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
a batch manufacturing process. Helps to streamline compliance procedures, improve
operational efficiency, and reduce human error in the production of pharmaceuticals.
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
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
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
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
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
acceleration through secure
digitalisation and compliance.