Pharmaceutical companies must comply with numerous regulations. On August 20 1997, 21 CFR Part 11, Electronic Records and Electronic Signatures, was promulgated by the U.S. Food and Drug Administration (FDA). Its purpose is to allow regulated companies to submit documents to the FDA in electronic form in place of paper. The regulation requirements are to ensure the security and integrity of the electronic records and to ensure the electronic signature is treated with the same level of importance as the handwritten signature.
Functionality- One-window, quantitation environment features a step-by-step workflow process for easy data acquisition and review
- Perform method development, data review, processing, reporting, and data export
- Import sequence information from external systems
Data Storage and Access
- Safely process data stored on network-based computing systems, including secure remote disks
- Workbook-style, centralized file location that ensures easy data archiving and retrieval of relevant project files
- Multi-level security access; configurable user privileges from full system access to data review only
- Secure, digital, bi-directional interface with Thermo Scientific Watson Laboratory Information Management System (LIMS), a highly specialized protocol-driven solution that supports bioanalytical studies in drug development
Compliance: 21 CFR part 11
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