Software System Change Control and Validation – What you need to know

Anyone using a Computer Software system needs a reliable validation program (Computer Software Validation – CSV). We always need to know that the software is giving us the results we expect: It’s doing what we need it to do.If computer software is used in an organizational process or in a device itself, we must assess its impact and evaluate the risk. We can use ISO 14971  to do that evaluation (read more).

Fig 1. Orcanos ISO 14971 Risk Management System

Where existing data is impacted, we often must move (or migrate) data from one system to another. For example, we sometimes need to migrate Design Control documents created in Word, Excel, etc. into another electronic quality management system. We must be especially careful because the existing data may be being used by others. We also need to ensure that the source data integrity is maintained when we move it. And we have to always be thinking of the potential regulatory impact of moving data from one place to another. The impact of the migration on regulatory compliance is just as important as effectively controlling the change itself!

Fig 2. Orcanos built-in migration tools

Plan and Validate

Microsoft Office programs (like Word and Excel) are often not standardized. This means we have to effectively plan the migration of data and then validate it (with statistical observations) once it has been imported into the new system.  At Orcanos, we use a sandbox to create a replication of your production process. This allows you to test your migration process without losing downtime or having to implement any rollback procedures.

Fig 3. Orcanos Sandbox replication of production

The Full Lifecycle

The full Application Lifecycle Management (ALM) process must be followed when you make a change in any aspect of your system – whether hardware or software. All changes need to go through the verification and validation (V&V) process, adopted by the IEC 62304 (medical devices) and ASPICE (automotive). This process involves the following considerations: (read more)

  • Requirements
  • Design
  • Testing
  • Validation

Fig 4. Orcanos complete end-to-end ALM process according to IEC 62304

The Orcanos system allows you to isolate the sandbox test environment from the production process. The sandbox holds a complete copy of the production data. This approach ensures no interruption for your users while you are in the process of making, verifying, and validating your changes. 


Your validation plan must outline each step in the testing process: from the initial requirements and intended use of the product to the functional requirements of the software.

Fig 5. Orcanos testing management system

The Orcanos system ensures a seamless migration of data. We’ll help you validate your system and product software and meet all your regulatory requirements. And we’ll ensure no production downtime or interruptions for your users. 

We’d love to help. Contact our team and let us know what you need.

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