MasterControl Spark Document Management Software

Automate Your Preclinical and Clinical Document Management Processes with MasterControl Spark Document Management Software for Pharmaceutical and Biotech Companies

For many small pharmaceutical and biotech companies, GCP stands for "Great Complicated Paperwork" rather than "Good Clinical Practices." Keeping voluminous paperwork is an integral part of meeting the international, ethical, and scientific quality standards for designing, conducting, recording, and reporting trials that involve human subjects, but that doesn't make it any easier to handle. Small contract research organizations (CROs) also commonly feel overwhelmed by all the documentation required by the standard. MasterControl Spark™ document management software helps ease the burden of document management in this complicated environment.

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How Can Spark™ Document Management Software Help You?

MasterControl Spark™ document management software provides a solution for collecting, organizing, and reviewing all the documents required to meet the GCP requirements. It is specifically designed to help organize and control nonclinical, clinical, and regulatory documents for smaller pharmaceutical and biotechnology companies. It helps take the "complicated" out of the burdensome paperwork requirements.

Here's how MasterControl Spark document management system addresses some of the major challenges that small pharmaceutical and biotech companies face in meeting GCP requirements:

GCP Required Document Management Challenges

MasterControl Spark Document Management Software Solution

Disconnected Processes

Communication breakdown is likely to occur in a paper-based document control system that consists of manual, disconnected approval processes. Missing a step in the GCP process may cause critical delays in product development.

Connected Processes

MasterControl Spark document management software is an integrated solution that connects users, documents, and processes in a centralized system. This connectivity vastly improves communication and efficiency, ensuring that goals and objectives are met and completed in a timely fashion.

Poor Turnaround

For those with paper-based systems, paperwork often ends up in a pile on somebody's desk, creating a significant turnaround challenge in a sequential process.

Faster Turnaround

MasterControl Spark document management software automates data collection, routing, follow-up, and escalation of document review and approval processes.

Scarce IT Resource

In the smaller companies, IT resources for system implementation, training and validation are scarce. Many times this requires outsourcing to expensive consulting groups.

ASP Solution

MasterControl provides Spark document management software as an ASP offering to reduce IT resources requirements. Our experts provide rapid deployment, professional validation services and complete maintenance of your system.

Training Issues

Training system administrators is time consuming and costly. It also means you must designate an employee to specialize in this role or hire a new employee to assume the system administration function.

Minimal Training

System administrator training is unnecessary. MasterControl Spark document management system is ready out-of-the-box, requiring minimal user training. MasterControl's system administrators provide all the maintenance required to keep your system working smoothly.

Poor Tracking

It's time-consuming to physically track paperwork. A manual system makes it almost impossible to identify and avoid bottlenecks.

Automatic Tracking

The MasterControl Spark document management system tracks the document through the collaboration, review, and approval steps, allowing the document owner to efficiently move the document through these processes and complete their work quickly.

Summary of Features: MasterControl Spark document management system is an ideal solution for early stage pharmaceutical and biotechnology companies that need an out-of-the-box, preconfigured document control system based on best practices.

Below is a summary of its key features:

  • Best Practice Documents and Processes: The system provides a mechanism to use preconfigured document templates for participants to begin workflows, including templates for document types, collaboration, out-of-office, e-mail import, and other features.
  • ASP Model: MasterControl serves as the Application Service Provider (ASP) for Spark. The system is extremely easy to administer and can usually be installed in less than a week and often just in a matter of days.
  • Affordable. The total cost of ownership is minimal because no special equipment is required. The ASP model makes Spark document management system affordable for small companies who are not ready for a full-scale document control system.
  • Electronic Approval Signatures: The system allows documents to display for review, collaboration, and/or electronic approval, facilitating the approval process.
  • Turnkey Solution: MasterControl Spark is ready out-of-the-box, drastically reducing time required for implementation. There is no special hardware to buy or system to configure. Data backup, antivirus protection, and redundant hardware are all provided with minimal upfront costs.
  • Grows with Your Business: If required, MasterControl's Professional Services staff can make changes to the preconfigured software to meet new requirements as a company proceeds through its growth cycle. More importantly, as the company grows, you can move into a full MasterControl system that can include training, CAPA, process automation, etc. without losing the efficiency of the preconfigured system or changes that may have been incorporated along the way.
  • Compliant System: As with all software developed by MasterControl, the Spark document control solution is fully compliant with the software-related requirements of 21 CFR Part 11.
  • Continuous Validation: For FDA-regulated companies, MasterControl offers a "continuous validation" approach that dramatically cuts the time, pain, and cost involved in validation.

About MasterControl

MasterControl Inc. is a global provider of GxP process and document management software solutions for life science companies. The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit, or call 800-825-9117.