Maintaining Data Integrity During Digital Transformation

Pharmaceutical manufacturing is undergoing dramatic changes that impact the entire value chain. Driving this is the overarching shift to digital with several disruptive technologies. These technologies harness intelligence for better decisions and enhance the user’s experience via augmented and virtual reality. The direct benefit includes reduced cost of ownership and availability of information at any time from anywhere.

Manual Cleaning, Digitized

Pharmaceutical organizations are going paperless in a move to digitize quality and production operations. An example of this is sanitation. Objectives of this process include:
  • Automating capture of cleaning hold times and alerts for deviations
  • Reducing paper instructions and records
  • Enforcing work standards
  • Reducing manual entries up to 90%
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Sustained Alarm Management, Digitization and Regulatory Compliance

Reduce risk, time and costs associated with paper-based SOPs of critical alarms in SCADA and BMS systems. Enable the following goals related to compliance and digitization:
  • Avoiding  483 compliance issues
  • Complete documentation to assist audit observations
  • Satisfy quality system procedures
  • Alert non-conformance events
  • Enforce record review and approvals
  • Risk avoidance of batch loss
  • Alleviate delays of batch releases
  • Reduce operator errors
  • Enforce complete record-keeping
  • Timely approval for enforcement and governance matters
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Batch System Management

  • The system 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

Management of diverse electronic records that 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, as well as replace manual processes and paperwork with electronic workflows. It encompasses everything from routine operations and escalated responses to critical plant operating conditions.
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Data Integrity

  • Ensuring that cGMP related data is accurate, trustworthy, and reliable through the data life-cycle.
  • Also ensuring data, once recorded, cannot be altered
  • The AVEVA Historian is widely used in the life sciences industry for this purpose
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