InstantGMP™ Release notes for version 3.011.001

InstantGMP™ Release notes for version 3.011.001                      04/08/2019

 

New Functionalities

  • Materials and Material’s Specifications can be deleted if they are not used on any Project or Requisition. When a Material is deleted, all the specifications associated with that Material will be deleted automatically.
  • A new column on Batch Production Record summary screen called “Review Started” has been added. This shows the date the Review process of the BPR started (first signature).
  • Customizable Inventory Labels: Each customer can design their own Inventory Labels. As part of this design they can choose which field they want to include on the label, the font size (small/medium/large) and the aspect ratio of the label (1×2, 2×3, 3×4, 2×1, 3×2 or 4×3). It can be previewed before the label design is approved.
  • Two new automated reports were created, the first report sends an e-mail with a list of material nearing expiry date and the second report send an e-mail with a list of materials nearing retest date. Both are sent on a weekly basis.
  • The min and max values in a Master Production Record will be scaled up/down when theoretical batch yield is scaled up/down. To create this new functionality 4 new fields were added to the BOM on the MPRs. These are “% Adjust”, “min”, “max” and “Scale” indicator. When you indicate that inventory will be used on a Manufacturing step in a scaled up/down MPR, the system will use the values defined in the BOM if the “Scale” indicator was selected. When the MPR is scaled those materials will be scaled appropriately (target, min and max).
  • For Manufacturing Instructions where target, min and max are not associated with an Inventory usage no scale calculation will be applied and they will remain the same after scaling up/down.
  • A new company specific field called Internal Lot # was created. This can be associated with each receipt of a material.
  • New functionalities were added to Requisitions:
    • For those customers using a separate procurement software, a new functionality allows materials to be received by importing them based on a spreadsheet template provided by InstantGMP.
    • A PO # can be assigned to each requisition.
    • An option is available to require an approval signature in addition to the current signature for each Requisition. Current customers will keep working with just one signature unless the request this option. If the option is selected, requisitions can be approved by e-mail. A new checkbox was created on the Personnel screen to select which users can be used as a “Remote Requisition Approver”
    • Requisitions will have 3 statuses if the two-signature option is selected (In-Progress, Ready to Approve, Approved).
    • When creating Requisitions, a new filter was added where users can filter by Vendors for materials associated with that vendor only.
    • Two new filters were added to the Requisition summary screen: a date range based on approval signatures and status of the requisitions.
  • New functionalities added to Specifications:
    • When copying or versioning up a specification, all the information from the original specification appears in the new specification.
    • A controlled document can be added to each specification version either as a document hosted on the InstantGMP Document Management system or as an URL from an external DMS.
    • Multiple Vendors can be associated with each Specification. Each vendor can have their individual “Alert Level Quantity”, “Reorder Level Quantity”, “Order Lead Time”, “Vendor Part #”, “Vendor Catalog #” and “Cost Per Unit”.
  • A pop-up link was added to the Material Receipt screen and to the Inventory History screen where each material’s specification can be viewed without leaving the screen.
  • Two new modules were added to our Quality System:
    • Audit Log – enable users to manage their internal and external audit processes including planning, scheduling, execution, response collecting, reporting, and closure.
    • Template storage – will help organize default templates used in the Quality System through a tagging process. Default templates are included in the system.
  • A new Picklist Module was added with the following functionalities:
    • Provides picklists for inventory management.
    • Indicates which receipts should be taken from inventory for a specific BPR or for a Pick Request.
    • Provides traceability between materials used in Picklists and Batch #s.
    • Provides Picklists that can be created and fulfilled for production or finished goods.
    • Shows if a quantity is within or outside the min/max range.
    • Allows Picklist materials to be returned to stock.
    • Maintains a history of Dates, Actions, Approvers and quantities of each dispensed material.
  • Audit Logs and Templates
    • Auditor Assignment: Each Audit Log record is assigned to an auditor.
    • Audit scheduling: Each Audit Log record is assigned a planned audit date. When an auditor is assigned to an Audit Log record, an email for that audit will automatically be sent to the auditor.
    • Filtering and Grouping: The Audit Log Records can be grouped or filtered for a date range to show Audit by status, auditor, audit type and planned audit date.
    • Audit workflows: The Audit Log record is used to provide a preordained workflow and to collect all the information related to the audit.
    • The documentation tab is used to track controlled documents from the DMS.
    • The Records tab is used to upload audit agendas, cover letters, NDAs and other relevant documents.
    • The Audit Report tab is used to collect responses and reviews from the audit team and relevant reviewers.
    • Link to CAPA System: CAPAs can be automatically generated from any audit log record.
    • Audit and Reports Templates: Templates are provided for Audit Planning, Vendor Qualification, Quality Surveys, Site Inspections and Audit Reports. Observations and additional forms can be uploaded and associated with each independent audit. Reports based on criteria such as risk assessment or user defined criterial are easily created from templates.

Improvements

  • “Vendor” was changed to “Preferred Vendor” on the Material Read-Only screen.
  • The default status for new equipment and new rooms is set to “In Service” as the default.
  • “Audit Log” under Audit in main menu was changed to “Audit Trail” to standardize naming conventions.
  • All the events associated with each Receipt # are shown ordered by Approve Date/Time in ascending order (last first) in the Inventory History screen.
  • When using Inventory on a BPR step, the Inventory Usage screen is sorted by Receipt # in Ascending order.
  • A column “Assigned To” was added to the Room Log summary screen.
  • A column “Assigned To” was added to the Equipment Log summary screen.
  • When a Material is received, the PO # will default to the PO # include on the Requisition.
  • A date/time of signatures was added to read-only screens of tabs where signatures are required once completed in the QMS module.
  • A “Print Button” was added to Inventory History screen to print Inventory Labels from that screen.
  • Theoretical batch yield and formulation ID can be changed until an MPR is approved.

 

Fixes

  • The system generated an error when trying to “split” an Inventory item coming from a batch. (FG/oWIP).
  • The Material Receipt screen was not showing the Preferred Vendor.
  • The Purchase Order PDF was showing the “Receipt Internal number” instead of the Receipt #.
  • PO was showing “Vendor Catalog #” whereas Requisition shown “Vendor Order #”.
  • “Send Reminder” and “Sign” buttons did not show on the Complaint Log or the Change Control Investigation Tab for the appropriate roles.
  • The Training Log did not show the last approved version of the Documents.
  • The Deviation Log Impact/Risk Assessment allowed user to edit while signed.
  • The BPR printout (PDF) show the “attached document info” twice.
  • “Update Attachments” screen was showing incorrect color scheme.
  • Automatic Report Notification was shown as failed even-though finish correctly.
  • Amt/Primary Container and # of Containers was not showing on MPR printout (PDF)
  • A Rejected Document in DMS that is versioned up did not supersede all previous approved versions.