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Systems Validation

Home > Features > Systems Validation

Custom Text Messaging, Mobile Apps, Web and Digital Solutions: Data Collection | Compliance | Workflow

Enterprise Field Mobility, Salesforce Automation, mHealth Applications, Digital Journey Solutions

Systems Validation

Posted on November 15, 2017June 19, 2019 by William Eng
0

Mobile health apps, text messaging solutions and all forms of electronic systems are validated against the specifications set forth by regulatory 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.

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

Tags: HIPPA compliant texting, mobile health, mobile health apps, patient recruitment and retention software platform, text messaging

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