October 2, 2017

Software Modules

Administration/Setup Screen

The main menu choices have sub-menus to choose from in order to complete various activities. For example, Administration consists of sub-menus that open data tables. The Personnel table contains the names and contact information of personnel. The Vendor table contains the names and contact information of various material vendors. Under the sub-menu Material Data, there are two additional material sub-menus to take note of. Within the Administration/Setup screen, users can input information about:

  • Personnel (including generating a unique barcode badge for Part 11 digital signatures)
  • Vendors
  • Clients
  • Materials (including Material Types and Material Statuses)
  • Storage Conditions
  • Units
  • Bin Locations, Equipment, Facilities, and Rooms
  • Tests and Methods for Specifications

Audit Trail

With InstantGMP™, you can see a complete audit trail anytime, from anywhere.

Part 11 includes this requirement: “Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.”

The InstantGMP™ electronic batch record software maintains an online, real-time audit log to record when every screen is accessed, when any data is entered and the name of the person making the change to the system documentation. Maintaining this information is an essential element for complying with 21 CFR Part 11 for electronic documentation.

Material Control & Receiving

InstantGMP™ automatically adds part numbers and controls materials throughout the system. This manufacturing execution system automatically generates and tracks the numbers that are assigned in various stages of material control and manufacturing, and assures that your materials and batches are made in compliance with Good Manufacturing Practices (GMP). Allowing the system to generate the required numbers will let you manage all of the Master Production Records or Master Manufacturing Formulas with traceability to all of the raw materials and components used in the batch.

  • Manufacturing Execution System controls all materials’ attributes
  • Part numbers assigned automatically to each new material or component
  • Specifications have automatic version control
  • When a requisition to purchase a material is completed, a Requisition # is generated
  • When requisitioned material is received a Material Receipt # is assigned
  • Incoming materials in inventory can be tracked by Part #, Requisition # or Receipt #
  • When materials are used in Master & Batch records, tracking and tracing is easy

Projects

Projects are a precursor to creating Master Production Records within InstantGMP™:

  • Project names are fully customizable
  • Product names within the project can be generated
  • Personnel, Vendor, and Client will populate the Project once the information has been entered at the Administration Module
  • Each person can be assigned to a specific job function
  • A person may be assigned multiple roles per Project

Purchase Requisition Control

View and control your requisitions online, any time.

  • Only materials with approved specifications can be purchased
  • Specifications have to be established before materials can be approved
  • Only QA can change material status
  • Drop down lists ensure materials are only purchased from assigned vendors
  • Purchase history is always available
  • Amounts ordered for a material requisition can be converted to other units within the chosen measurement system
  • The system will assign a unique requisition number for each requisition created, and unique receipt numbers for each material ordered on a specific requisition order
  • Once a Requisition is signed and confirmed it cannot be edited.
  • The system will display a print icon yielding a PDF version of the requisition

InstantGMP™ offers SOPs for sale as sets or individually. SOPs that establish procedures for Purchasing include:

  • POL-0302 Vendor Selection and Qualification
  • POL-0307* Purchasing Requirements
  • SOP-100* Purchase Requisition
  • SOP-212* Program to Qualify Vendors

Room & Equipment Logs

InstantGMP™ has Room Logs and Equipment Logs that provides numerous benefits such as:

  • Provides a central location to document room names, equipment names and serial numbers
  • Allows entry of preventative maintenance dates and calibration due dates
  • Helps maintenance keep up with facility and equipment activities
  • Connects cleaning and maintenance activities with specific production batches
  • Reduces Quality Assurance review time because of access to real-time data
    keeps a history of every activity entered into the system

System Reports

InstantGMP™ comes with multiple reports: equipment PM/CAL dates, current inventory and inventory in Quarantine are direct reports which do not require any additional information to produce. Here are some examples of reports output by our software: