QMS Software (Q-Pulse)

Q-Pulse Overview
Quality Management & Safety Management Systems for organizations of all sizes.

 

FEATURES Q-PULSE BUSINESS EDITION Q-PULSE IMS UPGRADE Q-PULSE ENTERPRISE EDITION
# of Licenses Included with Purchase 1 Primary N/A 25 Primary, 250 Secondary
Max # of Licenses that can be Used with Edition Up to 25 Primary, 250 Secondary N/A Unlimited
# of Production Databases Included with Purchase 1* N/A 4*
Modules Included With Edition Q-PULSE BUSINESS EDITION Q-PULSE IMS UPGRADE Q-PULSE ENTERPRISE EDITION
LaunchPad 1 1 1
Corrective & Preventative Action (CA/PA) 1 1 1
Administration 1 1 1
Documents 1 1 1
Audits 1 1 1
Assets 1 1 1
People 1 1 1
Training 1 1 1
Customers 1 1 1
Suppliers 1 1 1
Workload 1 1 1
CA/PA Analysis 1 1 1
Incident Analysis 1 1
Occurrences (Forms) 1 1
Incidents 1 1
Additional Included Features Q-PULSE BUSINESS EDITION Q-PULSE IMS UPGRADE Q-PULSE ENTERPRISE EDITION
Document Retrieval Service (DRS) 1 1 1
Web Portal 1 1 1
Mobile Apps (iOS & Android Compatible) 1 1 1
Application Programming Interface (APIs) 1 1 1
Add-Ons that may be Purchased for Edition: Q-PULSE BUSINESS EDITION Q-PULSE IMS UPGRADE Q-PULSE ENTERPRISE EDITION
21 CFR Part 11 Functionality** May be Purchased May be Purchased Included
ECL2 Q-Pulse Validation Support Pack*** May be Purchased May be Purchased May be Purchased

 

*# of Production Database(s) & 1 Training Database included

** 21 CFR Part 11 Functionality includes: Audit Log Viewer (independent of application), Auto Log Off, Intruder Lock Out,Strong Passwords, Electronic Signatures (already included in all editions), Developer Support of Validation Document,Available and Executed Test Cases, Certificate of Conformity

*** ECL2 Q-Pulse Validation Support Pack includes: (CSVP) Computerized System Validation Plan, “Getting Started” document,SOP-Validation of Computerized Systems, SOP-Risk Assessment & Mitigation, (CRS) Configuration Specification, (IQ)Installation Qualification Protocol, (FRS) Functional Requirement Specification, (OQ) Operational Qualification Protocol,“Organizing the URS & PQ” document, (URS) User Requirements Specification Example, (PQ) Performance QualificationProtocol Example, Traceability Matrix, Final Report & Release Memo Template, Table of Contents, Appendix J-Audit Log

  • Modules
  • Technical
  • APIs
  • Related Services
  • Related Products

LaunchPad

  • Starting point for all Modules
  • Designed specifically to promote ownership and interaction in the QMS.
  • Provides a shortcut for each individual to personal and specific information about their compliance actions and activities.
  • Allows each individual to contribute to compliance improvement ideas across the organization, irrespective of their position or seniority.

CA/PA

  • Quickly and easily captures deviations, complaints, nonconformances, etc. from all aspects of the business.
  • Informs appropriate people of issues specific and relevant to them and consequently helps avoid repeat occurrences of mistakes.
  • Provides a mechanism to create workflows matching your needs and integrating with other modules in Q-Pulse.
  • Encourages a culture of learning and continual improvement and, in doing so, reduces organizational risk.

Documents

  • Allows for the efficient and effective management of document change from the initial request through revision of the document, approval, activation and distribution.
  • Radically reduces the time in implementing new procedures, by notifying approvers when it’s their turn to approve the document and reminding them if they forget to do so.
  • Holds everyone accountable with electronic signatures for approvals, acknowledgements and periodic reviews.
  • Extends your controlled documents beyond your organization’s walls via a secure web interface.

Assets

  • Sends email reminders before activities become due and sends out escalations when they are overdue based upon a frequency that you determine. Frequency may be based upon a fixed period or upon usage.
  • Checklists or procedures may be linked from the Documents Module ensuring you have the most up-to-date document linked to each activity to be performed. Records demonstrating the activity was performed may be attached (i.e. Calibration, Maintenance, etc.)

Suppliers

  • Maintains a register of current approved suppliers and a historical record of supplier’s performance.
  • Highlights suppliers deemed unsuitable based on previous performance.
  • Allows you to develop win/win situations and enhance customer satisfaction.

Customers

  • Maintains a register of complaints, compliments and correspondence.
  • Reports on customer complaint issues collectively or in isolation.
  • Allows organizations and customers to work together to develop win/win situations.
  • Contractual documents and/or records may all be attached to the Customer within this module.

People & Training

  • Provides a complete central register of all employees and their training and competency records.
  • Enables the planning and scheduling of future training events including automatic emailing to attendees.
  • Allows employee competency gaps to be identified and addressed in a systematic manner.
  • The People Module works closely with the Training Courses Module.  Job Roles, Competencies & Requirements may be linked together.  Applying a Job Role to a Person’s record automatically creates a Training Plan for that individual.

Audit

  • Manages the complete audit lifecycle from scheduling, planning and conducting, to reporting and following up actions through to conclusion.
  • Provides the capability of performing various types of audits including internal audits, supplier audits, record reviews, etc.
  • Allows organizations to load existing checklists, referencing standards and providing guidance to the auditor.
  • Provides a central repository for all audit information and allows organizations to demonstrate compliance on demand with minimal disruption.

CA/PA Analysis

  • Enables analysis of key CA/PA data and audit findings from every area of the business.
  • Contains graphical grouping and trend reports to help identify related issues and improvement opportunities, unlocking benefits for your organization.
  • Helps develop an ethos of continuous compliance improvement.

Workload

  • Offers a central source to manage and continually monitor QMS actions throughout the organization.
  • Enables reporting on completed, outstanding and overdue compliance actions across the system.
  • Only relevant information available to each individual to encourage engagement with, and contribution to, the overall success of the organization.

Occurrences (Forms)*

  • Provides a mechanism to create your own electronic forms with the ability to add confidential fields and set mandatory reporting timelines.
  • When using the corresponding mobile app, forms can be completed from anywhere, attaching and annotating pictures.
  • Forms with matching criteria set, will be automatically identified and can be worked together in one process flow. See the Incidents module for more information.
  • *Available with the IMS or Enterprise Edition of Q-Pulse

Incidents*

  • Provides a way to process a single report (completed form from the Occurrences Module) or multiple reports in a single workflow
  • Captures the data, from fields you’ve created, that are important to your organization for analysis and trending
  • Incorporates the ability to perform risk assessments throughout the process of addressing the issue
  • Allows multiple team members to stay informed and involved with stages of the workflow they are assigned to
  • Provides a direct link to the CA/PA Module, initiating or associating issues processed within that module
  • *Available with the IMS or Enterprise Edition of Q-Pulse

Incidents Analysis*

  • Going beyond CA/PA Analysis, allowing the analysis of fields you’ve created
  • Provides the additional benefit of incorporating Operational Data, comparing collected data against data sets such as number of cases, campaigns, jobs, etc within a specified period
  • Contains graphical grouping and trend reports to help identify related issues and improvement opportunities, unlocking benefits for your organization.
  • *Available with the IMS or Enterprise Edition of Q-Pulse

Technical

  • Q-Pulse is a Windows-based N-tier application that has been built on the Microsoft .NET Framework. This utilizes Microsoft SQL Server database technology and integrates with Microsoft Active Directory (AD).
  • Click-Once Deployment makes it easy to deploy with minimal end user interaction.
  • Q-Pulse may be placed on your server or you may chose to utilize our hosting services provided by Amazon.
  • Hosting Services

APIs

  • Allows your organization to connect other key systems used to Q-Pulse. No additional fees to subscribe to feeds, APIs included with purchase
  • APIs minimize the need for duplicate entry of data
  • Enables data capture at the point of use, reducing the risk of conflicting or outdated information
  • Web services APIs reduce manual interaction by automating how events are triggered in connected systems
  • Mobile Apps

Related Services

  • Systematic, organized process to teach and configure the QMS to exact client requirements
  • Experienced Quality Managers who know your processes, not only with Q-Pulse but incorporating the foundation of quality principles
  • Incorporating industry best practices with each client’s unique circumstances
  • Training Services
  • Configuration Services
  • Validation Services
  • Hosting Services

Related Products

  • Academy Product Page
  • ECL2 Quick-Create Add-On Product Page
  • Risk Product Page
  • Web Portal
    • Simple and easy access to the most important Q-Pulse Modules from any computer with an internet connection
    • Ability to create and manage CA/PA Workflows, perform Audits
    • Ability to view and acknowledge Active Documents as well as Approve Draft Revisions from anywhere, WITHOUT a VPN connection.
    • Reporting (Must be using the IMS or Enterprise Edition). Ability to complete electronic forms.