October 11, 2018

Quality Management

All-in-One Manufacturing and Quality Software - Quality Managment Module

Our Quality Management System (QMS) is a module that fully connects between the Electronic Batch Records of InstantGMP™, Inventory, and Document Management modules. The Quality Management System Software module was designed by quality and regulatory experts, and provides additional layers of quality control and documentation for workflows in an easy to understand, structured format that benefits companies by:

  • Increasing customer satisfaction & trust
  • Complying with federal and state regulations
  • Reducing human errors, scraps, and costly reworks
  • Improving process controls
  • Added quality control through automated log updates with Equipment Integration
  • A set of Quality Management SOPs is included in the software

Joining with the Equipment Log and Room Log, we created additional, quality management-geared logs within our software to help companies take their products to a new level, including the CAPA Log, Change Control Log, Compliant Log, Deviation Management, and Training Log. All the logs act as a central hub for quality activities with the functions needed to standardize data collection for incident tracking, root cause identification, and investigations.

CAPA Log: 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

Change Control Log: 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

Complaint Log: 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

Deviation Management: 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 efficiency 

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

Room Log: Room logs increase facility inter-connectivity with room statuses, monitoring activities performed in rooms (such as batch production use), and automatically recording usage logs

Training Log: 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

Vendor Management: This feature provides a portal where companies can work directly with their vendors to edit and approve quality documents and contracts. This is fully integrated with a full set of preloaded forms that make it easy to manage your contractors and suppliers. Guided workflows and autonomous operations coupled with off-line signatures make this the fastest way to get started in managing quality in a regulated industry