The road from discovery of a new drug to its actual delivery to patients is long, bumpy, and expensive. On average, it takes approximately 15 years of research and development at a cost of more than $800 million for a new medicine to receive Food and Drug Administration (FDA) approval. It is estimated that only five of every 5,000 compounds in preclinical testing ever makes it to the human clinical trial stage. Of those five, only one is likely to be approved by the FDA. If a new drug is approved, the company producing the drug enters the next expensive phase: mass-production. Pharmaceutical companies lose an estimated $1 million in revenue for each day a new medicine is delayed from being delivered to market. To stay on top of these intense business and regulatory demands, companies of all sizes throughout the world are turning to MasterControl’s assortment of off-the-shelf, configurable software solutions to automate and innovate all GxP processes and enhance the full development lifecycle of their products, from concept to commercialization.
Pharmaceutical GxP Regulatory Requirements
According to a multitude of FDA regulations, including 21 CFR Parts 210 and 211 and current GxP guidelines, pharmaceutical companies are required to have specific controls for electronic systems in order to insure that data integrity is not compromised. Many pharmaceutical companies, especially those that market products outside of North America, must conform to management standards such as ISO 9000 as well. Public companies and those planning to go public are also subject to Sarbanes-Oxley Act (SOX) requirements. These regulations are in place to protect pharmaceutical companies and the consumers they serve.
A pharmaceutical company's ultimate goal is to produce a safe, reliable, and effective drug while maintaining compliance with GxP regulatory requirements. To achieve the goal of integrated and compliant GxP processes, a company must overcome many obstacles throughout the product development lifecycle, such as:
- Disconnected GxP Processes: GxP processes that are not connected to each other can cause delays and poor results. For example, a change control process that's not connected to customer complaint, CAPA, training, and other GxP processes is likely to cause delays in change implementation. A CAPA process that is not connected to the rest of the system may produce an unreliable root cause investigation due to a lack of adequate information.
- Inefficient GxP Systems: Pharmaceutical companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate GxP systems. Typically, to keep costs down, these systems are paper-based or hybrid paper/electronic in their early phases. In the long term, these inefficient systems will require employees to devote an overwhelming amount of time to tasks that could be streamlined by an automated system, such as: routing SOPs and other documentation; obtaining approval and signatures; face-to-face meetings to discuss changes; and manual search and retrieval of documents during FDA inspections.
- High Cost of Validation: 21 CFR Part 11 requires computer system validation as a way of ensuring the integrity of electronic records and signatures. Even if a pharmaceutical company successfully automates its manual record-keeping system, it still faces the daunting work and the high cost of validation. Labor-intensive validation tests conducted by internal staff and exorbitant consultant fees can easily double the cost of compliance.
MasterControl GxP Process Management Software Solutions
Because compliance is a perpetual state—not an event—MasterControl offers a suite of integrated GxP process management and document management solutions that are configurable and easy to use. MasterControl helps companies improve efficiency and sustain compliance by connecting different departments with each other and with pertinent data and processes, all within a secure and centralized Web-based system. This connectivity helps promotes departmental collaboration, quality, and compliance throughout the enterprise by allowing management to continuously monitor and proactively improve all GxP processes throughout the entire product development lifecycle. Processes include:
MasterControl makes it possible for pharmaceutical companies to meet key GxP requirements while also increasing efficiency and keeping compliance costs down. MasterControl helps companies to recognize GxP compliance as a part of the corporate culture by enabling compliance to be enforced across the enterprise in every department. By connecting company personnel with relevant data and processes, everyone is able to see “the big picture.” The result is an environment that fosters collaboration and allows managers to visualize and monitor all GxP processes as a unified system.
Validating a software solution and keeping it in a continuous state of validation is half the battle in maintaining compliance. MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and simplifying the validation of software upgrades, both of which are essential in reducing the overall validation cost.