Hand-written data entry in paper logbooks is error-prone and requires enormous time and effort. Associate spend hundreds of hours generating, reviewing and approving logs, then waste more time trying to retrieve the information, which is often stored in different physical locations, during audits and inspections.

We understand the challenge of stringent regulations and needs for becoming compliant. SMHS's Electronic Batch Manufacturing Record digitally tracks all of the elements associated with a batch manufacturing process. Helps to streamline compliance procedures, improve operational efficiency, and reduce human error in the production of pharmaceuticals.

Compliance Risk
  • FDA 483 Threat - Inaccurate paper logbooks can lead to deviations, Form 483 observations, warning letters, and even regulatory fines and sanctions
  • High probability of human errors - Mistakes are inevitable because of the sheer volume of information maintained in log
Operational Inefficiency
  • Reduced Productivity - It's time-consuming to physically (and methodically) record the date, time, product and lot number of each batch for equipment usage logs. Logging the required cleaning data is equally tedious. Manual log management takes a severe toll on productivity
  • No Insights - There is no structured data available for analysis and performance improvement. Data compilation is tedious

Our Approach

SMHS's eLogbook solution converts error-prone, time-consuming hand-written data entry in paper logbooks to 21 CFR Part 11-compliant digital harmonized logbooks, that helps create centralized data repository for analytical decision-making.

  • Harmonization: Setting up CoE within plants to harmonize logs which can be deployed horizontally.
  • Data Standardization: Master data for equipment, activities standardized for digital analytics enablement.
  • Deployment of Logs: Configuration and Development of logbooks with controls to enforce compliance.
  • Data Analytical models to provide details on golden time and micro breakdowns.
  • Data Integration with SAP or other business systems for keeping single point of truth.

21 CFR Part 11 Compliance

Data integrity - enforce legible & dependable data

Digital Compliance

Standardization - GDP Practice

Granular data for OEE improvement

Insights on capacity release

Accurate reproduction of data

Centralized data repository to enabled analytical decision for better productivity and performance of plant

Driving sustainable, enterprise-wide performance acceleration through secure digitalisation and compliance.
Get More details