File Category

Number of documents

Involves the main content

Quality Manual

1

Quality Management Outline

Program Files

34

Document control procedures, personnel management procedures, standard substance management procedures, instrument and equipment management procedures, facility and environmental control procedures, as well as data control and information management procedures, among others.

Large-molecule ligand binding

9

Methodology validation, sample analysis, sample reanalysis, analytical method development, and biomarker method validation, among others.

Pharmacology Department

48

Numbering and marking of laboratory animals, handling and restraining experimental animals, drug administration to dogs, collection of blood samples from experimental animals, preparation of test substances, and more

BSL-2 Laboratory

43

BSL-2 laboratory waste management, personnel management and training, monitoring, testing, and maintenance of laboratory facilities and equipment, as well as biosafety measures for experimental activities, etc.

General Laboratory Management Categories

13

Business continuity, outlier removal, archive management, abbreviations, chromatographic column management and usage, and more

Quality Management Department Category

3

The Quality Management Department's review processes for projects, as well as the department's audits of the quality management system, among other activities.

Small-molecule bioanalytical chemicals

8

Validation of bioanalytical methodologies, analysis of biological samples, reanalysis of bioassay samples, chromatogram peak integration, and more

Instrument and Equipment Category

28

LC-MS/MS instrument operation and maintenance, electronic balance operation and maintenance, ELISA reader operation and maintenance, and more

Information Technology Category

11

Computerized system failures and disaster recovery, backup, archiving, and restoration of computerized systems, as well as the use and maintenance of Watson LIMS.