Most AI projects fail. The organizations that succeed are the ones that build governance before they build velocity. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Artificial intelligence (AI) is poised to take routine work and shift it to fully automated workflows. Currently, 80% of AI projects fail.1 As with most paradigm-shifting technology, it…
Inspecting AI is not new to regulators. The expectations are already well-established. The key question is whether your organization can reliably demonstrate them. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Exploring artificial intelligence (AI) and machine learning (ML) in regulated laboratories governed by Current Good Manufacturing Practices (CGMP) may be new for your…
Why 2026 marks the shift from guidance to enforcement and what it means for your organization now. Written by Tracy Hibbs and Tony Sacchetti, Waters Corporation Regulators are already inspecting AI use, how prepared is your organization? For years, the pharmaceutical industry has anticipated regulatory clarity on the use of artificial intelligence (AI) and machine…
We are pleased to announce that Waters Corporation has successfully achieved SOC 2® Type II attestation for the waters_connect Cloud software platform, in accordance with the American Institute of Certified Public Accountants (AICPA) standards. This accomplishment reflects our unwavering commitment to safeguarding customer data, building trust, and upholding the highest standards of security, availability, and…
Ensuring the safety and quality of pharmaceutical products is a critical responsibility for manufacturers. The United States Pharmacopeia (USP) plays a pivotal role in setting the standards that safeguard patient health and uphold product efficacy. Among these, USP 789 specifically addresses particulate matter in ophthalmic solutions, emphasizing the importance of maintaining stringent quality controls to…
Combining BioAccord, our most capable MS detection platform, with ACQUITY Premier UPLC, our highest performance LC system, to demonstrate superior performance.
To ensure compliance success in a changing regulatory landscape, laboratories must continually adapt. Learn how the compliant-ready Waters BioAccord LC-MS platform helps biopharma address the additional compliance challenges posed by the field’s complex analytical instruments.
Learn how to bring increased confidence to your sample preparation workflows using automation, smart lab tools and electronic documentation from Waters. This blog post was revised in September 2023 to include the most up-to-date information.
Bring increased confidence in sample preparation workflows with OneLab, which enables you to track a lab analyst’s completion of an experiment. Read this blog post, revised in September 2023 to include the most up-to-date information, to learn more!
3 signs that you need to create a culture of compliance As mentioned in my first post on data integrity, people trust that companies create safe, quality products and rely on data to support that belief. But most product data, especially laboratory testing, should be designed to catch studies, batches, or test samples that fail…
What can happen when a laboratory doesn’t know that its electronic records leave a digital trace that the FDA can follow.
Behind analytical data are humans – with pressures, emotional and personal needs to provide the best possible data for the biggest impact, personal pride, or simply a desire to make their lives easier. Do human or cultural factors affect scientists in regulated laboratories or operators in manufacturing areas?