Installation Validation

Our validation service allows you to plan and manage the assets of validating systems DATACHECK in a simple, effective and optimized.

Download the documentation of service..

 

To simplify the validation activities, increase efficiency, thus allowing the rapid introduction of our applications in the operating environments, DATACHECK is now able to support its customers in all activities of validation of their systems.

The experience of DATACHECK respect to the validation of computer systems created in the early 90's when you produce the first documentation to support validation. Since then, much experience has been accumulated and documentation of systems produced by DATACHECK has made ever more precise and more tailored to the needs of regulators. With the experience gained over the years and thanks to the skills, DATACHECK now offers this service to its customers to support all phases of validation.

The service is complementary  to the validation package, that can be provided with the product software

The proposal stems from the belief that high knowledge of the systems to be validated, tigheter with the experience gained in recent years, allowing to optimize the validation activities. In this way the times and start-up costs are reduced significantly.

The effect you get is quickly ascertained:

  • Significant reduction in time due to the perfect knowledge of the system
  • Significant cost saving throught reuse documents and activities common to most installations
  • use of a validation process is already known and proven

 

RISK MANAGEMENT

The validation process suggests that DATACHECK is strongly inspired by the information provided by GAMP and is strongly oriented to the assessment of risks (risk based). Using an approach based on monitoring and careful management can minimize the risks of activities to be performed, focusing on the aspects most criticized. It is therefore possible to reach easily and cost the objective of the compliance of systems with the existing regulatory framework

 

STRUCTURE DEDICATED

The validationd of the service offered by DATACHECK is done by a department dedicated to this activity, whose staff is separate and independet from those involved in the production systems. This organization provides resources to successfully combine a deep knowledge of systems and the status of independence from the development work on the systems themselves.

 

ORGANIZATION OF THE DEPARTMENT

The Service is characterized as an advice; in this way all the documentation remains the property of the Customer. Particular attention is paid to staff training on customer theoretical and practical aspects of Computer Systems Validation, ensuring the autonomous capacity to maintain over time the validation status of the system and providing an opportunity to re-use the experience to the validity of other systems.