InstantGMP™ Release Notes for Version 3.010.001

InstantGMP™ Release notes for version 3.010.001 

New Functionalities

Quality Management System

  • Deviation Log
    • The Deviation Log documents and monitors deviations generated during batch production or entered ad-hoc and ties them to corrective and preventive actions (CAPAs) as part of the complete Quality Management System.
    • Effectively tracks and manages deviations
    • Record investigations and the root causes
    • Expedites investigations with the ability to create and assign multiple action items to users for executing and supporting the impact and risk assessment process with due dates, actions and email notifications
    • Assigns investigations to responsible users and monitors due dates
    • Integrates with Batch Production Records
    • Integrates with document management system
    • Enforces GMP compliant workflows and procedures
    • Automatically generates new CAPAs with a single click
    • Dispositions deviations and sends notifications for approval
  • Complaint Log
    • The Complaint log documents and monitors Customer Complaints and ties them to corrective and preventive actions (CAPAs) as part of the complete Quality Management System.
    • Effectively tracks and manages complaints
    • Record investigations and the root causes
    • Expedites investigations with the ability to create and assign multiple action items to users for executing and supporting the impact and risk assessment process with due dates, actions and email notifications
    • Assigns investigations to responsible users and monitors due dates
    • Integrates with document management system
    • Enforces GMP compliant workflows and procedures
    • Automatically generates new CAPAs with a single click
    • Dispositions complaints and sends notifications for approval
  • CAPA Log
    • The CAPA Log documents and monitors corrective actions and preventive actions (CAPAs) required as a result of audits, regulatory inspections, validation studies, product complaints and investigations, etc.
    • A CAPA form can be launched directly from a deviation or customer complaint
    • Links are maintained so users can review a completed process and see what triggered the CAPA
    • Tracks incidents and records the root cause of Corrective Action and Preventative Action requests
    • Creates and assigns multiple action items to users for executing and supporting the corrective action and preventative action processes with due dates, actions and email notifications
    • Creates and assigns multiple action items to users for verification processes with due dates, actions and email notifications
    • References affected SOPs and other documents with a direct connection to the document management system
    • Sends notifications for approvals
  • Change Control Log
    • The Change Control Log documents and monitors Change Controls as required as a result of audits, regulatory inspections, audits, product complaints, Corrective Actions / Preventative Actions and investigations, etc.  Controls changes to processes, artwork, blueprints, drawings, forms, contracts etc.
    • Manages all related tasks and actions involved in the change process – tracks and monitors implementation action items through completion
    • Pre-configured forms help automate the collection and tracking of data throughout the change control process, assisting in the classification and prioritization of requests.
    • Links change control records to other quality records, such as CAPA and documents
    • Creates and assigns multiple action items to users for executing and supporting the change control processes with due dates, actions and email notifications
    • Creates and assigns multiple action items to users for verification processes with due dates, actions and email notifications
    • Send notifications for approvals
  • Training Log
    • The Training Log documents and monitors employee training on documents and equipment, and records additional training as required as a result of policies, procedures, etc.  Training Groups provide an expedited way to create training curricula for each user role and department.
    • Records training requirements, activities and reviews
    • Integrated with equipment and document management functions
    • Allows users to capture full data of training and to view status of training
    • Documents from Document Management and attachments can be added to each Ad Hoc Training Record
    • Training assignments can be duplicated for another user
    • Provides a function to create Training Groups where curricula for specified roles / department can be defined
    • The curricula will allow the user to create a default list of documents and equipment that can be assigned to a role / department
    • Training records show Trainee’s and Supervisor’s signatures for each document read and understood by the Trainee
    • Training records show Trainee’s and Trainer’s signatures for each equipment assigned to the Trainee
    • Trainees can be automatically notified when document retraining is required
  • Create Labels from Dynamic Fields and Print from BPR
    • When Dynamic Fields are defined in an MPR, labels can be created using one or more of the dynamic fields.  Label header will contain the Batch #, Production # and Step # (BPR step where label is used).  A bar code for the batch # will appear at the bottom of the label.  These labels can be tested in the MPR and printed from the corresponding BPR.  The labels can be printed in portrait or landscape mode. 

Improvements

Fixes