Short Online video which will give you a feel for the challenges and how ProcedureCapture solves these.
Some of the isues that this raises are :
The current validation approach, which relies on manual systems is time consuming and inefficient as documents are needlessly recreated and tedious manual tasks are performed on a routine basis.
Need a Risk based Model to help concentrate on the areas which have most impact. Require flexibility to select different GAMP Risk Assessment models in terms of Risk Priority levels and Risk Detectability.
Manual traceability is difficult and error prone and there is a need for real time information on the links between Requirements, Tests and Defects while still having the visibility of the associated Risk priority right across this linkage.
Test results need to be recorded in such a way that an independent reviewer can compare the documented acceptance criteria against the Test evidence and determine whether the test met the relevant criteria.
ProcedureCapture covers Requirements, Risk, Testing, Traceability and Defects with no add ons.
All from one integrated, affordable and easy to use tool.