Data Confidence

Data confidence underpins every stage of Method Lifecycle Management. Compliant-ready informatics systems, robust hardware, and informed procedures help ensure data quality and data integrity, facilitating well-informed decisions.

Data Confidence in Depth

App notes / Tech briefs
Highly Sensitive and Robust UPLC-MS/MS Quantification of Nitrosamine Impurities in Sartan and Ranitidine Drug Substances
Highly Sensitive and Robust UPLC-MS/MS Quantification of Nitrosamine Impurities in Sartan and Ranitidine Drug Substances

Demonstration of the highly sensitive and robust LC-MS/MS quantification for six nitrosamine impurities in solutions containing sartans and ranitidine drug substances. 

Blogs / Articles
Enhancing Controls in Impurity Analysis
Enhancing Controls in Impurity Analysis

Learn how to achieve the data quality and integrity necessary to drive correct decisions about pharmaceutical product safety and efficacy. 

eBook | Understanding Data Integrity in Your Laboratory Operations

This eBook is a collection of 6 articles covering several aspects of Data Integrity. The principles and strategies outlined can be leveraged to ensure Data Integrity across your laboratory operations.

Videos / Webinars
Waters Explains Data Integrity and Why it is Important

Validating analytical methods is critical to achieving accurate, consistent, and reliable results. There are multiple challenges during the validation process, from planning the analytical testing protocol, to the calculation of results and comparing against the acceptance criteria. This webinar will help you increase laboratory efficiency for chromatographic method validation, and ensure compliance to the validation requirements and acceptance criteria.

Data Integrity Compliance Infographic

What does compliance mean for your laboratory’s computerized systems? Review the compliance dos and don'ts, regulatory expectations, data lifecycle, and data risk assessment in this infographic.

Publications & Whitepapers
The Role of Empower 3 Chromatography Data Software in Assisting With Electronic Records Regulation Compliance

21 CFR Part 11 background and scope, Empower 3 is  designed to archive and catalog machine- and human-readable data; Electronic records def & app; Controls for closed systems; Accurate and complete copies; Protection and ready retrieval of records; Server-based enterprise solution; Automated backup of completed lab data; Device management; Limiting system access; Audit trails; Controls for open systems; Electronic signatures (def/applicability, components and controls, general requirements, manifestation, record linking, controls for ID codes/passwords.

Publications & Whitepapers
Why is Electronic CDS Data a Major Data Integrity Concern for Regulators?

This white paper describes how chromatography data systems address specific concerns and challenges when demonstrating data integrity to an auditor or regulator.

Understanding Data Integrity: Your Guide to Ensuring Confidence, Reliability, and Trust in Your People,Processes, and Data

This e-book covers: solutions for problems that surface in audits regarding CDS; how metrics collected as part of a data integrity plan can improve processes; and how automated archival solutions support the long-term endurance of data.