A Complete EDMS Solution for Biotechnology Companies

The QUMAS Biotechnology Package is based on the flagship QUMAS DocCompliance™ electronic document management system. As an off-the-shelf regulatory content management system, DocCompliance ensures enterprise-wide consistency and compliance. The software enables organizations to create, manage and securely store all content, reports and records. Sophisticated built-in password policies protect against unauthorized access while the system supports the use of electronic signatures to document the completion of tasks.

Business Challenge

Biotechnology companies are faced with the challenge of meeting rigorous compliance and regulatory requirements while keeping technology and resource costs low. These highly regulated organizations must gather and manage large volumes of content from disparate functional groups. This information must then be organized to facilitate the exchange of information between the various internal and external stakeholders including regulatory agencies. The following challenges are also faced by several biotech organizations:

• Limited human resources with complex multifunctional roles
• Managing the lifecycle of documents by diverse authors, multiple reviews, collaboration with external and internal resources, and conflicting edits
• Proving a compliance system of record to regulators can be difficult
• Managing the workflow needed to promote and advance documentation is manually intensive, utilizing qualified staff for menial tasks
• Maintaining oversight of policies and procedures across the organization is next to impossible without an electronic system
• Unauthorized access can threaten intellectual property and create risks across the organization

Functionality

The QUMAS Biotechnology Package consists of the following main elements:

• Content Management
• Integrated Messaging
• Configurable Securities
• Version Control and Lifecycle Management
• Workflow and Electronic Signatures
• Advanced Search and Retrieval
• Built-in System Administration and Secure Audit Trail

The QUMAS Biotechnology Package can be used to manage a wide variety of content, including: Policies, Procedures, Standard Operating Procedures (SOPs), Work Instructions, Board Packs, Legal Documentation, Sales and Marketing Collateral, Regulatory Correspondence, R&D Documentation, Clinical and Nonclinical Data and Reports.

Solution Features

The QUMAS Biotechnology Package empowers biotech organizations with a cost effective, pre-configured solution enabling rapid deployment across the organization.

Average Implementation of 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 complete biotechnology solution

• Preconfigured document management (taxonomy, document types and workflow types) based on individual functional areas needs for groups such as Clinical, Nonclinical, Quality and Regulatory
• Module Structure Mapping based on CTD granularity and metadata requirements
• Generate Validation documentation automatically from your configuration
• Built in electronic signatures in accordance with 21 CFR Part 11
• Easy to use application for Bulk Importing of your existing electronic documents

Cost Effective

• Very Low upfront costs
• Ongoing costs lowest in class
• Leverage your investment immediately
• No additional costs for documentation, validation and training materials