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Regulatory Compliance

ProcedureCapture delivers faster, cheaper and better quality validation in FDA/EU regulated industries. 

ProcedureCapture® Overview

Short Online video which will give you a feel for the challenges and how ProcedureCapture solves these.

Validation should be part of any development and manufacturing practice. It is also requested by FDA regulations and guidelines through the overall requirement that "equipment must be suitable for it's intended use".



Some of the isues that this raises are :

TIME INTENSIVE PROCESS

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. 

RISK BASED

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.  

TRACEABILITY

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.

DOCUMENTED EVIDENCE

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.

Validation Lifecycle flow with ProcedureCapture.

Find out why Customers and Partners think so highly of ProcedureCapture®

ProcedureCapture covers Requirements, Risk, Testing, Traceability and Defects with no add ons.

All from one integrated, affordable and easy to use tool.

 

CONTACTS
Email: US@raltus.com
Email: Europe@raltus.com
Email: Ireland@raltus.com