CSV (Computer System Validation)

Definition:
Documented evidence or challenging test to prove that computer functions are fit
for the intended use.

Scope:
A. Laboratory based Equipment Software validation

Required Feature in Software:

Software installed in Computer needs to comply the following criteria:

1. Security
a.
b.
c.
d.

Closed system (Local network system controlled by Square)

Individual login with user name & password
User Locked due Wrong login attempt
Password change after time interval

2. User privilege or SOD (Segregation of Duties)

a. Specific function need to be assigned to a specific user
b. Job functions will be at least three level:
I.
End user
II.
Supervisor
III.
Approver/Administrator

3. Audit Trail
Following data will be capture in Audit trail:
a. New Value and corresponding old value
b. Time stamp
c. User name who has change the value

4. Database & Search ability in Database

a. Data archiving
b. Data backup & Data retrieval

5. Digital Signature/ Electronic Signature

Digital signature will authenticate the data by users.

6. Data integrity
All complete relevant & authentic information (data) needs to be clearly
available with taking considerations of above 1 to 5 point.

Documented evidence preparation and execution:

1. Master Validation Plan

2. URS preparation
3. FRS (Functional Requirement Specification) preparation
4. GxP assessment Form preparation
5. FRA (Functional Risk Assessment) preparation
6. IQ preparation & execution
7. Network Qualification & execution
8. OQ preparation & execution
9. PQ preparation & execution
10.
VSR (Validation Summary Report) preparation
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How this training will help us:

1. Lab based computer system validation will be performed without the
help of third party consultant that will help financially
2. Make us confident enough to perform the lab based computer
system Validation to meet the emerging complex regulatory
requirement as per 21 CFR part 11, EU, ICH and PIC/S
3. Risk based Approach to Laboratory Computerized Systems as per
GAMP5 will be realized
4. Software categorization will be clearly understood.
5. We can easily convince regulatory Auditors concerning this matter
6. It will help us to avoid FDA Warning Letters or other regulatory
bodys observation
7. Validation (Documented evidence mentioned in above ) preparation
will be performed properly
8. It will help us to handle CCR, periodic review, revalidation of lab
based computerized system properly
9. It will help us to produce SOP relevant to lab based computer system
validation like disaster management (Business continuity), data
retention period, access control & user management etc.
10.Importance and focus on Laboratory based Computer System
validation will be taken into consideration by the higher
management.