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 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