ResourceGeneral Lab

Data integrity: Weighing in a regulated environment

Pharma-compliant lab balance systems for the highest standards in data safety and traceability

10 Oct 2019

Weighing in a highly regulated environment can be challenging, with stringent compliance directives and controls that must be met to ensure data safety and traceability, whilst delivering accurate and reliable results.

Violation of data integrity standards can not only impact decision making but could also have serious consequences for human health and safety. In fact, concerns on improper data integrity processes were the major reason for Food and Drug Administration (FDA) regulator actions in recent years.

In this application-based eBook, we look at how the adaptable, high-performance Cubis® II balance series from Sartorius helps to meet the ever-demanding regulatory needs of the pharmaceutical industry with end-to-end data integrity and regulatory compliance, and cover:

  • Data handling and integrity
  • Traceability and compliance
  • Digital documentation
  • Integrated informatics

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Balances and Moisture AnalyzersBalances & Moisture Analyzers / weighing scales measure static or dynamic loads. Features to consider when choosing an analytical balance include accuracy, capacity and resolution. Additional features and specialized balances include enclosures for weighing powder, microbalances for measuring small quantities, portable balances, moisture analyzers, top loading balances and internal calibration for measurements over time or with varied temperature.Sample ManagementSample management systems include sample storage devices such as freezers and plate storers, sample environment enclosures and sample organization, retrieval and sorter systems. Useful system features include high-throughput, automation, robotic arms, automated liquid handling and associated database systems. Accessories in sample management include barcode scanners, heat sealers and tubes.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Data LoggingData ManagementPharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.