Audit Trail SOP

By / Quality control / QC, SOP /

SOP for Audit Trail in Pharmaceuticals.

  • SOP covers below points:
    • Purpose of audit trail
    • Manual Integration procedure in HPLC system – software LAB SOLUTION
    • Creation of New Users in HPLC system – software LAB SOLUTION
    • Block of User login ID in HPLC system – software LAB SOLUTION
    • Project Creation in HPLC system – software LAB SOLUTION
    • Method Creation in HPLC system – software LAB SOLUTION
    • Audit Trail Verification
    • Auto Backup Verification
    • Privileges assigned to different users of HPLC system – software LAB SOLUTION
1.0 OBJECTIVE :
  • To lay down the procedure for allocation of rights at each user level, creation of new users and projects for HPLC analysis and procedure for usage of audit trail.
2.0 SCOPE :
  • This SOP is applicable for the all HPLC systems having LAB SOLUTION software in Quality Control Department.
3.0 RESPONSIBILITY :
  • Operator :
    • To follow the procedure for usage of audit trail
    • To take the audit trial printout after completion of each analysis
  • Method Developer :
    • To monitor and follow the procedure for usage of audit trail
    • To create new projects in the system
    • To ensure adherence and compliance of SOP
  • Reviewer :
    • To monitor and follow the procedure for usage of audit trail
    • To ensure adherence and compliance of SOP
  • Admin :
    • To create new projects in the system
    • To create new users and allocate rights based on level
4.0 ACCOUNTABILITY:
  • Quality Control Head
5.0 PROCEDURE :

5.1 The purpose of an audit trail is to make the electronic data secure and traceable. Audit trail shows in the record the name of persons who assessed the computer system with the date and time. It also helps to recover the lost data.

5.2 Audit trail assures the record integrity and security. It is a regulatory requirement.

5.3 Audit trail data is secured and do not have the option to edit or delete. In audit trail record, following information is recorded;

  • Name of user
  • Date and time
  • Name of person making change
  • Original and changed value
  • Reason for change made
  • Invalid attempts to log on the system are also recorded in the audit trail.

5.4 According to the 21 CFR part 11, a system having audit trail should include the following;

  • Audit trail records the changes made in electronic documents.
  • Records should be protected and ensure their accuracy and ready retrieval throughout the storage period.
  • Access to the system should be limited to the authorized persons only.
  • The system should record the date and time of used entries and action, modifications and deletion of records in the system. These records should show during the review of the system.

5.5 Four different access levels of HPLC users in LAB SOLUTION software,

  • User 1  :    Admin
  • User 2  :    Method Developer
  • User 3  :    Operator 
  • User 4  :    Reviewer

5.6 Privileges assigned to different users of HPLC system – software LAB SOLUTION as per annexure No. 01.

5.7 All users should have appropriate qualifications, level of access and defined responsibilities to carry out their assigned duties.

5.8 QC Head has rights of Administrator.

5.9 Manual integration for related substances shall be carried out in presence of method developer or reviewer only.

5.10 If required, manual integration other than related substances test will be carried out in consult with QC Head and it will be triggered though incident and investigated.

5.11 Administrator should not perform any analysis on HPLC system.

5.12 Method developer can perform HPLC analysis.

5.13 Manual Integration

  • Click on LAB Solution icon. A window of LAB solution will be appeared.
  • Enter User ID and Password and click on “OK”.
  • Select “Postrun” from side tools bar.
  • Click on “Select project”, “Select Project” window is opened. Select the project name related to product/ material and then click on “OK”.
  • Double click on ‘Postrun’.
  • A window of LAB solution Postrun analysis will be opened.
  • Click the “View” from main tool bar and select “Data Explorer”.
  • Click on “Data” tab from the four tab of Data, Method, Report format, Batch.
  • The following are two method of integration.
    • Integration procedure 1
      • Select the chromatogram and then select ‘Edit’ on Method view-Peak integration parameter window.
      • Click on integration tab and then on “Programme” icon.
      • Integration time programmed window is opened.
      • Change in width, slope, drift, T.DBL and min. area/ height as per requirement for integration of chromatogram.
      • Click on “Compound” on Method view compound table.
      • Add peak name in table and then click on peak, Retention time (RT) will be displayed in table.
      • Click on “Save” and then on “OK”.
      • Audit trail log- Input reason window is opened. Enter the specific reason and click on “Apply to all” tab, if required (for assay, dissolution, uniformity of content test only) and then click on “OK”.
      • LAB solution Authentication window is opened.
      • Enter the password and then click on “OK”.
    • Integration procedure 2
      • Click on “Compound Table Wizard” icon from the main menu.
      • Compound Table Wizard window is opened.
      • Click on “Programme”. A window of Integration Time Programme is opened.
      • Integrate the various peaks of the chromatogram as per specification.
      • Click on “Stimulate” tab and then click on “OK”.
      • Click on “Next” tab, second window of Compound Table Wizard is opened.
      • Select the integrated peaks and then click on “Next”.
      • Third window of Compound Table Wizard is opened. Click on “Next”.
      • Fourth window of Compound Table Wizard is opened. Click on “Next”.
      • Fifth window of Compound Table Wizard is opened.
      • Enter the selected peaks name and then click on “Finish”.
      • Click on “Save” and then on “OK”.
      • Audit trail log- Input reason window is opened. Enter the specific reason and click on “Apply to all” tab, if required (for assay, dissolution, uniformity of content test only) and then click on “OK”.
      • LAB solution Authentication window is opened.
      • Enter the password and then click on “OK”.
      • Other than the integration procedure mentioned, a few procedures are available for integration. Manual integration will be carried out by using various manual integration procedure which is comfortable to users.

5.14 Creation of New Users

  • Administrator has rights to create login and allocate the group as per the defined user level.
  • Double click on LAB Solution icon on desktop.
  • A window of LAB Solution will be appeared.
  • It will ask for Username and Password details for admin ,enter the details.
  • Enter User ID and Password and click on “OK”.
  • Click on “Administration” and then double click on “User Administration” folder. A window of “Administration tools/User Administration” is opened.
  • Click add “User Administration” icon. User Administration window appear.
  • Select on “Add” option, “Add User” window appear.
  • Enter the user ID, user name, password and select Rights groups from Groups list such as Method developer, Reviewer and Operator.
  • Click on “OK”.
  • Password should contains minimum 6 characters which contains alphabets, numbers and compleximetry symbols like ≠, @ ,$ .
  • Password age is 180 days.
  • Password will get locked after three successive wrong attempts.
  • User can recheck the login after 5 minutes from the time of unlock.

5.15 Block of User login ID

  • Double click on LAB Solution icon on desktop.
  • A window of LAB Solution will be appeared.
  • It will ask for Username and Password details for admin, enter the details.
  • Enter User ID and Password and click on “OK”.
  • Click on “Administration” and then double click on “User Administration” folder. A window of “Administration tools/User Administration” is opened.
  • Click add “User Administration” icon. User Administration window appear.
  • Select User ID and then click on “Edit”.
  • A window of “Edit user- System administration” is opened.
  • Click on “Disable account” and then click on “OK”.

5.16 Project Creation

  • Administrator, Method Developer and Reviewer have rights to create new project.
  • Double click on LAB Solution icon on desktop.
  • A window of LAB Solution will be appeared.
  • It will ask for Username and Password details for Admin/ Method Developer/ Reviewer, enter the details.
  • Enter User ID and Password and click on “OK”.
  • Click on “Administrator”, A window of “Administration tools” appear.
  • Double click on “Project Administration”. A window of “Project Administration” is opened.
  • Click on ‘add’, Project Creation Wizard window is opened.
  • Enter project name and comment.
  • Click on ‘Next’ until ‘Finish’ appear on window.
  • Select ‘Finish’, window will close.

5.17 Method Creation

  • Method developer and Reviewer have rights to create new method.
  • Double click on LAB Solution icon on desktop.
  • A window of LAB Solution will be appeared.
  • It will ask for Username and Password details of Method Developer/ Reviewer, enter the details.
  • Enter User ID and Password and click on “OK”.
  • Click on ‘Instrument’ and then click on ‘Select Project’. A window of “Select Project” is opened.
  • Select the product name and then click on “OK”.
  • Double click on Instrument ID. Real Time Analysis window appear.
  • Click on “File” of main menu bar and then select “New Method File” A window of “Method Editor (Instrument Parameters)” is opened.
  • Click on “Edit Instrument Parameter”. Set the parameters as per specification for analysis.
  • Give the name to method after parameter settings.
  • Click on “Download and Close”.

5.18 Audit Trail Verification

  • Audit trail shall be verified by reviewer after completion of each analysis.
  • Double click on LAB Solution icon on desktop.
  • A window of LAB Solution will be appeared.
  • It will ask for Username and Password details of Method Developer/ Reviewer, enter the details.
  • Click on Administration option and then click on Log Browser.
  • A window of Log Browser will be shown.
  • Select specific period by entering specific date interval, start and end time to select the specific time log.
  • Click on “Start” tap to show audit trail of specific audit time log.
  • Audit trail data is also selected by entering project name, user name, application name, event type, message, sub message.
  • After review of audit trail for each analysis, data is in system, it will print when required.

5.19 Auto Backup Verification

  • Click on ‘Computer’ on desktop.
  • Click on ‘Auto back up’.
  • Check the date of folder created automatically for verification.
  • Click the folder which is last folder created recently.
  • Three folders are shown which are as follows;
    • Lab solution
    • Sql
    • Results
  • Open “Lab solution” folder and ensure that 13 folders are available.
  • Open “Sql” folder and ensure that number of projects should not be less than the projects observed on previous day.
  • Open “Results” folder. Search (ctrl + F) for “Error”, and ensure that no error are found.
  • If any changes are observed in observation, inform to Service engineer.

5.20 If any hardware related issue observed during analysis, incident is raised and service engineer is called for further investigation and rectification. After rectification, entry is taken in usage log of respective system. The similar procedure is followed for AMC performed by service engineer.

 6.0 ABBREVIATIONS:
AbbreviationExpanded form
SOPStandard Operating Procedure
QAQuality Assurance
No.Number
HPLCHigh Performance Liquid Chromatography

7.0 ANNEXURES:
  Annex. No.Title
01Privileges assigned to different users of HPLC system – software LAB SOLUTION

8.0 SOP REFERENCES
  •  U.S. Food & Drug Administration, Code of federal Regulations tittle-21, Part-11 Electronic Records : Electronic Signatures.

END OF THE SOP

ANNEXURES :

Annex. No. 01 Privileges assigned to different users of HPLC system – software LAB SOLUTION