Validation of custom developed computerized systems
Aseguramiento del uso previsto del sistema.
The validation of computerized systems has the main objective of providing documentary evidence that ensures that the computerized system works according to its intended use previously determined and approved by the organization.
Risks of custom-developed computerized systems
The regulations tell us that the extent of the verifications applied during the validation project must be proportional to the risk that the computerized system brings to the process. The advantage of custom-developed systems is their adaptability to the company’s processes, but they add a very high risk to the process as they are specifically designed, tested, used and maintained only by the organization in question.
As it is not a market software, globally used and tested, it requires complete and detailed technical, functional and safety verification at the highest level.
Project plans and service agreements
They allow standardizing the development of the software by controlling its design, execution, and applying continuous monitoring.
They are applicable to technology service providers or internal departments of the company.
- The service agreed in a contract.
- Activities and persons responsible for each of the parties.
- Documentation required from the person responsible for executing the development
- Procedures to be followed by the person responsible for executing the development
- Traceability required between processes, risk assessment, verifications, deliverables, and control measures.
- Planning and monitoring of project milestones. Generating project quality reports.
- Available work environments.