Qualified Environment for Life Sciences

Life Sciences manufacturers manage multiple responsibilities in the development, manufacturing and distribution of their life saving products. One of the most important aspects of running a successful operation is ensuring the manufacturing process is fully tested, verified and validated and results in delivering the highest possible quality and lowest risk to patients.

Global standards, like the ISPE GAMP© and regulators such as the FDA, issue guidelines and best practices to help companies achieve these goals and execute a more risk-based approach to validate their production processes. In the early days of FDA Part 11 system compliance, companies documented, tested and validated every part of the process to ensure all aspects of electronic documentation, and electronic signatures were fully validated. However, now with the broad acceptance, reliance and stability of cloud-hosted applications, regulators are encouraging greater adoption of these environments – and requesting manufacturers rely more upon the software providers to provide the tests and documentation - and keep manufacturers focused on quality and advancing innovation.

One of the most important issues for a cloud provider is ensuring that their life sciences customers are able to deploy and maintain the software that is used to manage GMP regulated processes in a validated state. The GAMP (Good Automated Manufacturing Practices) ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) emphasizes the importance of maintaining IT infrastructure in a controlled and compliant state to ensure the integrity and compliance of GxP computerized systems. The guide further highlights the necessity of a risk-based approach to ensure that computerized systems are effective, of high quality and fit for their intended use, which inherently involves maintaining the underlying IT infrastructure in a state of control and in compliance with regulatory requirements.

In order to achieve this state of control and compliance, QAD Adaptive ERP for Life Sciences provides life sciences clients with a qualified environment as a key building block to help them ensure that they have a solid foundation upon which to base their software validation requirements.

A qualified environment establishes confidence that computer systems, with their associated hardware, operating software and networks, used to operate QAD Adaptive ERP and QAD EQMS in the cloud, are compliant with the appropriate standards and approved design intentions and are capable of consistently operating within established limits and tolerances.

Computer System Assurance. Software application validation requires a qualified cloud environment as its foundation. As a primary value, QAD Adaptive ERP for Life Sciences’ Qualified Environment, when operated in compliance with regulatory requirements, provides assurance to clients that it is operating in a demonstrable state of control and compliance. This environment covers both QAD EQMS and QAD Adaptive ERP.

Reduces Operating Costs. Developing and maintaining the hardware and software as well as the processes, tests, documentation and personnel that support a qualified infrastructure, involves additional costs and risks.

Reduces Risk. QAD Cloud for Life Sciences lessens the risk that a company faces by providing both the qualified environment as well as support for ensuring compliance with the current rules, regulations and quality standards of the FDA and other global regulatory and quality organizations.

Single Tenant Environment. A dedicated single instance of QAD Cloud for Life Sciences ensures that you have control over the configuration of your baseline environment and test changes to that configuration before going into production. Unlike other cloud providers, QAD enables customers to schedule patches and upgrades, enabling them to accurately assess risk and impact of any changes before deploying to the entire organization.

Stability and Reliability. Ensures that the instance of QAD Adaptive ERP for Life Sciences is delivered via a stable infrastructure ensuring reliability and accessibility to this critical business application.

Reduced Regulatory Compliance Burden. QAD Adaptive ERP for Life Sciences is operated in accordance with regulatory-compliant Standard Operating Procedures (SOPs), ensuring that the Qualified Environment is maintained in a demonstrable state of control and compliance.

Rapid Deployment. QAD Adaptive ERP for Life Sciences can be deployed at multiple sites across the globe without delay. This allows growing life sciences companies to adapt to changing market dynamics, add new users and locations rapidly and not be limited by technical or system resources.

For more information on how QAD Adaptive ERP for Life Sciences can help your company, visit the Life Sciences industry page.