For more than a century, microbial quality control (QC) has been a manual process of counting cultures and transcribing data to secondary data systems. It is an error-prone process that can compromise the integrity of results and the security of both data and samples.
Critical to effective, efficient, compliant microbial QC are data integrity and security. Depend on Growth Direct™ to ensure both.
Growth Direct optimizes data integrity in four key ways:
By maintaining accurate, complete, and intact records within their original context, Growth Direct ensures the trustworthiness of data. Plus, data reside in permanent form for the lifetime of the record, easily accessible to authorized users. This allows microbiologists to analyze trends over time for timely, cost-saving decision-making.
Most data and sample security issues result from manual operations lacking the necessary robust processes and controls.
Growth Direct streamlines processes and maximizes control. It also helps securely protect samples.
Traditionally, QC personnel have had to walk samples across massive pharmaceutical campuses and suit up before entering clean rooms. Growth Direct can be located at the production site, and samples can be analyzed in the production area. This enhances both security and efficiency.
Once loaded into Growth Direct, uniquely labeled cassettes are protected by an authorized access system with an audit trail.
User-friendly, secure software designed to comply to 21 CFR PART 11 features an intuitive interface to produce an easy-to-follow audit trail. Only authorized users can print or transmit data, and these actions are tracked and reported. Plus, automation ensures the comprehensiveness of data and timeliness of reporting.
By reducing manual steps and the inevitable human error, automated microbial testing with the Growth Direct maximizes data integrity, data security, and sample security.