Quality assurance news and resources ǀ Inglasia Pharma Solutions

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Causes of Glass Particles in Injectable Medicines

The FDA published a recall notice in October 2024 for 1 lot of Ascorbic Acid Solution for Injection vials to the user level due to glass particles in vial. In some cases, glass particles can pass through the needle and may result in local irritation or swelling. The particulate matter could tr…

14 December 2025 Inglasia Pharma Solutions

Common CSV Documentation Requirements Explained

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Computerised systems play an essential role in regulated environments. Pharmaceutical manufacturers, biotech organisations, laboratories, medical device companies and clinical research teams rely on digital platforms to produce, store or process data that influences patient safety and product qu…

30 November 2025 Inglasia Pharma Solutions

Step-by-Step Process for Computer System Validation

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Regulated organisations depend on digital systems that must perform accurately, securely and consistently. When a computerised system influences product quality, patient safety or data integrity, it cannot simply be installed and used without controls. It must undergo a structured validation pro…

30 November 2025 Inglasia Pharma Solutions

CSV vs Software Qualification: What’s the Difference? A Clear Guide for Regulated Organisations

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Regulated industries depend on accurate, traceable and reliable digital systems. Pharmaceuticals, biotech companies, laboratories, medical device manufacturers and clinical organisations rely on software and computerised platforms to support processes that have a direct impact on patient safety,…

30 November 2025 Inglasia Pharma Solutions

Why Computer System Validation Services Are Essential for Compliance

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Quality leaders in regulated fields handle a heavy responsibility. Every digital system used in production, testing, storage, release, and distribution can influence patient safety and product quality. Any mistake inside these systems can place a company at risk of inspection findings, supply de…

30 November 2025 Inglasia Pharma Solutions

What Is Computer System Validation (CSV) in Pharma, and Why It Matters for Your Business

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Pharmaceutical manufacturers, biotech firms, and quality assurance teams in London face increasing pressure from regulators like the MHRA, EMA, and FDA to maintain strong control over computerized systems. Electronic systems, from LIMS and MES to document management and ERP platforms, play a cen…

30 November 2025 Inglasia Pharma Solutions

NEWS & RESOURCES

Causes of Glass Particles in Injectable Medicines

Common CSV Documentation Requirements Explained

Step-by-Step Process for Computer System Validation

CSV vs Software Qualification: What’s the Difference? A Clear Guide for Regulated Organisations

Why Computer System Validation Services Are Essential for Compliance

What Is Computer System Validation (CSV) in Pharma, and Why It Matters for Your Business

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