As cyber threats increase in sophistication, Abbott Informatics founded the Medical Device Cybersecurity Program (MDCP) to lower cybersecurity risks related to their medical devices by increasing vigilance against developing threats and continually improving product security. MDCP was designed especially to augment the security of the STARLIMS Quality Manufacturing Solution.
The Medical Device Cybersecurity Program’s development and implementation was based on the best practices of the industry, regulatory guidance from the U.S. FDA (Food & Drug Administration), market guidance, customer procurement needs, and government agency requirements. In addition, MDCP is capable of integrating new standards and laws. Data protection is integral to STARLIMS products, and medical device security measures are built into their Quality Management System.
Medical Device Cybersecurity Program Features
External Communications – Maintaining relationships with stakeholders by sending communications regarding cyber threats, security, vulnerabilities, and software updates.
Program Monitoring – MDCP processes for monitoring and reporting ease decision making and improve accountability and performance. Performance-relevant data is gathered for analysis then compared to goals set for effectiveness, progress, and efficiency, allowing teams to make necessary corrective actions.
Security Education & Training – STARLIMS staff members are appropriately trained to carry out their respective roles for designing, producing, and supporting safe and secure products. They have also received training for meeting their MDCP responsibilities. Their training program includes secure development, organizational processes, product lifecycles, and cybersecurity awareness.
Security Event Handling & Incident Response – As cybersecurity is perpetually evolving, information regarding threats and vulnerabilities are gathered and evaluated consistently for countermeasures to remain compliant with laws and regulations.
Security Risk Management – Proactive cybersecurity risk management of products throughout their lifecycles, especially through security engineering.
Part 2 will discuss Risk Management Processes.
STARLIMS Integrated Solution
STARLIMS implements the latest advances of modern technology to provide a totally integrated solution that incorporates LIMS, Electronic Laboratory Notebook (ELN), Scientific Data Management System (SDMS), Advanced Analytics, and Mobile within a single application. This innovation makes the creation and maintenance of custom interfaces to third party tools unnecessary.
Alpha Engineering LIMS Implementation
Alpha Engineering Associates, Inc. has been involved with the implementation of over 50 LIMS systems ranging in size from small, “off-the-shelf” software systems to very large, highly customized, multi-functional systems, including STARLIMS, for both governmental agencies and private enterprises. For affordable client-focused network consulting services and solutions, please call Alpha Engineering Associates today at (410) 295-9500.