When a company transfers a function to a contract organization, the CxO becomes subject to the same regulatory action as its client. Contract organizations share with their customers the burden of compliance.
Contract research organizations that help make medical devices are covered by the FDA's 21 CFR Part 820 and 21 CFR Part 11 (for those maintaining electronic record keeping systems). Organizations contracted by medical device companies with presence in the global market are also likely to conform to ISO 13485 (Medical Devices - Quality Management System - Requirements for Regulatory Purposes) and ISO 9000 quality standards.
CxOs contracted by pharmaceutical companies must comply with such regulations as 21 CFR Parts 210-211 and 21 CFR Part 11 if they maintain electronic-record keeping systems. Public companies or those planning to go public or are acquired by public companies are covered by Sarbanes-Oxley Act (SOX) requirements.
A contract organization shares the sponsoring company's ultimate goal, which is to manufacture a safe, reliable, and effective product. To achieve this goal, the CxO must address many challenges, including:
- Inefficient Quality System: Companies with multiple facilities and employees in different locations may find it cheaper initially to maintain separate quality systems, especially paper-based or hybrid systems. In the long term, however, these systems are inefficient, requiring tremendous man-hours in terms of 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.
- Disconnected Processes: Quality 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 quality processes is likely to cause delays in change implementation. A CAPA process that's not connected to the rest of the quality system may produce an unreliable root cause investigation due to inadequate information.
- 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 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 a company's compliance cost.
Compliance is a state, not an event. Contract organizations must not only attain compliance, but sustain it year after year. The MasterControl™ integrated quality management suite is a configurable, easy-to-use solution that helps companies attain and sustain compliance with FDA and other regulations by automating and managing quality processes in an efficient and cost-effective manner.
Recognizing that validating a software solution, and keeping it in a constant state of validation, is half the battle in sustaining compliance, MasterControl is actively developing new ways to reduce the time and effort involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
Contact MasterControl Today about Contract Organizations
Whether a company is looking to learn more about Contract Organizations or MasterControl's time-tested software compliance solutions, MasterControl's experienced team can help. Contact MasterControl online or call toll free at 1-800-825-9117.