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.