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InstantGMP™ Release Notes for Version 3.018.001

System Release Compliance Report for v3.018.001

New Functionalities

  • Equipment Scheduler:
    • Tasks for Equipment can be scheduled on a repeating cycle, e.g. daily, weekly, monthly and annually.
    • User has ability to schedule tasks such as equipment calibration, cleaning, preventative maintenance or other activities.
    • System will send notifications to multiple users. Notifications can be sent on a preset number of days before the task is scheduled.
    • An ad hoc document or file can be uploaded into each activity in a log.
    • A Deviation or an Incident can be created automatically if the task goes past its due date.
    • An Equipment Task report contains all non-completed scheduled and work order activities for all equipment.
  • Personnel Tab and Activity Tab added to Master Production Records (MPR) and Batch Production Records (BPR).
    • Users including External Users can be selected on a Personnel tab on a Master Production Record or a Batch Production Record.
    • Any user including an External User on the Personnel tab can be designated an MPR Approver or a BPR Reviewer.
    • If a user is designated as an MPR Approver or a BPR Reviewer on the Personnel, this designation will be copied in the Personnel tab of the corresponding Project(s).
    • If a user designated as an MPR Approver or a BPR Reviewer on a Project, the user will appear on the Personnel tab of the MPR or BPR with the Approver or Reviewer designation.
    • Activities and notification can be assigned to any of the users on the Personnel tab.
    • A “User” selection will be part of the Search panel so selecting a user will show the BPRs where that user is listed on the BPR Personnel tab.
    • If a user is disabled, they will be automatically removed from the Personnel tab.
  • New Document Management System features added:
    • The Document Management System now allows documents to be created and edited on-line with complete tracking of changes made by each reviewer.
    • Documents can be downloaded in bulk.
    • Attachments can be managed in addition to forms in the Vendor Management module.
    • Images can now be imported and added to on-line documents in the DMS and to forms in the Vendor Management System.
    • A new Filter called “Reviewers” was added above “Approvers” to provide a way to search for Reviewers in the Document Management System.
  • A new DBADM dashboard toggle will allow specification versions to be locked to documents versions in the Document Management System.
  • New Electronic Batch Record features added:
    • A unit family of Hours/Minutes/Seconds was added.
    • A Dynamic Field for Elapsed Time was added.
    • The min and max of a timer can be checked in a BPR manufacturing step.
  • An option was added to force new users to change their password the first time they log on.
  • The process for the Inventory on a Date report was changed to make it run faster.
  • Users can now requisition and receive materials by the vendor’s pack size or conversion unit, rather than the IGMP material unit.
  • Users can set up a conversion factor equation for calculations between families of units which the system will use to calculate the conversion in the requisitions and material receipt screens.
  • New function allows materials to show on a BOM, but not be used on a manufacturing step.

 

Improvements

  • Updates to the QMS include:
    • The documents in the Documents Tab of all QMS remain as the version attached when the log is closed out.
    • Date, Time, and Time Zone were added to the signature panel on the Change Control Action Plan screen.
    • Require at least one approver on the General tab. Warn user that approver(s) has not been added to the log.
    • The Audit Report tab does not lock until signed.
    • The “Actions Taken” comments are now viewable on the General tab of the Deviation, Incident, and Complaint Logs.
    • QMS Logs – date filters were added in search panels to allow users to search for any type of date on the summary screen.
    • When a document is automatically created in the DMS from the Vendor Management system, a History entry on that document is created explaining the origin.
    • Documents can be uploaded in bulk into the Vault.
  • “+” was added to forbidden characters in file names.
  • Controlled Document from DMS in a Specification now includes version #.
  • External Users and Inventory Operator have a new function to change their password.
  • An Export to Excel button was added to MPR summary screen.
  • When a Reviewer or Author is disabled, they can be removed from the Reviewer or Author list in the DMS.
  • Bin Location and Container _ of _ are now optional on the Inventory Label.
  • A “Status” column was added to Automated Reports.
  • The Guest Role Permission was added to the INV Product.
  • The “User Name” is mandatory on the Training Log.
  • The “Watermark” option is not shown for non-pdf documents in the DMS.
  • Column headings that were not needed are hidden on the Batch Production Record summary screen.
  • Dispense and Get Weight function updated.
  • Spaces will not be allowed in the beginning of a Formulation ID on the MPR cover page.

Fixes

  • User Filter in CAPA Logs Search Panel doesn’t filter.
  • Need error checking for PDF approval in Vendor Management.
  • BPR Reviewers Signatures do not appear in PDF printout after batch is closed.
  • “Filter by Material Type” on Inventory Management Screen does not return results.
  • BOM Export to Excel for BPR & MTO Unit Column shows code not name.
  • Copied documents start at Version 1 instead of 0 when Dashboard Setting is selected.

 

 

 

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