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