Mobile health apps, text messaging solutions and all forms of electronic systems have undergone a rigorous validation process to ensure its accuracy, reliability, and compliance with regulatory standards and/or functional requirements. Basic validation principles are based on the FDA’s 2011 Guidance for Industry Process Validation and is defined as follows:
The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Process validation involves a series of activities taking place over the life cycle of the product and process.1
The European Union’s Guide to Good Manufacturing Practice is similar. Manufacturers should be able to justify their standards, protocols, acceptance criteria procedures and records on the basis of their risk assessment. Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice applicable across industry sectors.
The systems validation process encompasses the full system development life cycle and includes the following critical elements: system requirements, system design, coding/customising/software development, testing by system provider, traceability, UAT, installation/configuration management and decommissioning plan.
Synegys has a systems development life cycle methodology addressing specific functional or regulatory requirements. This includes 21 CFR part 11, HIPAA, EU Directive 2002/58/EC, local text messaging regulations and local privacy laws. Synegys can provide a checklist of how our applications comply with major industry standards. Contact us for more information.
Validated System supporting Clinical Research Studies
Validated systems need to comply with security and privacy regulations and the study protocol. Here are some key features and requirements of our validated health solution to support clinical study research:
Electronic Data Capture (EDC): An EDC system enables the collection, management, and storage of clinical trial data electronically. Built-in are data validation checks and auditing capabilities to ensure data accuracy and consistency.
Compliance with Regulatory Standards: The system adheres to relevant regulatory standards, such as Good Clinical Practice (GCP) guidelines and the requirements of health authorities like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Audit Trail: Our validated system maintains a comprehensive audit trail that tracks all changes made to the data and user activities within the system. This ensures transparency and traceability for regulatory inspections.
Data Security: Robust security measures, including encryption, access controls, and user authentication, are in place to protect sensitive patient information and maintain data confidentiality.
Validation Documentation: The system’s validation process arethoroughly documented, including validation plans, protocols, test scripts, and validation reports, demonstrating that the system functions as intended.
User Training: Adequate training and education are provided to users to ensure they understand how to use the system properly and comply with relevant procedures and regulations.
System Maintenance and Support: Our validated system is regularly maintained and updated to address any issues or vulnerabilities promptly. Technical support is available 24/7 to address user queries and technical problems.
Risk Management: A risk management plan is in place to identify and mitigate potential risks associated with the technology, data, and processes.
Integration Capabilities: Our validated system allows seamless integration with other relevant systems and electronic health records (EHRs) to streamline data flow and enhance efficiency.
Data Backup and Recovery: Regular data backups and disaster recovery plans are in place to prevent data loss and ensure data integrity.
Developing a Custom Validated Solution
We can quickly deliver a validated custom health solution leveraging mComply, our AI-powered health technology platform. These solutions integrate text messaging technology, web-based applications, and mobile apps, providing an environment to support diverse study protocols.
1US Food and Drug Administration. Guidance for industry process validation: general principles and practices. 2011. Available from: https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf