GXP International (GXPI) has announced that its X-Docs Capa module has been selected by Renovo as a hosted system to manage vital documents for the company's drug-development process.
Renovo uses the GXPI Corrective Action and Preventive Action (Capa) module, which is part of the X-Docs portfolio, to electronically track and manage its corrective and preventative management programme.
Used in a hosted system environment, the Capa module minimises installation costs, reducing overall implementation and licensing costs of the product for the customer.
Renovo uses a predominantly paper-based documentation system where documents are circulated for approval and stored in a central repository.
Current regulations require that a robust Capa process is in place and that pharmaceutical organisations can demonstrate that a thorough assessment of corrective and preventative actions has been made within a given timeframe.
To achieve regulatory compliance, Renovo decided to integrate an electronic system with its existing processes, selecting the GXPI Capa module for use as a hosted system from the GXPI data centre due to its flexibility and ease-of-configuration.
Using the Capa module as a hosted system has removed the need for Renovo to carry out extensive installation qualification, leaving more time to focus on performance qualification testing of the system against pre-defined user requirements, as well as reducing implementation and maintenance costs.
The system also enables greater visibility of Capas across all departments without compromising the safety of data, as it is access remotely by authorised users via a secure internet connection to GXPI's validated servers.
X-Docs is a modular platform built on Microsoft Sharepoint and facilitates simple compliance with industry regulations.
The Capa module is based on the principle of continuous improvement, minimising delays to product and document release and sign-off by enabling the efficient handling of workflow issues.
As all information on any given Capa is contained within one document, information can be handled efficiently with minimal risk of error.
Being a validated electronic system, the Capa module also provides the assurance that approved Capas can not be altered once data are submitted.
Steve Lomax, vice-president - quality assurance at Renovo, said: 'We have been impressed with the way the Capa module has integrated with our existing processes.
'Within the system, we can manage, track and resolve quality issues effectively.
'This helps us to maintain regulatory compliance and also raises awareness across departments of their requirements to comply with regulatory standards of GMP and GCP activities in the clinical development of pharmaceutical products.'
