Validating pharmaceutical systems
Computer system validation also reduces long-term system and project costs by minimizing the cost of maintenance and rework.
Validation of HPLC system is most critical and important because all regulatory authorities focus on this instrument and different data integrity issues are found during FDA inspections.
This cautious approach to shiny new technology objects is more than appropriate given the high stakes nature of the good work these companies perform.
Mitigating risks and avoiding new ones is top of mind for pharmaceutical IT and quality professionals.
The data with some of the highest concerns for risk in cloud environments includes records pertaining to quality systems in pharmaceutical manufacturing.
Company requirements in these industries are extremely tight on computer system validation due to the need to stand up to the rigor of regulators.
User Requirement Specification: URS for HPLC system is prepared to describe the critical functionalities those are required for our analysis.
Following point should be considered during preparation of user requirement specification for an HPLC system.2.
For example, if data of HPLC is stored on the server then chromatograms and reports should be compared after printed on the computer system and on the server after storage and retrieval of data files.5.Now that cloud-computing models are well accepted across many industries with proven security models and high reliability, it is becoming a viable option for life sciences enterprises.However, the nagging challenge of validation of these systems is still widely misunderstood among life sciences professionals.However, the benefits of cloud-based deployments have ushered in a new class of Quality Management Systems (QMS) that have transitioned successfully to the cloud.Among those systems, thoughtful vendors have taken new approaches towards validation that not only meet the requirements but in many ways provides a higher quality output.
The data, screenshots and prints should be maintained.