CSV Solutions offer a range of services to help life science company’s validate their computerised systems. We specialise in offering these services for information systems such as LIMS, ERP, Quality Management Systems and Databases.  We can help you from defining the validation strategy through to execution of validation testing and reporting.  Using our risk management tools to aim to reduce the validation effort and cost whilst maximising the benefit for your business and ensuring compliance with the requirements of your regulatory bodies.

 

Some of the services provided include;

• Validation Project Management and Consultancy - Our experts can manage your validation projects and provide guidance on development of a validation strategy.
• Gap Analysis—21CFR Part11 - Based on current FDA thinking on 21CFR Part 11 we can assess you computerised systems for compliance to electronic records and signature requirements and provide solutions for remediation.
• Validation Documentation Generation - All validation documentation can be generated from user requirements, validation plans through to qualification protocols for your systems.
• Validation Test Execution - Our experienced resources can execute validation testing of your systems, report on errors found and outcomes of the validation testing.  We can assist in the implementation of automated testing tools.
• Computerised System Supplier Audit - We can perform audits on your external and internal suppliers of computerised systems to ensure their software development processes are sufficient to meet the needs of GAMP.

Where feasible we perform work remotely, reducing the costs to your business and ensuring that our senior personnel have input into the work produced.

 

GxP Computerised Systems Implementation

Having just purchased a GxP computerised system many companies are faced with the daunting task of getting that system into a state that it can be used by its end users.  Often this means a large amount of data entry, writing Standard Operating Procedures, System Configuration, development of reports etc.  CSV Solutions uniquely offers services to get such systems ready for use.