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The path from discovery of a new drug to its actual delivery to patients is often long, bumpy, and costly. On average, it takes about 15 years of research and development at a cost of more than $800 million for a new medicine to obtain approval from the Food and Drug Administration (FDA). After approval, a company then begins to mass-produce its product, entering another expensive phase. It is estimated that it costs a pharmaceutical company $1 million in lost revenue for each day of delay in delivering a new medicine to market.

In order to stay on top of these intense business and regulatory demands, companies of all sizes are turning to the MasterControl family of off-the-shelf, configurable software products to automate and innovate document control and change management processes. In 1998, MasterControl Documents became the first document management software to enable pharmaceuticals and other FDA-regulated industries to meet FDA GxP requirements and comply with 21 CFR Part 11.

Regulatory Requirements

The FDA regulates the pharmaceutical industry according to a host of regulations, including the Current Good Manufacturing Practice (CGMP) outlined in 21 CFR Parts 210 and 211. Companies that maintain electronic record-keeping systems are covered by 21 CFR Part 11. Many pharmaceutical companies, especially those that market their products overseas, also conform to ISO 9000 quality management standards. Public companies and those planning to go public are covered by Sarbanes-Oxley Act (SOX) requirements.

Quality Challenges

A pharmaceutical company's ultimate goal is to produce a safe, reliable, and effective drug. To achieve the goal of high quality, the company faces many challenges in different fronts, including:



  • From research till the final phase of a New Drug Application, the pharmaceutical company must maintain rigorous documentation of quality management processes. Even after approval, the FDA may require ongoing studies. The challenge is to establish a secure, centralized, and efficient system for controlling documents-based processes and managing voluminous records generated by the R&D, clinical, manufacturing and technical services, quality, and regulatory departments.

  • Many companies risk getting a Form 483 because of an ineffective Corrective and Preventive Action (CAPA) process caused by unreliable data from disparate sources and inadequate investigation due to lack of information and oversight.

  • A change control process without the capability to notify affected parties (internal departments or external parties, such as CROs) in a timely manner, or the connectivity to invoke appropriate training upon approval of a change makes for a poor turnaround in change implementation.

  • Using an electronic record-keeping system that relies on validation by expensive consultants or requires labor-intensive validation tests by internal staff will jeopardize the company's efforts to comply with 21 CFR 11.

MasterControl Solution

The MasterControl™ integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance. MasterControl connects different departments with each other and with data and processes under a secure and centralized Web-based system. This connectivity helps promote quality throughout the enterprise by allowing management to continuously monitor and proactively improve the quality processes. MasterControl helps pharmaceutical companies meet key CGMP requirements and ISO quality standards, and at the same time increase efficiency and keep compliance costs down.

What Solutions Are You Looking For?

Roll over the list of solution categories below to view the related MasterControl product, then click to go to that solution's product page.



Document Control
Change Control
Corrective/Preventive Action
Training Control
Quality Audits
Electronic Submissions
Customer Complaints
Validation
Sarbanes-Oxley Act (SOX)

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