Many life sciences companies find it advantageous to outsource some of their functions to contract manufacturers, testing laboratories, and research organizations (CxO). This may include the design of a protocol, selection or monitoring of clinical investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration (FDA). Outsourcing allows pharmaceutical and medical device companies to concentrate on their core competencies and at the same time reduce labor and overhead costs. In some cases, outsourcing provides access to expertise and facilities that don't exist in-house.
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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:
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.
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.