Quality and Reliability
“For a medium sized CRO like us it is essential to avoid downtime during any system maintenance activity. Updating our current OC/TMS/RDC installation to the latest versions including the RDC HTML version was therefore a really challenging problem.
Using the rapidLIVE approach we managed to update our complete environment starting on a Friday afternoon and being live again on Monday, and this included the effort to exchange our complete hardware environment to meet our new corporate standards.
For our end users it meant almost zero downtime and a seamless transition, for our IT team a hugely reduced effort, for our QA team well tested validation documents and for our management team the availability of an additional RDC version for a very reasonable price.
“rapidLIVE update” provided exactly the solution we were looking for and which we could find nowhere else”
Peter Lipczak, Cyncron
Validation
Validation is a critical part of your successful OLS implementation and is often very time consuming. There can be a balance between meeting timelines and costs with the high standards required. This can result in compromises when creating the validation suite.
Using our highly tailored and integrated validation approach you can significantly reduce the validation overhead and ensure that you comply with your regulatory needs.
psiComply
psiComply is an integrated validation suite based on GAMP5 supporting upgrades and re-validations of Oracle Clinical, RDC, TMS, AERS, Argus and LSH. It consists of
+ Validation Master Plan
+ User Requirements Specification
+ Configuration Manual
+ User Manual
+ User Acceptance Test Scripts
+ Validation Report Template
+ Support during execution