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EASILY IMPROVE ACCURANCE WITH

QUALITY MANAGEMENT SYSTEM SOFTWARE

The Quality Management System in InstantGMP™ provides a complete system for quality assurance and documentation for pharmaceutical, biotech, dietary supplement and CBD/hemp industries that make accuracy and compliance more efficient—all delivered in an easy to understand, structured format.

With a Quality Management System your operation will experience:

  • reduced human errors, scraps, and costly reworks
  • improved process controls
  • streamlined compliance with federal and state regulations
  • added quality assurance
  • increased customer satisfaction & trust

QUALITY ASSURANCE

IN A STAND-ALONE OR INTEGRATED SOLUTION

Designed by quality and regulatory experts, the Quality Management System is available as a stand-alone software called InstantQMS, or as a module that fully connects between the Electronic Batch Records, Inventory Management, and Document Management modules.

Various logs in the Quality Management System integrate to act as central hubs for quality assurance activities with the functions needed to standardize data collection for deviation tracking, root cause identification, and investigations.

Some of the features for the deviation log include streamlining management & tracking deviations to expedite investigations, root cause analysis, and reinforce cGMP procedures with the deviation log. Users can route deviation reviews, approvals, assign investigations to personnel, and monitor due dates from a centralized screen. With a single click, users can automatically generate new CAPAs for added efficiency.

The CAPA log is a centralized location designed for creating, recording, tracking & assigning CAPA-related actions. From the CAPA log, users can monitor incidents and root cause investigations. From another log, users can create a new CAPA entry. Together with the Document Management System, users can upload and reference related documents.

Companies can proactively handle the complaint process by using the built-in, standardized, controlled, complaint handling workflow. From the complaint log, users can capture important information and track complaints from start to end, and escalate as needed.

The change control log features pre-configured forms for collecting & tracking information throughout the change process, as well as monitoring enactment of action items. The log automatically assigns reviewers and approvers by applying pre-defined parameters and notifies relevant personnel of action steps via programmed system emails.

The Vendor Management feature provides a portal where virtual biotech companies can work directly with their vendors to edit and approve quality documents and contracts.

Room logs increase facility interconnectivity with room statuses, monitoring activities performed in rooms (such as batch production use), and automatically recording usage logs.

Features an equipment snapshot including a thorough history of all activities and usages, along with related batch production record numbers for enhanced traceability. The log automatically creates & records entries for completing activities (such as cleaning and calibrating) and using equipment in batches. Users can also add additional layers of control for equipment management while automating activities.

The Training Log acts as a mini-learning management platform where supervisors can store learning materials for personnel, track their progress and, with digital signatures, verify that each assignment was completed. Creating training groups (such as production line operators, for example) to improve organization is a breeze. If new materials are added or if retraining is necessary, automatic email alerts notify users. The Training Log can be fully integrated with an optional Learning Management System.

COMPLIANCE IS ASSURED WITH ADVANCED

SPECIFICATION CONTROL

Specifications for raw materials or finished goods are an essential component of Good Manufacturing Practices and are required for Biotech, Medical Devices, Dietary Supplements, E-Liquids and Pharmaceuticals Products.

InstantGMP helps manufacturers easily manage specifications for verifying the identity of incoming and outgoing materials:

  • A sequential version number is automatically assigned when a Specification is associated with each material part number
  • Each specification can identify tests, methods and acceptance limits as well as sampling plans to safety requirements
  • Different versions of a Material Specification may be used concurrently in different Master Production Records & Device Master Records
  • Retest Periods and Expiry Periods can be set for each version of a specification
  • Vendor information is tied to each version of Specifications for enhanced traceability

InstantGMP FEATURES

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