S. No.

Requirement

Yes/In progress

Organization and Laboratory Personnel

1

Does an organizational chart exist for CBA?

Yes

2

Is there a training and evaluation plan for all personnel aligned to the job description?

Yes

3

Have personnel received health/safety training?

Yes

4

Is there a process to report incidents and deviations?

In progress

5

Are external Vendors qualified before engagement?

Yes

Quality Assurance Program

6

Is there a Quality Assurance Unit?

Yes

7

Is the Quality Assurance Unit independent from the personnel engaged in the study?

Yes

8

Does the Quality Assurance Unit perform audits and report the results to the Laboratory Management?

In progress

Standard Operating Procedures

9

Is there a current index listing of the SOPs available?

Yes

10

Is there a schedule for review of the SOPs?

Yes

11

Are the SOPs in locations where they are used?

Yes

12

Are there SOPs for reporting deviations and CAPAs?

Yes

13

Is there a change control system for SOP/methods?

Yes

Facility

14

Is the access control to the facility?

Yes

15

Is there sufficient segregation between areas marked for storage of chemicals, archiving records, equipment, and sample preparation?

Yes

16

Is there a system to code test samples and reference samples and prevent cross contamination?

Yes

17

Is there safety equipment (e.g., showers, eyewash stations) available? Is the safety equipment maintained?

Yes

18

Are there environmental controls within the laboratory and are the controls monitored?

Yes

19

Is there a power back up provision at the facility?

Yes

Equipment

20

Are the equipment uniquely identified with a defined identification number?

Yes

21

Are the equipment manuals and SOPs available for ready reference?

Yes

22

Are there log books for each equipment that  include a chronological record of use?

Yes

23

Equipment calibration and/or preventative maintenance schedules have been established and are being followed and documented

In Progress

24

Is system access limited to authorized individuals only?

Yes

Documentation

25

Are Good Documentation Practices followed?

Yes

26

Is raw data recorded in lab notebooks or electronically and is controlled?

Yes

27

Is there a SOP that outlines the content of the final report?

Yes

28

Is there a dedicated facility/area for the archival of records?

Yes

Is there a method of electronic data archive?

In progress

Samples/Reagents/Chemicals/ Methods Control

29

Is the sample receipt area maintained separate from the sample processing area?

Yes

30

Is there an SOP that outlines how reagents are labelled, how expiration dates are established?

Yes

31

Are there validated methods and acceptance criteria for each test method?

In progress

Computer Systems

32

Are changes to computer systems controlled and documented?

In progress

33

Are records of hardware maintenance and repairs maintained?

Yes

34

Are computers backed up routinely to prevent loss of data? Is there a backup log?

Yes

35

Are there a computer validation master plan and/or SOPs?

In progress