Caliber QPyramid-PQR

Caliber QPyramid-PQR

CaliberQPyramid-PQR is a highly sustainable reporting tool as it is built exactly as per the needs and long-term goals of the companies in the pharma industry. It adheres to 21CFR part 11 guidelines so that the data integrity of the transactional data is protected.

The architecture of the product makes it store large volumes of data and its structure helps to render any complex report within no time. It is configurable wherein any APQR template can be built and used.CaliberQPyramid-PQR is a highly sustainable reporting tool as it is built exactly as per the needs and long-term goals of the companies in the pharma industry.

It adheres to 21CFR part 11 guidelines so that the data integrity of the transactional data is protected. The architecture of the product makes it store large volumes of data and its structure helps to render any complex report within no time. It is configurable wherein any APQR template can be built and used.Product Quality Review is extremely important for any pharmaceutical company and becomes essential if it is exporting to US and Europe.

Applying appropriate critical analysis and interpretation of PQR will ensure potential product quality issues are not neglected, and also that you limit brand and financial risks of organisation (with possible product recalls).CaliberQpyramid helps pharma drug manufacturers to generate such important reports and helps to

  •  Verify the consistency of the existing manufacturing processes.
  • determine the quality and process defects of the products.
  • determine the defects and possible improvements of the methods and process.
  • Analyse the trend of yield, analytical results, manufacturing parameters of the product are also highlighted.
  • Review the quality of the raw material and packaging material which is used for the product. • indicates the quality of material.
  • Determine the consistency of the quality of the product, the in-process parameters and the finished product results are reviewed.
  • Review by trending the yield of every batch.

The CaliberQPyramid goes beyond the basic regulatory requirements and provides users with ready-on-demand analytics for crucial functions which promotes a culture of continuous, ongoing Product Quality Review.

This helps companies improve the quality of their product with a steady, ongoing process. CaliberQPyramid-PQR is a system that can help sustain the quality of products in a more consistent and steady manner which will ensure that lesser time, efforts and energy is wasted.

This initiative is well accepted and is here to stay, the industry is moving towards paperless in all quality areas and CaliberQpyramid is the answer to it.

Caliber APQR is an analytical reporting engine with built in data warehouse which essentially combines information from Quality department sources like LIMS, Quality Assurance Systems, Batch Records, SOP, procedures, Analytical instruments data, product related data from SAP or any ERP, any other external files like excel, or any API.

The data from various sources will be extracted with audit trail. The cleansed data will be arranged in Data-Marts which will have an access layer though which the users can view Department Analytics for each division. The relevant PQR data will be collated in a data warehouse as a repository. State of the art reporting tool will enable the user to build their own cubes, drilldown reports.

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