Standards and Testing
We want to be clear and transparent with you so here’s some of the paperwork around testing, standards we comply with and how to undertake acceptance testing.
Spiral will perform some unit testing and integration testing to test the software does what you asked us to do. You will be responsible for additional unit testing, beta testing and user acceptance testing (UAT) to test the software does what you want it to do.
Spinnaker complies with The FDA Code of Federal Regulations Tittle 21, Part 11 (April 1 2014) on the relevant clauses relating to electronic signatures
Spiral is in the process of aligning with ISO27001
Spiral will use its best endeavours to avoid unavailability of the platform to your team or its permitted users due to server downtime attributable to malfunction, upgrades, preventable or remedial maintenance; except during agreed periods.
During the term of our agreement with you Spiral will provide hosting of your database and our software platform along with agreed backup and security services. This includes:
- physical infrastructure support services related to the database and platform
- fast, reliable and dependable access to the database via the Spinnaker or Discovery platforms
- personal support from the team at Spiral
All users will have continuous access to the software in accordance with agreed service levels.
You will have an opportunity to fully test the system before you launch it with your sites. All issues and bugs identified will be fixed at no extra cost.
While we test the project to make sure it works. You will need to undertake your own acceptance testing where you will test that what we have delivered is what you wanted.
The acceptance testing period may vary in duration depending on the number of issues or changes discovered and the time to resolve and re-test them.
There are likely to be multiple cycles of testing and resolution of issues before acceptance testing is complete.
Acceptance testing is your responsibility and your responsibilities include:
- planning for people, technical and data resources and making them available in a timely fashion
- author, review and sign off on UAT plans and scenarios
- define and focus on the high risk scenarios
- use the system in a real world scenario with real world data
- ensure end to end processes work as expected with Discovery
- people doing testing are trained/prepared, engaged and committed to the testing process
- work positively and collaboratively with Spiral to provide enough information to reproduce and ultimately resolve any issues found
- record issues in a clear and detailed manner, ideally with screen shots and/or video
- report on test progress to our project lead on a regular basis during acceptance testing
You will indicate when you have completed acceptance testing and the database is ready for enrolments. When you open your study for enrolments we will regard this as acceptance of the platform.
From that point your changes will be considered as support. Because we work using an agile methodology this makes little or no difference to the way we work together.
Spinnaker is used in over 46 hospitals across New Zealand & Australia and from Israel to Italy.
Read more on the Spinnaker website »
Discovery is a cloud hosted, software platform that supports medical researchers to assess eligibility and randomise patients participating in a clinical trial.
The platform is hosted on our dedicated cloud server in Sydney and accessed anywhere in the world through the internet and used via a browser. There is no software to install, it’s quickly setup by our team and its really easy for your dispersed team to use.
Discovery is used in New Zealand & Australian hospitals in a variety of novel and interesting ways. Talk to us to find out how Discovery might help with your pilot.