GxP Compliance through digital transformation

Pharmaceutical companies operate in one of the most dynamic environments. Mandate to regulatory standards by leading bodies such as USFDA, EMA etc. has increased the significance of regulatory compliance management for drug manufacturers. Pharma companies across the globe are compelled to alter their compliance practices to conform to the changes in regulations and stringent quality control norms however execution of the compliance norms in manual way is the most challenging task.

Best Blend of GxP Expertise with Technology Solutions for Remedial Action

Compliance to GXP standards is the primary focus for the Pharmaceutical industry. Changes in regulations by leading bodies such as USFDA, EMA etc. have increased the significance of regulatory compliance especially for the industries in exports.

TiMAD IT Solutions along with the QualiCulture Consulting Group (Regulatory Compliance Experts) came up with an exclusive solution offering by blending the GXP expertise along with technology to help pharma companies address the key compliance challenges through process automation and digital transformation.

Our Transformation Solutions for pharma industry:
• Plant Maintenance Mobility
• Calibration Mobility
• Intelligent Logbook
• Manufacturing Compliance Management Systems
• Disinfectant Preparation
• Intervention Management System / Sterile Manufacturing

Our Value Added Services for pharma industry:
• ERP Implementation
• Resource Augmentation
• Custom Application Development
• IoT and Cloud
• Predictive Analytics

PLANT MAINTANANCE

Make Plant Maintenance process compliant with with your Organization’s Process Standards (ISO, USFDA, FDA etc) with TiMAD’s Computerized Maintenance Management System (CMMS).
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CALIBRATION MAINTENANCE

Organize, Standardize and Digitalize the Calibration Maintenance process to be complaint with 21CFR Part 11 regulatory requirements.
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INTELLIGENT LOGBOOK

Organize, Standardize and Digitalize the Log Book Management process to be more user friendly and efficient. Also build data analytics on this data to derive meaningful results for future actions.
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LABORATORY INFORMATION MANAGEMENT SYSTEM

Comprehensive solutions to digitally transform the entire Laboratory processes to minimize manual errors and increase the accuracy in maintaining the Laboratory Analysis data/records.
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QUALITY MANAGEMENT SOLUTION

Managing the changes around product life cycle, resulting out of the Incidence, deviations, Change in SOPs, Market Complaints etc. is very cumbersome in the current manual process.
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ASSET MANAGEMENT

Manage your Assets with more sophisticated way by maintaining Asset Details, Warranties, Maintenance schedules, Asset Tagging, Physical Location, Expiry etc. through out the Asset lifecycle.
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RFID Enabled Stock Management

USE LATEST TECHNOLOGY TRENDS IN WAREHOUSE OPERATIONS Specially designed mobility solution for Warehouse Staff, Enabled with RFID, QR Code and Bar Code
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