Waters data integrity solutions for your lab

Data integrity refers to the overall completeness, accuracy and consistency of data and processes during their entire life cycle. Though this seems simple, the whole process of generating, maintaining and transforming data with completeness and accuracy is a challenging task for any organisation.

Data integrity addresses the ‘life cycle of data’. This includes the steps involved in setting up and running the analyses, as well as managing the data that is collected, both raw chromatographic data, but more importantly through the cycle of processing, interpreting, reviewing, reporting and managing that data. So, it is not only a concern about how to store data, as the generation through analytical experiments is equally as important.

Laboratories need to have confidence in the quality of their results and the methods used to generate those results. Many customers use Waters’ consumables, instruments, software, and services in regulated environments. Waters experts have years of experience supporting these customers to ensure their laboratories meet regulatory expectations, such as Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs) and Good Clinical Practices (GCPs) from health authorities across the globe. Specifically, informatics specialists have developed expertise in the expectations regarding management of electronic data to meet those regulations, for example 21 CFR Part 11, EU Annex 11 and PIC/s Annex 11, plus regulatory and industry guidelines.

Electronic data and computerised systems introduce new challenges to maintaining data integrity. Waters chromatography systems and informatics software address these specific concerns and challenges when demonstrating data integrity to an auditor or regulator. Audit trails are considered the key to the security of a system since they track changes to data and metadata.

Waters’ Empower chromatography data software (CDS) platform assists with audit trails and logs, which are important to reviewers. Waters Compliance Services can simplify the process of qualification, validation and record-keeping so that your business can focus on delivering products to market.

MICROSEP (PTY) LTD Louis van Huyssteen Tel: (011) 553 2300 Fax: (011) 553 2400 louis.vanhuyssteen@microsep.co.za www.microsep.co.za