Maintaining Data Integrity While Digitisation and Transformation

Pharmaceutical manufacturing is undergoing dramatic changes that impact the entire value chain in the industry. Driving this is the overarching shift to Digital with disruptive technologies. These technologies harness intelligence for better decisions, enhances the experience via augmented and virtual reality. The direct benefit includes reduced cost of ownership and availability of information at any time from anywhere. Pharmaceutical organisations are going paperless in a move to digitise quality and production operations.
Manual Cleaning. Digitized
Objectives of this process:
  • Cleaning hold times tracking and alerts
  • Reduce Paper
  • Enforces Standard Work
  • 90% Entries Reduction
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Alarm Management. Digitization and Regulation. Sustained
Reduce Risk, Time and Costs associated with paper-based SOP’s dealing with critical Alarms in SCADA and BMS systems. Checks the following goals related to Compliance and Digitisation:
  • Help Avoid 483’s –Compliance Issues
  • Complete Documentation – assist Audit Observations
  • Satisfy Quality System Procedures
  • Alert to Non-Conformance
  • Enforce Record Review and Approvals
  • Risk Avoidance of Batch Loss
  • Alleviate Delay of Batch Release
  • Reduce Operator Error
  • Enforce complete record keeping
  • Enforcement & Governance - Timely Approval
  • Resource FTE Availability
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Batch System
A system that can be used for the most complex batching processes which require a high level of flexibility. Built-in security and material management capabilities including material consumption, movements, and inventory levels contribute to a comprehensive Electronic Batch Record (EBR) and reduce the cost to comply with industry regulations.
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Electronic Records System
Examples of electronic records include product and raw material specifications, bills of material, recipes, SOPs, laboratory instrument data, master production and batch records, equipment set up configurations and maintenance logs.
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Workflow Management
A system that provides the capability to manage, enforce and document processes cross-company, replacing manual processes and paperwork with electronic workflows. It encompasses everything from routine operations to escalated responses to critical plant operating conditions.
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Data Integrity
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. Ensuring that cGMP related data is accurate, trustworthy and reliable throughout the data life-cycle and ensuring once recorded, data cannot be altered. Stringent regulations are in place with the rise in violations. Global Regulators are focused on Data Integrity and more specifically about the data quality and data storage practices. From 2010 to 2012 – only 5 drug manufacturers were cited for data integrity violations. But from 2013 to 2015, 24 were cited and its only increasing.
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