audit management system software

ComplianceQuest EDMS FastStart Program

industry best practices


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What is ComplianceQuest’s EDMS Faststart Program?

Are you an emerging growth company?Are you in the Life Sciences sector (Biotech, Cannabis, Medical Devices, Pharma)?Are you interested in getting an Enterprise Document Management system that is:

  • Fully compliant to 21 CFR Part 11
  • Validated
  • Ready to use in “Production” in as little of 5 days
  • Affordable

If you answered Yes to any of the above, the ComplianceQuest EDMS FastStart Program is the right solution for you! We believe the key to success for this segment is an efficient, robust EDMS system that is scalable, quick to implement and does not break the bank. Our seasoned solution architects and engineers have carefully crafted a solution that comes pre-configured to best fit your organization’s goals and objectives. We help you help you deploy gold-standard CQ-EDMS, based on industry best practices by reducing hundreds of manual procedures into just a few steps, so you can start using it immediately. From sign-up to go-live in less than 5 business days! We are not kidding.

  • Day 1: Sign-up and receive system access
  • Day 2: Watch Training Videos and Read the outlined Training Materials
  • Day3/4: Load company specific data per included on-boarding guide
  • Day 4: Review CQ supplied validation documents and sign-off
  • Day 5: Train your internal users and go-live
  • Day 6: Celebrate!!!

FEATURES

Document Management

ComplianceQuest’s Document Management Solutions Software is a comprehensive yet easy-to-use system designed to effectively manage all the documents you come across in your work flow while integrating with other quality processes critical to regulatory compliance. The CQ Document management solution’s step by step out of the box workflow is made of foundation blocks along with a built-in workflow indicator.

Training Management

Training employees in a timely fashion is a key part of quality and compliance management for any organization. Having a training management system that can help establish a stable, reliable and repeatable training management process is instrumental in realizing the vision of developing and maintaining the required skilled resources. Furthermore, industry and federal regulations such as ISO, FDA, OSHA, etc. also mandate the need for a training management framework.

 

CHANGE MANAGEMENT

Though companies strive for stability in their operations; changes in procedures, business processes, and product designs are vital for continuous improvement. Moreover, regulated and ISO certified companies are also expected to maintain detailed documentation on all changes that are made in a change management software. Since there are numerous change processes to manage, such as design specifications, SOPs, material changes, supplier changes, process changes, etc., companies need to have automation tools to deploy the change management in a consistent fashion. Not only can software for change management assure compliance, but it can also greatly enhance a company’s productivity.

FASTSTART

What do you get?

  • Pre-Configured based on best practices and out-of-the-box workflows.
  • Training and Self-Learning videos with training guides
  • On-borading Guide
  • Pre Validated
  • Software Environments
  • Software upgrades and updates
  • Platform and Application Administration
  • Technical Support-CQ EDMS
  • Upgrade to the full CQ EQMS suite at any time

Pre-Configured based on best practices and out-of-the-box workflows - ComplianceQuest’s proven EDMS-FastStart program configuration is based on decades of successful EDMS implementation expertise across a broad range of industries. FastStart provides for best practice guidance, based on our out-of-the-box workflows. We know how to implement world class EDMS workflows that optimize your processes and provide for an 1.opportunity to realize the productivity gains that best fit your organization’s goals and objectives.

Training and self-learning videos with training guides - ComplianceQuest provides a well-structured syllabus and training material to make implementation, data-transfer, testing and adoption of the EDMS-FastStart solution easy and effective.

On-Boarding Guide - ComplianceQuest provides detailed plans and checklists of tasks and activities from purchase to go-live to make CQ FastStart a successful implementation.

Pre-Validated, Including:
- Validation Certificate-Provided to certify that the specific CQ release has been OQ and PQ Validation tested.
- IQ or Installation Qualification-establishes documented evidence that a system is installed in the selected environments and ensures that the installation followed the correct steps. Competent technical resources perform and document the installation of the CQ solution based on an approved pre-established procedure. This document is referred to as Installation Qualification.
- OQ or Operational Qualification-verifies that the software will function according to its operational specifications. This define Inputs and the expected results in the Validation Protocol Functional Test Cases. Each of the CQ solutions has gone through exhaustive OQ Validation for each of the releases per our documented validation policy.
- PQ or Performance Qualification- is a collection of test cases used to verify that a system performs as expected under simulated real-world conditions.

Software Environments:
- Production Environment
- Sandbox Environment for you to play, test and validate

Software Upgrades & Updates - We are constantly improving our product offering based on customer feedback, market and industry trends and regulation changes. CQ releases updates approximately 3 times per year. These upgrades and updates are included and will be automatically applied into your Sandbox first and then into production.

Platform and Application Administration - CQ takes care of administration and maintenance of the platform and application, so you do not have to.

Technical Support-CQ EDMS - FastStart users will have access to technical support through E-Mail and our App Support portal.

Upgrade to the full CQ EQMS Suite at any time - 9.Whenever your company is ready for a full-featured, end-to-end quality management system, let us know, and we will work with you to upgrade you to the CQ EQMS suite.

How CQ validation works:

See an online demo of FastStart QMS today

Sign up for ComplianceQuest EDMS FastStart today: faststart@compliancequest.com

Related Blogs and Whitepapers

Audit Language Requirements
January 12, 2017
Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers
November 16, 2016
Regulatory Auditing Strategy
October 21, 2016
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