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MasterControl Inc.

FDA Compliance

Pharma’s Transition from Paper to Pixels

The FDA’s encouragement

Published: Tuesday, March 25, 2008 - 21:00

The advantages to pharmaceutical companies of using electronic solutions to modernize their paper-based or partially electronic processes are enormous. Automation speeds up and connects all interrelated processes (corrective and preventive actions, customer complaints, audits, deviation management, change control, training, purchasing, etc.). This eliminates errors due to human oversight and ensures Food and Drug Administration (FDA) compliance, which requires that strenuous controls be in place for ensuring the identity, strength, quality, and purity of drugs (21 CFR Section 211.100).

Automated solutions expedite communication with support-service companies, external partnerships, and vendors, and they reduce time in meetings with instant access to the most current data and information available. With a web-based system, current data and information can be accessed from any location in the world. Automated solutions also help keep executive management well informed by providing access to all company activities 24 hours a day. This enhances compliance and helps ensure smooth operations. With some systems, managers and other authorized users can even view critical-path workflows in real time to help avoid potential bottlenecks. Moreover, companies that automate their processes accelerate the development of new products and reduce the time-to-market for products currently under development.

The FDA’s campaign to encourage the change
The FDA’s campaign to encourage all pharmaceutical companies to modernize their paper-based (or partially electronic) processes is believed to be due to the slowdown in the availability of innovative medical products. According to one ongoing drug development study by Tufts Center, the cost and time of bringing a drug to market jumped from $231 million and 8 to 10 years in 1990, to $802 million and 10 to 12 years in 2001, to the current estimate of more than $1 billion and 12 to 14 years.1 The reason for this increase is thought to be the combined result of increased federal regulation and inefficiencies throughout the product development process.

In August, 2002, the FDA launched a two-year initiative, titled “Pharmaceutical GMPs for the 21st Century: A Risk-Based Approach,” also known as the Pharmaceutical cGMP initiative. Among the objectives put forward, the first was “to encourage the early adoption of new technological advances by the pharmaceutical industry.”2

Only five months later, in January, 2003, the FDA launched another similar initiative—this one directed at all life science companies. The express purpose of the Process Analytical Technologies, or PAT, initiative, was “To help make innovative medical technologies available sooner, and to reduce the costs of developing safe and effective medical products while maintaining the FDA’s traditional high standards of consumer protection.”3

In October, 2004, Lester M. Crawford, the acting commissioner of the FDA, in a speech he made before the R&D Leaders’ Forum, said:

“The GMP overhaul, which is catching up with almost 25 years worth of scientific and technological developments affecting drug manufacture, is now nearing completion. The measures we’ve adopted incorporate risk-based principles, science-based policies and standards, and integrated quality systems, and are meant to encourage drug firms to modernize their manufacturing processes. [emphasis added] We hope that these innovations will lower the production costs and increase the availability of more affordable medications, and thereby strengthen the public health.4

Managing the process of moving forward
Perhaps the main reason that some (particularly small to midsized) pharmaceutical companies may be reluctant to automate their processes is because, given the complexity of their operations, the idea of changing to an electronic system seems a bit overwhelming. The process of moving forward can be more easily managed if companies:

    • Develop a team of experts within the company from the areas most involved with regulatory documents—for example, product development, manufacturing, regulatory and quality—and create a short list of document control system “must haves.”
    • Bring an affordable, easy-to-learn, out-of-the-box document control system online early in the development process and start growing the company’s acumen as the product moves through the development phases. This helps build the submission.
    • For companies with products already being manufactured, start at either end and work toward the middle. Incorporate the document control system in manufacturing and distribution immediately, and use the system to track early stage products at the same time.

When companies feel more comfortable they can start using the system for training, to create e-mail alerts, and for regular, periodic internal audits. Once people get accustomed to using the system, they will grasp its power.

1 Tufts Center for the Study of Drug Development (ongoing study). Retrieved 
September 12, 2007, from csdd.tufts.edu/Research/Milestones.asp.
2 FDA Center for Drug Evaluation and Research. (February, 2003). Pharmaceutical cGMPS for the 21st Century—A Risk-Based Approach: Second Progress Report and Implementation Plan. Retrieved October 28, 2007, from www.fda.gov/cder/gmp/2ndProgressRept_Plan.htm.
3 FDA News Release, Department of Health and Human Services. (January, 2003). Retrieved December 31, 2007 from www.fda.gov/bbs/topics/NEWS/2003/NEW00867.html.
4 Crawford, L.M. (2004, October). Speech before R&D Leaders’ Forum. FDA U.S. Department of Health and Human Services. www.fda.gov/oc/speeches/2004/leaders1005.html.

This article was published originally in GxP Lifeline, the Master Control e-newsletter, and is based on The Pharmaceutical Industry’s Transition to Electronic Processes.


About The Author

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MasterControl Inc.

MasterControl software solutions incorporate 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 companywide. MasterControl solutions include quality management, document management, product life-cycle management, audit management, training management, document control, bill of materials, supplier management, submissions management, and more.