1.0 PURPOSE:
1.1 To lay down the procedure for security and access control of chromatographic software.
2.0 SCOPE:
2.1 This SOP is applicable for quality control department.
3.0 RESPONSIBILITY:
3.1 Executive – QC
4.0 ACCOUNTABILITY:
4.1 Manager – QC
5.0 PROCEDURE:
5.1 User types shall be defined in four levels
5.1.1 Administrator
5.1.2 Analyst
5.1.3 Reviewer
5.1.4 Guest.
5.2 Administrator level
5.2.1 The administrator level shall have access to all features of the software.
5.2.2 The administrator shall define the privileges of analyst, reviewer, and guest.
5.3 Analyst Level
5.3.1 Analyst level shall have an access to
5.3.1.1 Create instrument method.
5.3.1.2 Create and acquire the sample set.
5.3.1.3 Create and modify processing method.
5.4. Reviewer Level
5.4.1 Reviewer level shall have an access to
5.4.1.1 Create instrument method.
5.4.1.2 Create and acquire the sample set.
5.4.1.3 Create and modify processing method
5.4.1.4 Create new project.
5.4.1.5 Create and modify the report method.
5.5. Guest level
5.5.1 Administrator shall provide required privileges.
Modify processing, new project, privilegesv, guest, chromatographic