QEdge -Full Product Quality (PQR)
Pharmaceutical companies are required to submit a full Product Quality Review (PQR) or APQR in the U.S. and PQR in Europe to government health authorities annually, detailing key aspects of the manufacturing process for each drug they produce. APQR or PQR is a mandatory requirement that used to verify the consistency and appropriateness of an existing manufacturing process. It plays a critical role in identifying any trends in the process further leading to process or product improvements. It is an evaluation which is prepared according to the CGMP requirements of different regulatory authorities. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product the content.
- Auto generates Product Quality Review (PQR) document for every product manufactured as per the predefined template based on the selection of the start and end date
- Auto Alerts in case of delays or upcoming activity
- Dashboard can be designed at each profile user with respect to every activity that provide intelligence regarding each parameter
- Allows users for controlled auto versioning of PQR document
- In compliance with all major standards including 21 CFR PART 11 and EU Annex 11 Standards and defined by other regulatory bodies
- Configurable workflow design as per current practice
- Design and Configuration of master data
- Batch wise trending reports for key data
- Auto calculate Process Capability Index value
- Comparison of data between current and previous year/s
- Integrating with other software systems and any other ERPs
PQR goes beyond the basic regulatory requirements and provides users with organized analytics for critical functions. In doing this, it certainly promotes a value of continuous Product Quality Review. Below are a few benefits:
- Improved compliance and reduced operating costs
- Enhances accuracy, productivity and consistency
- Access trending, productivity and other metrics, instantly
- Improved decision making
- Readily available key analytics within minutes as and when needed
- Save massive amounts of time, resources, and effort
- Ensure data integrity
- Meet compliance standards set by regulatory authorities as all the data ingested is audit trailed for 21 CFR Part 11 compliance
- Benefited across various business domains like Pharmaceuticals, life sciences, biologicals, manufacturing and packaging industries, medical devices etc.