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…
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Learn how the BioAccord LC-MS System is instrumental in the drug development workflow from sample prep to reporting.
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.
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?
It’s not just about compliance any more. You’ve seen it in the headlines: 79% of Warning Letters issued by the FDA cite data integrity issues in 2016 (up from just 26% in 2013). But what does this actually mean? Where do these figures come from? Isn’t this just in India or China? What was traditionally…
In August 2014, the United States Pharmacopeia and the National Formulary (USP-NF) put into effect new guidelines to “allowable adjustments” in its Chapter <621> (USP37-NF32 S1). And as of August 1, 2016 when USP 39 NF 34 S1 goes into effect, for <621> nothing significant has changed since. The USP doesn’t publicize changes to their…
Compliance is required by every regulated industry and in nearly every nation. Whether it’s complying with strict regulations from the United States Food and Drug Administration, the European Directorate for Quality Medicines, or other regulators overseeing a wide range of industries, it’s every company’s responsibility to comply with the regulations and provide the data to…