Lab Computer Compliance Services

Help lab implement data integrity procedures and develop lab informatics:

• Comply with US-FDA 21 CFR Part 11 regulation. 

• Set up sharing policies for lab computers to make sure usage of lab computers are traceable and auditable.

• Lab informatic plan includes lab computer login privileges, scientific application privilege, raw data file backup and restore, system upgrades, and computer disaster recovery plans. 

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Lab Informatics Setup and Management

• Setup domain (intranet and internet), including guest internet setup and proxy management which would help blocking some websites.

• Installation, configuration and management of Active Directory Server to implement a centralized control for user privilege and data file sharing.

• Backup of raw data files and analysis data files to ensure concurrency control and access traceability. There are two flavors of data backup/archive plans available through the YTO Data Box:

  • the U-series focuses more on virus protection;

  • the W-series focuses more on the consistency of data files in terms of modified date and created date.  

• The hard drive image (bit-to-bit) copy on validated computers is very useful for GxP like-to-like change. It can replace a failed hard drive without a re-validation and/or change control. There won’t be any more re-installation of operating systems, scientific applications or any other configurations. Bit-to-bit copy helps save time and money.