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Digital Transformation solutions for Pharmaceutical Manufacturing

Digital Transformation solutions for Pharmaceutical Manufacturing

Many instrument logs like calibration report, logbooks for temperature monitoring, experiments logs etc are still in paper-based records. Having such a fast growth in mobile applications development, the companies should adopt to digital way of recording this data entry process, which helps in many ways.

electronic logbook

Advantages of Electronic logbook (Why do we need to adopt this digital process)

  • Simplify processes related to administration and use of validation documents, logbooks and forms 
  • Create forms and check lists with workflows for registration of GxP activities supporting batch release.  
  • It is very easy to track the GMP records during external audits
  • 100% reduction of paper and manual data entries, which comes with, automated system.
  • Records cannot be tampered or misplaced. Ensures data integrity
  • Real time data entry from assembly line.
  • Quick review and approval process.
  • Integration with QR code for traceability solutions
  • The solution will improve the quality of data for analytics and reporting and support the instant release of product.
  • Enable digitalisation such as analytics and Robotic Process Automation 

Digital Transformation using Mobility – Having android-based tablets at shop floor level.

electronic logbook process flow

  • Batch creation for a product is executed in ERP which will have the following (Batch code, Product, Quantity, Equipment  Batch Status)
  • Each equipment in the process flow is QR coded with equipment information like IQ date , next calibration date etc
  • The operator scans equipment QR code using mobile application. The mobile apps open the logbook that needs to be updated.

User does the following in the mobile apps

  • Scan the equipment /select the equipment
  • System shows the status of equipment with previous batch information.
  • Update the status with remarks (In use, To be cleaned, cleaning, Ready for use, Maintenance activity)
  • Perform the activity and update the logbook

Each entry will have a transaction id with approval flow. After the publishing of data, the review and electronic signature can happen in mobile as well as a web based application. System generates a PDF document with the signed information goes into a Document management system.

Equipment Dashboard

  • Web based application to have equipment wise status view
  • Shop floor will have thin client based system with a TV or Display unit. This display unit will show the equipment dashboard

Security Challenges – Mobile device management approach

  • To have an android based application at end user level will have lot of security challenges.
  • To solve this problem, we can adopt mobile-based device management tools.
  • Microsoft Intune helps to solve the security-based issues in an enterprise network. This also adopts all internal IT security policy and ensure the data security

I will explain how to adopt MDM based solution with a base architecture in a separate blog

 

AdventSys provides various digital services for the Life Science industry in the areas of pharma manufacturing and Computer System Validations (CSV). Pls feel free to approach us for a non-obligation quote for our solution offerings