On-site system validation for studies performed in a GLP environment
fda 21 cfr part 11 assessment - gxp - computer system validation - software validation
emka TECHNOLOGIES’ systems are developed with high-quality assurance standards and have built-in features which allow them to be successfully validated. We do not, however, limit ourselves to the development of "validation-ready" systems.
We know that introducing a new software application into an organization working in a regulated environment involves many complex business processes. One major process involves validating the application in the client’s environment. The process can be tedious and time-consuming. Many companies do not have the time or resources to dedicate to a validation project.
We offer an array of support services to facilitate our customer’s "on-site" system validation. In order to establish the system’s accuracy, stability, and reliability, we can help you test your system as a whole for a specific system configuration, under specific operating procedures, and within a specific operating environment.
As the system provider, we are knowledgeable on how the systems operate, thus, we can provide effective validation assistance through our validation support service packages:
• support to customer and/or third-party package
• sample plan and test script models package
• tailored models package
• full validation process package
emka TECHNOLOGIES provides regulatory compliance & validation services for the the entire validation proces.
We can help you lower validation costsusing methods such as risk analysis, gap analysis and impact assessment inrelation to the relevant GxP guidelines.
1- regulatory compliance in the life sciences industry
We can assist you in meeting the increasing demands and complexity of national and international regulations. Our validation teams stay up-to-date through collaboration with international companies and ongoing contact with regulatory authorities.
Focusing on regulatory developments and validation activities consumes time and resources that you need to speed your products to market. Our team will help you take care of validation strategic planning.
2- computer systems validation
Our validation program covers:
• validation master plan
• risk assessment
• traceability matrix
• user requirement specifications
• functional requirements specifications
• installation qualification
• operational qualification
• performance qualification
• standard operation procédures
• validation documentation
3- validation outsourcing
Outsourcing allows you to meet the periodic validation requirements of your organization, while optimizing use of in-house resources.