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Quality Management System

for Virtual Biotech Companies

Now, more than ever, quality management is a high priority for companies in regulated industries. There is a constant need to implement Continuous Process Improvement principles as a way to ensure product safety and efficacy, keep costs down, and of course provide quality, consistency, and traceability. Our drug development experts designed an FDA compliant quality management and vendor management system specifically for virtual biotech companies. We understand your needs: let us help you succeed.”

InstantQMS

Is a complete, simple, and affordable Quality Management System software designed by quality and regulatory experts for virtual biotech companies.  It can also apply to small-to-midsize manufacturers in a variety of industries including:
  • Biopharmaceuticals
  • Biotech
  • Cannabis
  • CBD
  • Cell Therapeutics
  • Dietary Supplements
  • E-liquids
  • Hemp
  • Herbal Products
  • Kratom
  • Medical Devices
  • Medical Marijuana

MANAGE PROCESSES & COMPLIANCE

FROM ONE CENTRALIZED HUB

InstantQMS™ is a complete Quality Management System that is fully integrated with a complete set of Standard Operating Procedures that work together with processes and logs for incidents, customer complaints, CAPAs, change control, vendor management and document management. Companies in the preclinical through early clinical development stages will achieve the fastest start to managing quality through this system in combination with an optional Learning Management System, guided workflows and autonomous operations.

Effectively track & manage deviations

  • Record root cause investigations
  • Expedite investigations
  • Support root cause analysis processes
  • Assign investigations to users while monitoring due dates
  • Reinforce cGMP procedures & workflows
  • Automatically generate new CAPAs with a single click

A proactive complaint-handling process

  • Standardize complaint handling
  • Track complaints from beginning to completion
  • Capture critical information with escalation capabilities
  • Control record-keeping documents, investigations, and follow-ups

A secure & centralized repository for all CAPA-related activities & documents

  • Track incidents, as well as root causes
  • Create, assign, and track multiple action items
  • Launch a CAPA form directly from another log
  • Reference documents with integrated document management

Automated, pre-configured forms for collecting & tracking of data throughout the change control process

  • Track & monitor implementation of action items
  • Automatic assigning of necessary reviewers & approvers by predefined parameters
  • Notifications of action steps via email

Easily and securely ensure control processes are followed:

  • Captures complete records of audits performed
  • Ensures against documents being altered
  • Expedites investigations

Links materials to vendors from end to end

• Controls receiving by automatically attaching vendor record to material lots
• Ensures lot numbers follow materials throughout the production process

Capture training data such as training materials and required signatures

  • Track personnel training statuses
  • Record training activities
  • Easily duplicate training assignments for training groups & other users
  • Automatically notify trainees of retraining when necessary

The software comes with a full set of Standard Operating Procedures. The templates and forms that are identified in the SOPs are also in the Template Storage for easy access.

Each of the templates from the SOPs included in the software have been converted into forms that can be used in the on-line collaboration feature of the Vendor Management Module.

This module is used to file non-controlled documents and files that do not need the rigorous control provided by the Document Management System.

Jeremy Hall

BIOTECH & PHARMA

Contact Jeremy Hall at (919) 657-0953.

instantgmp-robert-pochadt

HEMP/CBD & DIETARY SUPPLEMENTS

Contact Robert Pochadt at (215) 968-5414.

Have Questions?

You can request a demo by completing the form below or by giving Jeremy or Robert a call.

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