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.
The Stages of Method Lifecycle Management
Methods with greater agility, robustness, and capacity for change can help reduce regulatory burden, failure risk, and costs. Discover the stages, concepts, and terms that define lifecycle management, then explore them in depth below.
Data Confidence in Depth
Demonstration of the highly sensitive and robust LC-MS/MS quantification for six nitrosamine impurities in solutions containing sartans and ranitidine drug substances.
Learn how to achieve the data quality and integrity necessary to drive correct decisions about pharmaceutical product safety and efficacy.
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.
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.
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.
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.
This white paper describes how chromatography data systems address specific concerns and challenges when demonstrating data integrity to an auditor or regulator.
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.