D-804
Data and Audit Trail Review in Agilent Open Labs Software
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1.0 Purpose
The purpose of this procedure is to define the process and criteria for reviewing audit trails in
Agilent Open Labs data collection software. This SOP also defines how electronic data is stored
and archived.
2.0 Scope
The procedure governs electronic data and audit trails created by Open Labs software used in the
Quality Control Laboratory.
3.0 Responsibility
3.1 It is the responsibility of QC analysts to ensure all generated data meet GMP
requirements.
3.2. Itis the responsibility of data review analysts or other qualified individuals to review data
and sign notebooks/electronic data and/or audit trails.
ce. It is the responsibility of QC Laboratory Management to keep this procedure current with
the latest Ion Labs Practices.
4.0 Definitions
4.1 Data Integrity — completeness, consistency, and accuracy of data
4.2 Audit Trail — a secure, computer-generated, time-stamped electronic record that allows
for reconstruction of the course of events relating to the creation, modification, or deletion
of an electronic record. Audit trails include those that track creation, modification, or
deletion of data (such as processing parameters and results) and those that track actions
at the record or system level (such as attempts to access the system or rename or delete a
file)
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4.3. Agilent OpenLabs Software — chromatographic data acquisition system (CDS)
5.0 References
>. 1 D-807, HPLC Operation Maintenance and Qualification
5.2. D-808, SOP, Use of OpenLab for HPLC and GC Data Acquisition and Reporting
6.0 OpenLabs Audit Trails and Electronic Data Review
6.1 OpenLabs Audit Trails are only to be reviewed by qualified personnel.
6.2 OpenLabs Audit Trails are to be reviewed for each analytical run, regardless of data
disposition.
6.3 OpenLabs Electronic records should be reviewed for all settings used to acquire data
along with settings for data processing.
6.3.1 Acquisition settings should be reviewed against the appropriate testing methods
to ensure all method settings were followed.
6.3.2 Settings used for data processing should be evaluated to ensure data integrity was
not compromised and no data was manipulated, i.e. are the integration events
justified.
6.3.3 Manually entered data such as dilution factors, sample weights, standard
concentrations, etc, should be evaluated against notebook write-ups for accuracy.
6.3.4 OpenLabs data reports should also be reviewed for accuracy prior to approving.
Figure 1 shows a sample summary report from Open Labs.
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Data and Audit Trail Review in Agilent OpenLabs Software D-804 3 of6
Figure / Example OpenLabs Data Report
on and 10a) Std RT Fearne sgl 13:09:38-05:00
Sequence HPLC#7-2022-01-07 13-09-S2y9-s0t5e-0m0 n e (RSof D5) 9a) Std Area
3 22AS002 STDA phenylephrine | 4.23 1220.79 DABIA Sge250 42.787200
4 22AS002 STDA phenylephrine 4.05 anes” [OY rs Aad 42.757200 ®&
$ 22AS002 STDA phenylephrine 4.02 1220.02 | OAD YSAign23-01 42.787200
6 22AS002 STDA phenylephrine 4.01 1217.81 , 13.0] 42757200
7 | __22asoa2 $TDA prensasteine | «00 | szieze aoe| 427572 19) Std concentration
Average 4.06 1219.17
RSD 0.101 i\
System Suitability (RoSf aDll)
injs | Sample Name Compouns | rt | ama | petoe| ~~ ta) Std wavelength
3 2248002 STDA phenylephrine 4.23 1220.79 42.757200
4 22A8002 STDA phenylephrine 4.05 1219.03 42.757200
5 22AS002 STDA phenylephrine 4.02 1220.02 42.787200
6 2248002 STDA phenylephnine 4.01 1217.81 42.757200
7 22A8002 STDA phenylephrine 4.00 1218.22 42.757200
— =t 1o219a.1 7 ¢ 3) Sys. Suit requirement
10a) Sample RT _ System Suita(SbTD iB tReicovteryy)
ina Sample Name Compound RT Area
8 2248002 STDB phenylephrin"e| 3.99 1269.38
9 22AS002 STDB phenylephrine | 3.99 1250.35 ) Sample weight/volume
: re Averaget 1259.37 6) Serving weight/volume
96) Sample area eee |
12 1 phenylephrine] 3.98 1147.15] ee aan 100% of | so20 | 40231 | 2.0 | 50.00 | § {1000.00
7 4) Spectral purity requirement
Notebook. Page Numbers).
7) Label Claim
ener _— 8) Final volume (includes dilutions)
Reviewed by: Date:
b) Sample wavelength
6.4 System Audit trails
6.4.1 <A “global” audit trail exists in the content management server. This collects
information on a broad scale such as:
6.4.1.1 System logins, opening of projects, creation of projects and other
global transactions
6.4.1.2 These can be accessed by logging in to the content management
system and clicking on “Activity Log.”
6.4.2. Method audit trails exist in the data analysis window of the open lab application.
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6.4.2.1 After opening the project and data set that is to be reviewed, click on
the Audit/E-Sign tab at the top of the page.
Home ff __s Processing
[= Show injection audittrait [ Show sequence audit trail i
if ? \ i
Ce Show result set audit trail
iiH
Audit Trails Lock Result
6.4.3 Result audit trails are mandatory and will always be included however
depending on the method set up parameters audit trails may include:
1. Injection audit trail
2. Sequence audit trail
34 Result audit trail
+ Method audit trails.
Processing Audit/E-Sign | Chromatograms
Show iryecvion audit trati eB Show sequence audit trait siigrnonan , i ‘4 £
&a
k
Show result set audit trail
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Audit tras ' Lock Results
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6.5 Reviewing audit trails
6.5.1 After loading the audit trail to be reviewed, click on the detailed view list.
Audit Trail Blank - 2022-07-08 14-23-58-04-00-01-r001.dx (Number of entries: 17)
==] Find From: : Mt Te:
+ Version New Sequence (5 entries}
+ LViemerrseiivosns 2O022-Y0704- siRyPaT tKSae
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6.5.2 Review audit trails by individually inspecting each entry, scrolling down to the
bottom of the list. Click review at the bottom of the list to notate the audit trail as
reviewed.
Audit Trail Blank - 2022-07-08 14-23-58-04-00-01-r001.dx (Number of entries: 17)
433
—- eee ee From) 7/8/2022 Ea") 1/9/2022 Fal Filtes
6.5.3. Audit trail review should include evaluation of what process occurred and the
rationale for each process.
6.5.4 Audit trails that are reviewed change from pink to gray.
7.0 Creating Projects, enabling audit Trails
7.1 Projects in the Open Lab software can be created by following these steps:
7.1.1 Open the control panel and navigate to the projects tab
7.1.2 Right click on the project icon and select create project
7.1.3. Alternatively, you can click on the create project icon on the top left hand corner
of the screen.
7.1.4 In properties, enter project name and desired project folder path. If desired, add
a description.
7.1.5 In CDS settings under audit trail settings, click the box next to “Allow users to
type in their own reason when saving”).
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7.1.6 In each sub-section in audit trail, click the boxes to enable audit trail and allow
users to type their own reasons when saving results
8.0 Archiving OpenLabs Data
8.1 Open Labs data will be archived at regular intervals, minimally every two years.
8.2 New Data Acquisition Projects should be created on an annual basis.
9.0 Revision History
| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 09/23/22 | New procedure. N/A J. Sassman Updated flow and section names of document for clarity l 01/16/25 Removed Form D-804-F1 CC-25-0021 M. Maples | - | - |