Performance and Compliance Simplified

Challenge: Maintaining data accuracy and integrity is critical to ensuring product quality and regulatory compliance. Manual data handling increases the risk of errors, making compliance difficult to achieve.

Our Solution: OsmoTECH osmometers automate data capture, ensuring precise, traceable measurements with secure storage and audit trails. This helps eliminate manual errors and ensures compliance with FDA 21 CFR Part 11 and pharmacopeia guidelines—protecting your data integrity at every stage.

Challenge: Strict regulatory standards like FDA 21 CFR Part 11 require secure, documented data and full audit trails. Preparing for audits can be time-consuming and prone to manual oversight.

Our Solution: OsmoTECH osmometers simplifies compliance with built-in audit trails, secure data management, and electronic signatures. By automating these processes, you reduce the effort and risk associated with preparing for regulatory inspections, ensuring peace of mind.

Challenge: Inefficient processes and testing delays can slow down your ability to bring products to market, impacting competitiveness and profitability.

Our Solution: OsmoTECH osmometers accelerate critical bioprocessing stages by delivering fast, reliable osmolality results. Automating testing workflows reduces bottlenecks, enabling quicker, more informed decisions, which ultimately shortens your time to market.

Challenge: Inconsistent osmolality measurements can negatively affect cell culture health, purification efficiency, and final product quality, leading to lower yields and increased variability.

Our Solution: With precise osmolality measurements at every step, OsmoTECH osmometers ensure optimal conditions for cell culture and purification processes, resulting in consistent product quality and improved yields throughout the bioprocess.

Challenge: Multiple instruments and workflows create complexity, increasing the potential for inefficiencies and miscommunication between systems.

Our Solution: OsmoTECH osmometers integrates smoothly with your existing lab systems, centralizing data management and simplifying operations. This streamlined approach reduces complexity and ensures seamless communication between different bioprocessing stages.