lean-q database instruction manual - gmpsop · version: 1.0 2011 prepared by: lean-q ... existing...

Version: 1.02011

Prepared By: Lean-Q Soft®

Lean-Q DatabaseInstruction Manual

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Copyright©www.gmpsop.com. All rights reservedUnauthorized distribution prohibited

Copyright©www.gmpsop.com All rights reservedUnauthorized distribution prohibited

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The following manual was prepared to guide the users to demonstrate the overall function of the Lean-Qsystems. For this demonstration we have chosen one of the databases (Deviation Management Database) fromthe list. Although, all Lean-Q databases such as Product Complaint Management, Non ConformanceManagement, Change Control Management or Out of Specification Management are designed and developedunder the same principle.

If you would find the Deviation Management Database is easy enough to work with, So will others.

Let’s begin the manual starting with the Log in page of the Deviation Database.

Lesson 1: User and Administrator Log In

1.1 Starting with the Log In page

1.2 How to change the Administrator password

Administrator:The database Administrators need to create newuser to begin the operation. By default the Adminpassword is set as ‘newuser’. Admin should changethe password the first time database is accessed.Admin also has the privilege to delete a record ifraised by mistake or found duplicate.

Standard:All users other than the Administrator should accessthe database through the Standard button. Standardusers can only access the system if Admin will createa user profile for them in the system.

Exit:The Exit button will quit the program.

Admin can either access the database using the defaultpassword ‘newuser’. Or change the password byclicking the button “CHANGE PASSWORD”.

A change password window will open like below.


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1.3 How to add new user profile

1.4 How to Edit an user profile

On the new window Admin must enter the defaultpassword as the OLD Password, then enter a newcustomized password and verify the new password.

DONE. The default password will be changed. .

Admin can add as many new users asrequired at different times. To add a userAdmin must click the “EDIT/ADD USERS”button. This button is only visible on theHOME PAGE when logged in as anAdministrator.

Click the “NEW USER” button. On the newuser page enter the user name, positionand a password. Then click ADD. The newuser will be created.

User can change their password the firsttime they will log in the database.

Admin can change the user profile from theUser List as shown on the screen shot.

Click on the user name whose profile needto be changed.

The User Detail page will open for thatuser. Change the profile and click ADDagain. The profile will be changed.

Admin will notify the user about thechange.


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1.5 User Login to Database

1.6 How to change the User password

User can change the default password intotheir customized password by clicking the“RESET PASSWORD” button on the user login page. See the picture above.

A new window will open to reset the userpassword.

User can select their name, enter the oldpassword created by the Admin, enter newpassword, verify the new password and click“RESET” button.

DONE. User password will be changed.

As soon as the Administrator will create theuser profile and notify, the user can login thedatabase by entering the user name andpassword created by the Admin.

All users should access the system throughStandard button on the Log In page.

User can select their name and enter thepassword to log in.

Note:Administrator and User can change their passwords as many times as they like. The system canremember the changes. It is a good practice to change the password after a certain period of use.

In the case of user forget their password, they should notify the Administrator. Admin can edit the userprofile and send the new password to the user. User can change the password as demonstrated.


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Lesson 2: Database Home Page

Forms and Reports panels:Each database home page has two sections. All form buttons are listed on the left panel of the database and thereports are listed on the right.

New or Existing Record:User can raise a new deviation record by clicking “RAISE NEW DEVIATION” button OR continue to work on theexisting incomplete record by clicking the “EDIT EXISTING DEVIATION” button and selecting the record from therecord list.

New or Existing Corrective Actions:User can raise a new corrective action records associate to a deviation record by clicking “RAISE CORRECTIVEACTION” button OR continue to work on the existing incomplete corrective action record by clicking the “EDITEXISTING LIST” button and selecting the record from the record list.

User can raise more than one corrective action for a single deviation record.

Reports:The Deviation Management module can generate eleven useful reports from the existing deviation investigation data.All reports are system generated and user can rely on the accuracy of the reports.

User may want to see a full and completed deviation record and save it local drive. The Audit Trail report willprovide exact record history which can be used for record audit purpose.

User may like to know how many actions are raised for a deviation investigation and keep track of their closure.The system can raise records like number of deviations raised for a specified time; deviation raised per lotnumber; deviations raised by category; deviations raised for an equipment, facility or utility; deviations raisedper processing lines; deviations raised per Product or raw materials; Etc.

All reports raised by the Lean-Q system can be saved as a pdf file into user’s local hard drive. User can also printthose reports directly from the system.


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2.1 Raise a new Deviation investigation record

Click on “RAISE A NEW DEVIATION” button on thehome page. This will open the Deviation Form like thepicture below.

User can also raise new blank deviation form at differentstages of a record by clicking the button “RAISE NEWDEVIATION” button.

Now start by entering the deviation information on the form as labeled. Such as, user enters the date deviationoccurred; deviation category; processing line/s involved; Products / Raw Materials / Components affected; AffectedLot/s; quantity involved in the incident or deviation; department / Area affected, deviation from the controlleddocuments or specification; facility / utility or instrument name and code where the deviation occurred; manufactureror supplier name if necessary, etc.

Entering the deviation parameters depend on the extent of the incident. If some parameters are not required for thedeviation record, enter or select “Not Applicable” for the field.

Entering or selecting parameters are easy. As soon as a new parameter detail is entered, the system saves it in a listand shows those on the list next time. So, users do not have to enter the same parameter again. They can select itas needed.

This is explained below.


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2.2 Add a new parameter, Edit or Delete as required

New Button:

Picture 1:

Picture 2:

Edit Button:

User can add a new parameter or edit or delete an existingparameter using the set of buttons “Edit – New – Delete”.

NEW button will open a window like picture 1 below. Users need to add a new Product or Raw material orComponent which is not already listed using the NEW button.

Enter the Product / Raw Materials name and code, click OK. The product or raw material will be added in the list.User can now select the added product or raw material from drop down box as shown in the picture 2.

Users can edit a wrong entry or delete an entry permanently from the list by going to EDIT button. User selects theincorrect entry and clicks the EDIT button. As the product window opens (like picture 3), user can correct the productname or code and then click OK. The corrected product name will appear in the list.

If an entry needs to be deleted from the list permanently, user can do so by clicking the EDIT button again. A warningmessage will appear for the delete action.

Caution: Editing or deleting an entry might interfere with the system’s reporting. If an entry will be deletedpermanently before a record being completed, the deleted entry won’t appear on the record.


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Picture 3:

Delete Button:

2.3 Choose the Responsible person and Sign the record electronically

Spell Check:

The delete button on the deviation form will temporarily delete the entry from the record, but not from theparameter list. To delete an entry from the list permanently, follow the EDIT button procedure as describedearlier.

As the deviation title and description of the incident are entered, user can select the appropriate“RESPONSIBLE PERSON” from the existing user list. The Responsible person would be one who willcoordinate the investigation to complete and the most suitable person for conducting the investigation.

User can check the spelling of their text entries anytime by clicking the Spell Check icon.


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2.4 Electronic Signatures

2.5 A Saved record is locked from editing

2.6 How to edit a saved record

As the user completes all the relevant entries, an electronic signature needs to perform on the record and thenSAVE the record.

To make an electronic signature, user will select the name from the list. User’s position, Date and time willautomatically populate on the form. Next, user has to write a short comment and click on the SAVE button.

As soon as the user click on the SAVE button, all entries will be locked. No one can change the savedinformation until the user will sign again to initiate a change on the record.

In order to change a saved record, user has toselect the section of the investigation formwhere the possible change will be made. Likethe picture on the left.

Then Click the SUBMIT button. A new changemanagement window will open as below.

The record ID, Date and time of the change willappear on the window automatically.

User will select their name and write brief reasonfor change and click SUBMIT again.

This will UNLOCK the saved record and usercan make the changes on the record.

After the edits will be made, user will save therecord which will LOCK the entries again.

All changes made on the record will appear onthe record’s AUDIT TRAIL report with real timeand date stamping.


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2.7 Edit an existing deviation record

Picture 1:

Picture 2:

2.8 Complete the deviation assessment and investigation

User can edit an existing record by clicking on the button “EDIT EXISTING DEVIATION”. This will open a pagewith the Existing Deviation list. See picture 1 below.

Click on the selected record number and the relevant record will open for editing.

User can also specify the record number from the SEARCH window and click on the search icon. The selectedrecord will open. See in picture 2 below.

Picture 1 below shows how the deviation assessment has to be done. At the end of the assessment the assessorhas to sign the assessment in the way described earlier.

Picture 2 shows how the deviation investigation information has been entered and saved. The person completedthe investigation has to sign at the bottom of the investigation and save the entries.


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Picture 1:

Picture 2:


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2.9 Add attachments into record

2.10 Raise Corrective actions in association with the record

User can insert relevant attachments within the record. Any type of file supported by Windows program such asword, excel, jpeg, pdf, etc. can be attached in the record if required.

To attach a file click ADD. The browser window will open from where user can select the file to attach.

To view the attached file, click on the VIEW button. The attached file will open in a separate window.

To delete an attachment, just select the file and click DELETE button. The file will be deleted from the list

User can raise corrective actions in one of the two ways. To raise a corrective action click on the “RAISE ACTION”button inside the deviation record. This will open the Corrective action window like the picture below. System willrecognize the deviation record number and raise a corrective action in association with the deviation number.

The default action number format has a prefix of first three capital letter of the module followed by the next availablesequential number starting from 10001. For example, the first action number for the deviation module will beDEV10001. User can generate as many corrective actions for a given deviation number as required.

User can also raise corrective action separately for any deviation number by selecting the “RAISE CORRECTIVEACTION” button on the HOME PAGE. In such case, user can manually select the deviation number from the dropdown list.


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2.11 Review and Approve a Deviation record

As the investigation will complete successfully, the management level user can review and approve the record,make appropriate changes through the record change management process. User will sign electronically for theirreview and approval actions.


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Lesson 3: Generating Reports from the Database

3.1 Preview Deviation Report:

3.2 Audit Trail Report:

3.3 Preview Actions:

User can generate a complete a Deviation record by clicking on the “PREVIEW DEVIATION” button. User to selecta deviation number from the drop down list and click SUBMIT to open the report.

User can generate a complete a Deviation Record History by clicking on the “AUDIT TRAIL” button. User to selecta deviation number from the drop down list and click SUBMIT to open the report.

(Click here to see a system generated Deviation Preview report)

(Click here to see a system generated Audit Trail report)

User can generate a corrective action preview report by clicking on the “PREVIEW ACTIONS” button. User toselect a deviation number from the drop down list, then to select the action number and click SUBMIT to generatethe report.

(Click here to see a system generated Action report)

http://gmpsop.homestead.com/accesss/samplereports/DEVIATION.pdf

http://gmpsop.homestead.com/accesss/samplereports/Audit_Trail_10002.pdf

http://gmpsop.homestead.com/accesss/samplereports/Deviation_action_DEV10002.pdf


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3.4 List of Actions by Deviation Report:

3.5 List of All Deviation Report:

3.6 List of Deviations by Time Range Report:

(Click here to see a system generated list of actions/deviation report)

User can generate a list of deviation raised within a time range by clicking on the “DEVIATION BY TIME RANGE”button. User to specify a start date and an end date for the report and click SUBMIT to generate the report.

(Click here to see a system generated sample report for all deviations)

(Click here to see a system generated deviation/time range report)

User can generate the list of actions raised in association of a Deviation by clicking on the “LIST OF ACTIONS BYDEVIATION” button. User to select a deviation number from the drop down list and click SUBMIT to open thereport.

User can generate the list of all Deviations raised by clicking on the “LIST OF ALL DEVIATIONS” button.

http://gmpsop.homestead.com/accesss/samplereports/List_of_action_by_Deviation.pdf

http://gmpsop.homestead.com/accesss/samplereports/List_of_all_deviations.pdf

http://gmpsop.homestead.com/accesss/samplereports/Deviation_by_time_range.pdf


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3.7 List of Deviations by Processing Line Report:

3.8 List of Deviations by Lot Number Report:

(Click here to see a report for deviations by processing line)

User can generate a list of deviation raised per Processing Line within a time range by clicking on the “DEVIATIONBY PROCESSING LINE” button. User to specify a processing line, a start date and an end date for the report andclick SUBMIT to generate the report.

(Click here to see a report for deviations by lot number)

User can generate a list of deviation raised for a lot number report by clicking on the “DEVIATION BY LOTNUMBER” button. User to select a lot number from the drop down list and click SUBMIT to generate the report.

http://gmpsop.homestead.com/accesss/samplereports/Deviation_by_processing_line.pdf

http://gmpsop.homestead.com/accesss/samplereports/Deviation_by_lot_number.pdf


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3.9 List of Deviations by Category Report:

3.10 List of Deviations by Facility/Utility/Equipment Report:

3.11 List of Deviations by Product/Raw Material/Component Report:

(Click here to see a sample report for deviations by category)

User can generate a list of deviation raised for a category report by clicking on the “DEVIATION BY CATEGORY”button. User to select a category from the drop down list and click SUBMIT to generate the report.

User can generate a list of deviation raised for a facility/utility/equipment by clicking on the “DEVIATION BYFACILITY/UTILITY/EQUIPMENT” button. User to select an item from the drop down list and click SUBMIT togenerate the report.

(Click here to see a report for deviations by product/raw material)

(Click here to see a sample report for deviations by equipment)

http://gmpsop.homestead.com/accesss/samplereports/Deviation_by_category.pdf

http://gmpsop.homestead.com/accesss/samplereports/Deviation_by_equipment.pdf

http://gmpsop.homestead.com/accesss/samplereports/Deviation_by_Product.pdf


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End of manual

For more information please contact from our site www.gmpsop.com

User can generate a list of deviation raised for a product/raw material/component by clicking on the “DEVIATIONBY PRODUCT/RAW MATERIAL/COMPONENT” button. User to select a product from the drop down list andclick SUBMIT to generate the report.

lean-q database instruction manual - gmpsop · version: 1.0 2011 prepared by: lean-q ... existing...

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