling innovation.
More articles from Angel Buendia
If you’re here, chances are you’re considering, or already actively searching for, a knowledgeable life sciences consultant to help pave the way for your organization’s future growth. Maybe you need support achieving ISO 13485 certification, obtainin...
SharePoint has become an accidental QMS for many life sciences organizations. And look, we get it. It’s “free” (or at least already included in your Microsoft 365 subscription), it lets you build folder structures, and you can organize quality docume...
Pharma audits are not routine checks. They are moments of truth. Whether it’s an internal audit, a supplier audit, a customer audit, or a regulatory inspection, the question is always the same: Can you prove, with evidence, that your Quality Manageme...
Most people know the name of a medicine, but not the part that actually makes it work. That part is the active pharmaceutical ingredient (API), and in pharmaceutical manufacturing, its quality is everything.
If you work in medical devices in the EU, the question is no longer what EUDAMED is, but whether your data and ownership model will survive mandatory use.
Corrective and Preventive action (CAPA) sits at the core of every quality system in the life sciences. When a deviation appears, a complaint escalates, or an auditor asks an uncomfortable question, your CAPA process ultimately decides the outcome.
Any QA professional in life sciences who has ever prepared an annual product quality review knows how demanding it can be. What should be a structured quality exercise often turns into weeks of pulling information from everywhere—spreadsheets, emails...
Switching from paper to eQMS creates the perfect opportunity for QA teams to build on what already works and streamline what doesn’t.
Today, Good Laboratory Practices in the pharmaceutical industry remain the foundation of reliable science, ensuring that non-clinical data used for regulatory submissions is both credible and reproducible.
When your manufacturing line is running smoothly and your paperwork looks in order, you might think you’re “doing GMP”.
In my experience working with quality teams, GxP compliance in pharma is often perceived as a burden. However, it's a framework that protects what matters most to our industry: patients, product quality, and regulators' trust.
According to the EMA, Good Distribution Practices (GDP) comprise minimum standards that a wholesale distributor must meet to ensure that the right environment and handling are maintained throughout the supply chain to prevent any alteration of the me...
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