Regulatory Requirements for Clinical and Medical Laboratory Systems
Clinical labs must comply with the Clinical Laboratory Improvement Amendments (CLIA) to be certified to perform testing on human specimens. Labs involved in development of new tests and technologies and in clinical studies also must comply with FDA regulations. FDA-regulated labs maintaining electronic record-keeping systems must comply with 21 CFR Part 11. Public companies or those planning to go public or are acquired by public companies are covered by Sarbanes-Oxley Act (SOX) requirements.
Clinical and Medical Laboratory Software Quality Challenges
A laboratory's ultimate goal is to ensure the accuracy and quality of tests. To achieve this goal, the lab must address many challenges, including:
- Inefficient Quality System: Labs 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 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.
- High Cost of Validation: 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 lab 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.
MasterControl Integrated Quality Management Software Solution
Compliance is a state, not an event. A laboratory 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 making it easier to validate software upgrades, both of which are essential in lowering overall validation cost.
Contact Master Control for Clinical and Medical Laboratory Software Systems
To learn more about clinical and medical laboratory software systems, feel free to contact MasterControl representative today.