Data Audit Trail

Presentation

Wayahead Systems

www.wayaheadsystems.com
 Audit Trail System
OVERVIEW - in 10 steps
1. Why an Audit Trail System is essential?
2. What should be audited?
3. Mechanism of Audit Trail System
4. Create triggers for Audit Trail system
5. Login to the AuditingViewer program
6. Select date range
7. View audit trails
8. Report audit trails
9. Backup and Review audit trails
10. Validation of the Audit Trail system
1. Why an Audit Trail is essential?

1.1 Industry GAMP Guides, such as FDA CHAPTER 21, PART 11,
requires a Audit Trail System which is:

• Secure
• Computer-generated
• Available for review and copying to use offsite
• Audit all UPDATE, DELETE or INSERT for all record
changes with before & after details
• Retain historical audit of all changes
1. Why an Audit Trail is essential?

1.2 Backward audit for unexpected events

• Records modified by accident

• Missing records
• Wrong operations
• Database is hacked
2. What should be audited?
A. Table ID (Table name within the database)
B. Action (User can add, change, delete data)
C. Date & Time (When was the data changed)
D. User ID (Person who changed the data)
E. Workstation (Location of the User)
F. Program (Application opened by the User)
G. Reason (Why was the data changed)
H. Data values (Before & After each change)
3. Mechanism of Audit Trail System
3WS Database
(Oracle or MSSQL)

RECORD_AUDITING

TRIGGERS

USERS, etc...
3WS Tables

LOTNOS

4. Audit Trail updated

BATCH

Database operation
3. Trigger Activated
(UPDATE, INSERT, DELETE)

Wayahead Applications
2. Database Activity
External Applications

3WS

MPQuery
Interfaces

MFG43WS
DBMigration SQLPLUSW

Access Link
Query Analyzer
1. Program Activity
3. Mechanism of Audit Trail System
Computer- Secure
generated
• Triggers are special procedures inside the Database
 A trigger is automatically executed each time a record is
created, updated or deleted, and is managed within the
database
 Any database operations from Wayahead applications,
external applications or even hacking are always
recorded by the database triggers.
• An Auditing Viewer utility is then used to view Audit Trail
4. Creating triggers are simple

• For Oracle
 Run GRANT.bat
 Then run Create_Record_Auditing.bat

• For MSSQL
 Run Create_Record_Auditing.bat

NOTE: These are Wayahead supplied procedures and

would be managed onsite with your IT group present.
5. Login to the Auditing Viewer

Secure

Authorised users can access the Auditing

Viewer utility inside the 3WS main menu.
5. Login to the Auditing Viewer

Secure

Authorised users must login to the Auditing

Viewer utility, with an eSignature.
Management of eSignatures within 3WS, will
always generate data on the data audit trail.
6. Select date range to review audit
7. View Audit Trails
A. Table ID D. User
ID

B. F. Program
Action E. Workstation
C. Date
& Time

G. Reason
The reason can be determined by the
Program, Action and TableID, plus the Field name
fields which were changed. & data
7. View Audit Trails
Click column
header to sort

Press F2
Press F3 to
to search
search again
8. Report Audit Trails

Various report formats

are available.
View Audit Trails
Extra Search Conditions are allowed

You can
modify the
search
conditions
View Audit Trails
Display reflects the Search Conditions

The list of records

displayed will match
the search
conditions
9. Backup and Review Audit Trails

The external
D/B is available
for copy &
review

This creates an external database called

“AuditTrail.mdb”, which can be copied &
reviewed by the AuditingViewer utility.
9. Backup and Review Audit Trails
ARCHIVING OLD DATA

The Site
administrator
can nominate
the date range
for archives

An archiving feature is available to:

- create a backup of nominated date ranges
- create a zipped copy of the archived data
- delete this data from the main database
 10. Validation of the Audit Trail
• As part of site GMP considerations, the introduction
and management of the Audit Trail, must be validated.
• IQ includes database triggers creation in the database.
• OQ includes testing the creation of Audit records.
• OQ includes testing of Audit Trail review program.
• OQ includes testing of Audit Trail export procedure.
• Once the Audit Trail is validated, audit data can be used
in Test Results for other ‘standard’ 3WS testing scripts.
 10. Example Validation Test Script
ACME Mfg Coy

1) Record the date when the test started.

2) Log on 3WS and access the Lot Maintenance program.
3) Create a new LotNo record by clicking the New button & enter details into the new LotNo.
record or download a LotNo record through INT002W. Then save the new LotNo record.
4) CHANGE the LotNo record created in Method #3 by clicking the Change button in the
Lot Maintenance > Listing tab screen. Then save the changes made in the LotNo record.
5) DELETE the LotNo record created in Method #3 by clicking the Delete button in the
Lot Maintenance > Listing tab screen.
6) Access the Auditing Viewer program, logon as an authorized user and select the date range
to be the same as Expected Results #1 and then click the "Show Auditing Data" button.
7) Confirm that there exists three (3) audit trail record actions of INSERT (create), UPDATE
(change) & DELETE (delete) on the LotNo record executed in Methods 3 to 5.

Test sequence above: (3) Add a NEW record, (4) CHANGE the same
record, then (5) DELETE the record and (7) print the Audit Trail records.
Minimal data creation (new data)
Access the Lotno program – ADD a new Lotno record

A new record is a database INSERT action

Minimal Data creation in the Audit Trail
Audit Trail shows ONE record for the INSERT activity:

INSERT record only has one data Column

(not the Before & After columns).
Minimal data change (updated data)
Access the Lotno program – PRINT a barcode label

A change to a record is a database UPDATE action

Minimal Data creation in the Audit Trail
Audit Trail shows ONE record for the UPDATE activity:

UPDATE records have TWO data Columns

(with the Before & After data content).
Complex data change (multiple updated records)
Access the Dispensing program – complete a weighing, print a
barcoded Dispensing label, then update a Process Order

Changes to many records in the Audit database, plus

INSERT of the weighing activity and then label printing.
Complex Data creation in the Audit Trail
Audit Trail shows MANY records for the updates to the
Process Order and Lotno activities:
After a Dispensing activity a number of database table are updated:
BATCHWTS a new record INSERT to record the weighing data
BATCHITM to record that the Batch Item was fully weighed
BATCH to record Batch Expiry Date (earliest Lot Expiry
Date in this Process Order, used during MFG)
LOTNOS to record the weight used
WEIGHTUSED is updated from 0 to 120.000 gm
BATCHWTS updated to reflect the actual print of the barcode label
Many separate audit trail records – useful for system analysis / debugging

UPDATE records have TWO data Columns

(with the Before & After data content).
Conclusion
Audit Trail System must be: Audit Trail System audits:

 Secure & automatic  Table ID

 Action
 Computer-generated
 Date and Time
 Available for review
 User ID
and copying
 Workstation
 UPDATE, DELETE
& INSERT all changes  Program
 Retain historical audit  Reason
of all changes
 Before & After data
 Data Audit Trail

Presentation

Wayahead Systems

www.wayaheadsystems.com

john.nesbitt@wayaheadsystems.com
 The following slides are not part of the presentation.
These pages are an example of a validation Test Result
for Chapter 50 Test No 120, which was mentioned earlier.
Chapter 50 Test No 120 - Reference B
Chapter 50 Test No 120 - Reference C
Chapter 50 Test No 120 - Reference D
Chapter 50 Test No 120 - Reference E
Chapter 50 Test No 120 - Reference F
Chapter 50 Test No 120 - Reference G
Chapter 50 Test No 120 - Reference H
Chapter 50 Test No 120 - Reference I