Software documentation

Yes. We can create or update software documentation for existing systems, even if they were developed by another vendor or your in-house team. We review the software and available materials, identify documentation gaps, and create documentation that reflects the current system. This can support ongoing maintenance, change control, software validation, knowledge transfer, or regulatory activities.

The required documentation depends on the software’s intended use and applicable regulatory framework. It may include user and software requirements, architecture and design specifications, risk-related documentation, verification and validation records, a requirements traceability matrix, user documentation, release records, and change control documentation.

For Software as a Medical Device (SaMD) or software that is part of a medical device, the documentation should also support applicable software lifecycle and regulatory requirements, such as IEC 62304 and the technical documentation needed for CE marking under MDR or IVDR, where applicable.

Yes. Many organizations have software that has evolved over time but lacks complete or up-to-date documentation. We can analyze the existing system and reconstruct requirements, architecture, and design documentation, traceability, test evidence, and change history based on the existing software and available materials.

This helps reduce technical debt and makes the software easier to understand, maintain, and validate.

Yes. We can assess whether your documentation is complete, consistent, traceable, and aligned with the actual software and its intended use.

Depending on your needs, we can review requirements, design documentation, risk-related documentation, test evidence, traceability, and change records and identify gaps that could affect maintenance, validation, audits, or regulatory submissions.

Documentation should evolve together with the software. A defined change control process helps ensure that each significant software change is assessed, documented, tested, and reflected in the relevant requirements, design, risk, and validation documentation.

For regulated software, this helps maintain traceability and provides a documented history of what changed, why it changed, how the impact was assessed, and what was tested before release.

Software as a Medical Device (SaMD) requires documentation that demonstrates what the software is intended to do, how it was designed and developed, how risks were addressed, and how its performance was verified and validated.

Depending on the market and product, this may include software requirements and architecture, risk management documentation, verification and validation evidence, traceability, cybersecurity documentation, usability engineering documentation, and lifecycle/change records. For the EU market, relevant software documentation forms part of the technical documentation supporting conformity assessment and CE marking under MDR or IVDR.