Industry Perspectives

1. How AI Is A Game-Changer For Auditing Compliance And Efficiency 4/9/2025

   In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

2. Struggling With GxP Systems? There's A DAP For That 4/2/2025

   A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

3. Risk Management Planning: Be Prepared When Disaster Strikes 4/1/2025

   Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.

4. The Future Of Medical Device Labeling Is Here 4/1/2025

   Medical device labels that lack information or contain inaccurate information may lead to product recalls or delays in product release. Generative AI offers a solution to streamline the labeling development process. 

5. Mastering EU MDR & IVDR: Certification Compliance For Medical Device Importers And Distributors 2/24/2025

   Article 16 of the European Union’s Medical Device Regulation and In Vitro Diagnostic Regulation specifically address the obligations of importers and distributors who engage in relabeling and repackaging activities.

    

6. 9 Reasons Why You Should Consider AI In Analytical Instrument Qualification 2/21/2025

   AI is about to completely change the analytical instrument qualification (AIQ) landscape in the pharma/biopharma and medical device industries.

7. Managing Contamination Risks In The Pharmaceutical And Medical Device Industries Using Relational Risk Analysis 2/18/2025

   Of all the risks associated with pharmaceuticals and medical devices, controlling contamination is one of the most important and difficult challenges. Relational risk analysis (ReRA) can help.

8. Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide 2/5/2025

   Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.

9. A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices 2/3/2025

   Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

10. These Were FDA's Top Citation Issues For Data Quality In 2024 1/31/2025

    Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.