Computer software applications are widely used in pharmaceutical companies, to support a range of functions such as product development and manufacturing, through to the lifecycle of licences and drug safety reporting.
Software systems are fundamental to achieving consistent, reliable and accurate data across key functions - including regulatory affairs, which places greater the emphasis on ensuring these systems are validated. Samarind RMS is validated to GAMP 5 best practices and facilitates 21 CFR Part 11 compliance.
The validation process begins when a regulatory department identifies a need to implement a software application/computer system and follows a logical process covering vendor selection, the technical implementation and operational performance. The validation process will continue until a system is retired from use and the associated legacy data has been successfully migrated to a new system.
Validation can be a daunting and time consuming process, which is sometimes best left to an expert independent consultant. Samarind works with a number of expert regulatory consultancies to support its clients through the implementation of Samarind RMS.
For further information please contact us.