Overview

Biotech EDMS System: QUMAS Biotech Webinar

QUMAS Biotechnology Software Package Product Benefits

The QUMAS Biotechnology Package offers an industry-leading electronic document management system to small biotech companies at an affordable price.

The benefits include:

Validated go live within 30 days

This QUMAS Biotechnology Package is ready to use out of the box and can be implemented, validated, and trained for go live all within 30 days. All of the configurations, materials, wizards and documentation required are supplied with the system. The solution is compatible with all existing documents, document management workflows, and processes, and all existing content will be automatically loaded into the system and validated before go live.

Biotech industry practices pre-configured and ready to use

Gain access to the leading eDMS in use in over 250 facilities globally, with pre-configured practices for document control and regulatory compliance to guide you in the best practices being used across the industry. All of the QUMAS DocCompliance functionality is available in this packaged offering, in a manner that ensures ease of adoption with fast track training. Leverage the QUMAS compliance expertise, as configured in the system, to ensure a compliant organization from the outset, making the company more viable in a regulatory context and more attractive to investors and partners.

Scalable solution that grows as the company grows

Implement for 10 users, and grow to 100s – the Biotechnology package can be added to as the company grows, ensuring successful on-boarding while maintaining document control and regulatory compliance.

Extend and integrate with other systems as requirements expand

As the company progresses and requirements expand beyond document control to submissions, integrate automatically with leading publishing solutions. These integrations are simple plug and play, not requiring expensive consulting days to move forward when you are ready for submission.

A cost effective world class solution at an industry leading cost

Smaller companies who can now leverage the same electronic document management software as the leaders in their space in a cost effective and highly efficient package. With a minimal upfront cost, and a cost per user of $1 a day, every organization, no matter how small, can have access to world class solutions. By offering a hosted system, QUMAS reduces costs since a hardware investment is not required, enabling clients to have all the benefits of an electronic system with low overhead cost.

High security, availability and reliability

The QUMAS hosted solutions are available through an enterprise-class data center designed to support and protect mission-critical IT operations as well as offer high security, availability and reliability to all users of the system. A hosted solution provides flexibility to meet the dynamic needs of life sciences companies without the worries of adding resources, infrastructure and capacity. Full service, 24/7 product support is offered to ensure the management of software deployment lifecycle from initialization through production to any upgrade services. In this way, you eliminate the need for dedicated IT resources and redeploy IT on more strategic projects. The QUMAS hosted solution provides a high level of stability and reliability for today's users and is scalable to accommodate future expansion and growth.

For further details see the table below.


Keypoint	Benefit	Details
Fast	Go live in 30 days	You will be up and running with a fully configured and validated system within 30 working days: 1 week - contractual paperwork 2 weeks - install, load and configure 2 weeks - validate and train your team All wizards, materials and documentation are supplied with or generated by the system
Pre-Configured	Pre-configured complete biotechnology solution	Preconfigured document management (document types and workflow types) and Module Structure Mapping to eCTD Easy Plug & Play with Publishing Tools for Regulatory Submissions Built in best practices plus highly configurable mapping to your own terminology and structures Start with our ideas and best practices, and build in your own Generate Validation documentation automatically from your configuration Built in electronic signatures and meaning of signatures in accordance with 21 CFR Part 11 Bulk Import your existing electronic documents with an easy to use application
Best of Breed	Best of breed, world class enterprise solution	In use in over 250 global installations Same software application as implemented in global tier one pharmaceutical companies (your competitive differentiator in the establishment of engagements with Pharmaceutical companies) Scalable from 10 to 120,000 users Successful in over 15 years of FDA auditing – best practices learned from engagements with tier 1, 2, and 3 life sciences companies, and built into the solution Proven path to submission approval across global regulatoryagencies See QUMAS DocCompliance brochure for a full list of the document management features Wide reference base available, along with case studies
Extendable	Extendable to a complete suite of life science solutions	Each of the following modules are available for integration: Preconfigured manufacturing and quality management module Including Venatron, CAPA and Change Control Management Additional configurations, document types and workflows can be added by your administrators (no expensive consultants required once administrator is trained - easy to use wizard interface drives new configurations) Plug in Dashboarding of key metrics and user designed graphs Integration to line of business applications via the QUMAS Software Development Kit Solution scales from a cost effective 10 user system to any scale you reach Server based automated document comparison module Scanning module to automate paper ‘take on’ for clinical trial documentation Templates matching all standard eCTD document types
Easy	Easy to use	Web Portal based interface No client footprint required (installation servers required) Easy to use interface that maps to your organizational structure Simple configuration before and after implementation – no expensive consulting required to add to or change your configuration CBT and Fast Track training
Compatible	Compatible with all your documents and processes	Compatible with all R&D document types and all R&D file formats Automated conversion to PDF for compatible reviewing on any workstation Compatible with your existing in house IT systems
Cost Effective	World class solution out of the box at an industry leading cost	Very Low upfront costs Ongoing costs lowest in class Leverage your investment immediately No additional costs for documentation, validation and training materials
Externally Hosted	Reduce hardware costs	Fast track the deployment of compliance solutions Avail of off-site backup and disaster recovery Evaluate new environments Focus on core competencies within the organization rather than on IT

Learn More about the QUMAS DocCompliance Solution