Documentum Software – Guideline for Operation

Standard Operating Procedure (SOP) and Guideline for Operation of Documentum software for issuance, approval, rejections, and retrieval of forms and formats.

Procedure for Operation of Documentum Software

1.0   Purpose:

    • To define the procedure for the operation of Documentum software.

2.0   Scope:

    • This guideline is applicable to Documentum software for issuance, approval, rejections, and retrieval of forms and formats.

3   Reference, and Attachments – Documentum Software:

    • Reference:

    • DMS User Manual
    • Management of user and master data in Documentum Software.
    • Attachments:

    • Documentum Access Authorization Form – Attachment – 1
    • Documentum Master Creation and Updation Form – Attachment – 2
    • Manual Form Issuance Record during System Breakdown – Attachment – 3
    • Template Retrieval Period Record – Attachment – 4
    • Reprint Request Form – Attachment – 5

4.0   Responsibility :

    • User (To access the Documentum system):

    • Ensure Windows login id is available to create a new account in the Documentum system.
    • Fill the “Documentum Access Authorization Form” for the creation of a new account and/ or allocation of rights or deactivation of the account in the Documentum system.
    • Get the “Documentum Access Authorization Form” checked by Department Head and approved by QA Head.
    • Coordinate with QA to fill the “Master Creation and Updation Form” for the creation or updation of the master list in the Documentum system.
    • QA Reviewer :

    • Ensure that, all the master data filled by the user in “Master Creation and Updation Form” as per the required format.
    • Import scanned documents (Forms / Formats) for issuance.
    • View uploaded approved documents.
    • Search the documents in Documentum software for need-based review (e.g. Approved / Rejected / Scanned documents in application).
    • Review the need-based audit trail.
    • Reprint the form on request.
    • Review the QMS forms received for review from users in the Documentum system.
    • Approve / Reject the task assigned by the user.
    • Department User :

    • Take the print and execute the intended template from the system.
    • Scan/ submit/upload the executed scanned form into the system.
    • Send the task to Department Head / Designee for review.
    • Perform correction in the original executed form if the form is rejected by Department Head during the review.
    • Re-upload the form to the system for review after correction.
    • Resend the task to Department Head / Designee for review.
    • Give a request for reprint, if required.
    • Department Head :

    • Check the “Documentum Access Authorization Form” for the adequacy of requests with respect to the job responsibility of the user.
    • Recommend the user for access through “Documentum Access Authorization Form” and for updation in “Master Creation and Updation Form”.
    • Ensure that, training imparted to the user for the new assigned rights.
    • Review the executed Forms received for review from the user.
    • Reject the task assigned by the user.
    • Approve the task assigned by the user.
    • Co-ordinate with the responsible users to complete the task upon receipt of mail intimation once the task gets overdue (from document validity).
    • QA Head :

    • Check the “Documentum Access Authorization Form” for the adequacy of requests with respect to the job responsibility of the user.
    • Authorize the “Documentum Access Authorization Form” and “Master Creation and Updation Form”.
    • Ensure that, training imparted to the user for the new assigned rights.
    • Review the executed forms received for review from the user. (QMS documents)
    • Reject the task assigned by the user. (QMS documents)
    • Approve the task assigned by the user. (QMS documents)
    • Coordinate with the responsible user to complete the task upon receipt of mail intimation once the task gets overdue (from document validity).
    • IT Department:

    • Check approved “Documentum Access Authorization Form” for New/Existing users.
    • Update the Active Directory as per respective SOP.
    • Send a scanned copy of the approved “Documentum Access Authorization Form” to Documentum Administrator for necessary updation in the Documentum system.
    • Maintain all the received approved “Documentum Access Authorization Form”.
    • Check approved “Master Creation and Updation Form”.
    • Send a scanned copy of the approved “Master Creation and Updation Form” to Documentum Administrator for necessary updation in the Documentum system master list.
    • Maintain all the received approved “Master Creation and Updation Form”.
    • Documentum Administrator:

    • Verify the received Approved form(s).
    • Make necessary updation in the Documentum system as per the “Documentum Access Authorization Form”.
    • Make necessary updation in the Documentum system as per the “Master Creation and Updation Form”.

5.0   Procedure for Operation of the Documentum system

    • Pre-requisite : 

    • Ensure that all necessary configuration/attributes/workflows are configured on the server by IT.
    • Windows login Id shall be available for users who are selected to access the Documentum system.
    • Assessment of infrastructure requirements like scanners, printers for handling various sizes of forms, papers, drawings, and barcode readers shall be done for effective use of the Documentum system.
    • Master data for Documentum system configuration by user site shall be submitted to the IT department as a soft copy (excel file) and approved hard copy.
    • Master data configuration verification shall be performed by the site users for correctness.
    • Define and establish the printer setting for the proper printing of the template through the “Documentum” system.
    • “Searchable pdf” option in the scanner setting make available for template scanning.
    • Checkout path and Temporary path shall be set from Settings options of the Documentum system.
    • User creation in the Documentum system:

    • QA person along with respective Department Head shall identify the Documentum users.
    • User in coordination with Department Head shall fill the “Documentum Access Authorisation Form” for the creation of an account and/ or allocation of rights and shall get checked from Department Head and approved from QA Head.
    • The user shall coordinate with QA User to fill the “Master Creation and Updation form” for creation or updation of the master list in the Documentum system.
    • These two approved forms shall be handover to location IT.
    • Location IT shall check approved “Documentum Access Authorization Form” and “Master Creation and Updation Form” for New/Existing users.
    • Location IT shall add New User as per respective SOP and forward the scan copy of approved “Documentum Access Authorization Form” to Documentum Administrator for necessary updation in the Documentum system as per the request.
    • For existing user location IT shall forward the scan copy of the approved “Documentum Access Authorization Form” to Documentum Administrator for necessary updation in the Documentum system as per the request.
    • IT shall send a scanned copy of “Master Creation and Updation form” to Documentum Administrator for necessary updation in the Documentum system master list.
    • Documentum Administrator shall do necessary updation in the Documentum system.
    • Authorized users shall access the Documentum system using windows login credentials.
    • Authorized users shall enter the correct Login ID and Password to login into the Documentum system.
    • Uploading of templates in local folders on personal computers:

    • All the templates required to be issued through the Documentum system must be part of the approved SOP.
    • The templates shall be reviewed by the QA reviewer for the correctness of details like title, form number, version number, etc.
    • The templates shall be scanned and saved at defined folders on the computer and shall be managed by SOP No., Form No, etc. for correct uploading of templates in the Documentum system.
    • Use appropriate nomenclature for saved templates for easy identification.
    • Import and allocation of scanned templates by QA Reviewer in the Documentum system:

    • The QA reviewer shall enter the correct Login ID and Password to login into the Documentum system.
    • Templates to be uploaded in the Documentum system, keep at a defined path.
    • Select appropriate document type for uploaded template i.e. QMS, SOP from the dropdown list.
    • Uploaded templates shall get arranged department wise under the Template folder as per the flow mentioned in User Manual.
    • The time period within which the executed templates required to be uploaded shall be defined in SOP based on the activity to be performed. Details shall be filled in attachment 4.
    • Enter the time period in the number of days field in the Documentum system.
    • Select the uploaded template status as Active.
    • Select the correct SOP number and SOP type for SOP templates.
    • The correct location shall be selected from the drop-down list. This location is the Users site/location name.
    • Store the templates in the template folder under the appropriate department folder path.
    • Additional relevant departments/groups can be selected to give read-only access to forms.
    • The printing process for uploaded templates:

    • The Department users shall enter the correct Login ID and Password to login to the system.
    • The user shall go to the appropriate location of the Template folder.
    • Display all uploaded templates lists under the Template folder.
    • The user shall verify the form for correctness before sending for the print process as per the procedure mentioned in the User Manual.
    • Take only one print of template per token number.
    • The user shall enter notification into the ‘Planning/Sending of workflow’ window.
    • This shall include the notification for all of the recipients.
    • Department Head and QA reviewer shall receive the notification through the mail of the print process.
    • After printing the template, the User shall Accept the task to remove the intended task from the task list as per the procedure mentioned in User Manual.
    • The printed template shall be checked for correctness before the execution of the activity.
    • The printed template shall have the details like User Name, Unique Token Number, and Barcode in the page header and page footer contains Request Date, Returning Date, and Unique Token Number for each print taken.
    • Watermark of “ORIGINAL COPY” shall be displayed along the border of the printed form.
    • If the above-printed details are not legible, the template shall be returned to QA, and a request for reprint shall be given.
    • Uploading process for executed scanned forms for review:

    • Authorized users shall enter the correct Login ID and Password to login into the system.
    • The executed form shall be uploaded in the Documentum system within the defined validity period.
    • The hardcopy of the original executed form shall be checked by Department User for the correctness of data filled in the form, the number of pages, the Unique Token Number, and the “ORIGINAL COPY” watermark to avoid the rejection of the form.
    • The scanned form to be uploaded in PDF format shall be stored on a defined path.
    • The path defined to upload the executed scanned form shall not have any other irrelevant files/documents to avoid the uploading of the wrong form.
    • After uploading the executed scanned form in the Documentum system, the form shall be deleted from the defined path.
    • The correct token number shall be kept for ready reference at the time of uploading the executed scanned form.
    • The token number which is printed on the form itself needs to be entered at the time of uploading the executed form.
    • The Incident shall be raised for the delay in submission of form for uploading in the Documentum system and this Incident number shall enter in Incident number field during uploading of executed form.
    • All entries shall be checked for correctness before sending the uploaded executed form for the approval process.
    • If the wrong token number is entered while uploading the executed form, follow the procedure mentioned in the user manual.
    • Review of executed scanned forms

    • Department Head / Designee shall review the forms for the correctness of all data filled and availability of all number of pages.
    • Department Head/Designee shall Approve or Reject respective forms to be reviewed. If Department Head Approves the executed form, the workflow of that SOP form shall get closed.
    • The approved form shall appear under the document list on the selection of the appropriate Department/Approved Folder path.
    • After the Accept Task process, the scanned document shall get removed from the Scanned Copy folder and moved to the Approved folder.
    • Display the rejected task in user login under tasks List in Bold text.
    • The rejected task shall check out from the system and the same file is get saved at the defined checkout path.
    • Note: Do not take the printout of the form saved at the checkout path.
    • Made corrections to the original issued and executed form (hard copy) of the rejected task.
    • Scan the corrected form to save at the checkout path with the same file name.
    • Delete the rejected file from the checkout path before uploading the corrected file.
    • After uploading the system, select the appropriate version number for the corrected uploaded file.
    • For QMS forms, after review by QA Reviewer documents moves to Department Head Task List for the review process.
    • After Department Head approval, QMS documents are finally approved by QA Head and the workflow of that document gets closed.
    • Archive the original issued and executed form hard copy with the respective department.
    • The QA reviewer shall make the reconciliation of received hard copies of forms against the token number generated for forms issued through the system.
    • Uploading of executed form after validity period:

    • Store the executed scanned form on the intended path.
    • At the time of uploading the scanned form, a valid token number shall be entered in the Token Number field.
    • Inter the incident number in the field provided.
    • This incident number shall be generated for the delay in uploading of executed scanned form.
    • Review of document status:

    • The status of documents shall be tracked by using the Advanced Search option.
    • The documents status as Approved, Scanned, and Copy, etc. shall be checked by using this function.
    • Handling of Reprint process of the template:

    • The incident shall be taken for the reprint of the template.
    • The Department user shall request to QA for the reprint of the template and submit the request as per Attachment – 5.
    • The QA user shall give the reprint of the template as per the procedure.
    • Identify the printed template by ‘REPRINT’ marking.
    • The defective printed template shall be destroyed by the QA person after reprinting of the appropriate template.
    • Issuance of scanned form when the system is under breakdown:

    • The printout of the active scanned form shall be taken by the QA reviewer and issued to the user department for execution.
    • Record the issuance in Attachment-3.
    • The department user after the execution of the activity shall submit the hard copy of the executed form to the Department Head within a defined validity period for review.
    • Log the receipt of the executed Form in Attachment- 3.
    • For QMS forms, the QA reviewer shall check the executed form for the correctness and approve or reject the same.
    • As soon as the Documentum system resumes the operation, print out of the form shall be taken by department user through the Documentum system for the form which is issued manually during system breakdown.
    • Enter the token number generated against the form number which is manually issued in Attachment-3.
    • Data from the manually issued executed Form shall be transcribed to the template which is issued through the system.
    • The remaining blank space on the manually issued form shall be canceled and reference of system issued Form Number and Token number shall be mentioned where the remaining data of activity to be recorded.
    • The manually issued form shall be kept along with the form issued through the system.
    • The process for uploading and review of the executed scanned form shall be followed.
    • The event for the breakdown of the system shall be raised.
    • Master Updation of Documentum system:

    • Any modification/deletion/addition of Area, Equipment, Instrument, SOP, and Department shall be evaluated for change in the configuration of the Documentum system.
    • The “Master Creation and Updation Form” shall be filled and marked for creation/updation/Deletion for SOP / Instrument List / Area List / Equipment List / Department.
    • Submit the approved “Master Creation and Updation Form” to IT.
    • IT shall check this form and send a scanned copy of the “Master Creation and Updation form” to Documentum Administrator for necessary updation in the Documentum system master list.
    • Documentum Administrator shall do necessary updation in the Documentum system.
  • Definition of Terms & Abbreviations :

    • Documents: Documents mean approved and scanned (in PDF) Forms and Formats which are to be uploaded into the Documentum system.
    • Template: A document or file having a preset format, used as a starting point for a particular application so that the format does not have to be recreated each time it is used.
    • Forms: A printed or typed document with blank spaces for insertion of details or information.
    • Formats: An arrangement or plan for something written, printed, or recorded.
    • Task: Task means a request or acquiring or printing or accepting or uploading the issued document.
    • Department User: All users of respective user departments (including QA) who are responsible to issue and execute documents using requisition, acquire, print, execute, scan, upload the executed documents.
    • Checkout path: The location path of the folder on the computer system where rejected task files can be saved through the checkout option in the Documentum system by the user.
    • Temporary path: The location path of the folder on the computer system where the files open in the Documentum system is saved temporarily.
    • BMR: Batch Manufacturing Record
    • BPR: Batch Packaging Record
    • IT: Information Technology
    • QMS: Quality Management System

Attachment – 1 – Documentum Access Authorization Form

Name of Employee:_____________________________________ Date:________________
Employee Code:__________________ Location:_____________
Department:_______________________Email_Id:_______________________
Login_id:_____________________________________ (same as windows login id)
User creation/updation : New / Existing
Existing Rights (Applicable for Existing user  only) :

(Mark on ()  Applicable rights)

Department User / Department Head /

QA User / QA Reviewer / QA Head

Training References no. and Date:_____________________
New Department (Applicable if change department) :______________________________
Documentum Privileges Requested:
  Sr. Group Name Yes / No  
1 Department User
2 Department Head/Designee
3 QA User
4 QA Head/Designee
5 QA Reviewer

Requested By:

Date:
Recommended By: Date:
Authorized By: Date:
Received By: Date:
Executed By: Date:
If the user left the company, fill in the following details, and Deactivate the user in Documentum System.
Date of Relieving:
Documentum user Deactivated on:
Documentum user Deactivated by:

Attachment – 2 – Documentum Master Creation and Updation Form

Name of Employee:________________________________ Date:______________
Employee Code:__________________ Location:________________
Department:_______________________
Email_Id:___________________________________________
Masters creation/updation/Deletion for :

(Mark on (Ö )  Applicable  action)

SOP / Instrument List / Area List / Equipment List / Department

(Mark on (Ö )  Applicable  Master and Add required details in Selected Master List Form)

Note: Fill the required form according to master

Form-01:  Area List

Form-02:  Equipment List

F-03:  Instrument List

Form-04:  SOP

Form-05:  Department

Requested By: Date :
Recommended By: Date :
Authorized By: Date :
Received By: Date :
 Executed By: Date :
  • Form – 01
Sr. No Location
Area Name
Room Name
Room Number
  • Form – 02
Sr No. Location
Equipment Location
Name
Equipment Number
  • Form – 03
Sr No. Location
 

 

Dept. wise Inst
Inst. Location Name
 Instrument Name
Instrument Number
  • Form – 04
Sr No. Location
 

 

SOP No
 Form/Format No
  • Form – 05
Sr No. Location
     Department

Attachment – 3 – Manual Form Issuance Record during System Breakdown

Sr. No.

Blank Form

Date

Time Form No. Issued By Issued To Department Validity Period

Event No.

 

Executed Form

Template issuance through the system

Received on

Received From Reviewed By Issued on Token No.

Uploaded in the system on

Attachment – 4 – Template Retrieval Period Record

Sr. No. Department SOP No. with version SOP Title Form No. with version Form Title Validity period in the number of days

Attachment – 5 – Reprint Request Form

Date Requested by Department Template Token Number Reason for reprint Event Number Reprint  Date Reprinted by

(QA Reviewer)

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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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