Page 69 - LC-SFC_Pharma_Brochure

Data Integrity

In recent years, as the FDA has become increasingly strict with compliance requirements, there are more and more
pharmaceutical companies that have received FDA warning letters. In response to increasingly diverse GMP/GLP security
control management requirements, as well as CSV, FDA 21 CFR Part 11 and other regulations and guidelines, the need for
laboratory equipment and analytical data management services has increased significantly. More accurate and efficient
implementation of multi-channel analysis operations, as well as the proper management of equipment and data, is the
current trend of the pharmaceutical industry.
In addition to a large number of chromatographic instruments, analytical laboratories use a wide variety of non-
chromatographic instruments. The secure management and integration of these instruments and their data poses a
challenge for laboratory managers.

Shimadzu’s complete data management system provides secured data, and a fully-integrated network and laboratory.
With Shimadzu’s system, pharmaceutical industries are well-equipped for this data-and technology-driven environment.

LabSolutions CS

Multi-instrument data registration
Connected with acquisition controller PC
LabSolutions Server with LabSolutions Manager

Balance TOC TA EDX
LC GC UV FTIR RF PPSQ Other vendors’
LC GC
GCMS SALD ICP AA
LCMS ICPMS

Lab/Office PC and Laptops
Remote
Control
iPad

Shimadzu’s unified data management platform
• LabSolutions CS allows seamless integration of labs and offices Security Database
with control commands, instrument monitors, and remote Validation
control via other client PCs on the network. System Management

• In addition to chromatographs, spectrometers and mass
spectrometers, instruments from other analytical manufacturers
can also be controlled and operated by LabSolutions CS, and all Electronic Network Resource
data can be managed in the integrated database.
Record Concept Sharing
Ideal for high efficiency and low risk

• With a unified platform established, you can accomplish
instrument control, account setting, data management, report Electronic Remote Remote
generation, all functions and operations more efficiently. Signature Access Control

• Powerful database management functions and security
strategies minimize the risk of data loss and malicious
tampering, and strictly follow data integrity management
requirements.