Data Integrity: Connecting the Dots

Data Integrity: Connecting the Dots

Across the life sciences industry, data integrity has always been essential to quality control – and regulatory compliance. But as the pharmaceutical supply chain has become more global and diffuse, maintaining complete, consistent and accurate data throughout the manufacturing lifecycle has become more complex.

Today, life sciences companies typically rely on contract manufacturers for the active pharmaceutical ingredients (APIs) in their products. Yet an increasing number of cases citing poor quality data uncovered during API audits have sounded the alarms.

Violations range from poor records and deficient production process systems – to escalating instances of “testing into compliance” or performing multiple laboratory tests until a sample passes.

The industry response? New data integrity guidance from regulatory agencies including the EMA, FDA and World Health Organization, with harmonization of these standards an ongoing priority.

For pharmaceutical companies, an API violation can lead to production delays and drug shortages – and negatively impact public health and profitability. To help mitigate compliance issues, drug companies are requiring suppliers to apply more stringent quality controls – and expand their use of electronic records and technology.

But is an Electronic Batch Record (EBR) the Answer?

While an EBR automates metadata collection and reduces human error, it does not intrinsically protect against undocumented or malicious changes to that data. But an EBR integrated within a manufacturing execution system (MES) and deployed across a Connected Enterprise can help pharmaceutical suppliers maintain data integrity throughout their process.

How? A robust MES, like Rockwell Software® PharmaSuite®, supports data integrity through validation measures including:

  • Testing and monitoring interfaces with other systems.
  • Consistency checks during recipe design and execution.
  • Embedded weigh and dispense management.
  • Status management of recipes, workflow and equipment.
  • Automatic recording of changes to electronic records.
  • Systems rights configuration for appropriate user access and restrictions.

To help ensure a single data source and consistent workflows across the enterprise, an MES can be integrated with the automation, Laboratory Information Management (LIMS) – and ERP systems.

Simply put, a validated system – combined with a high level of integration – promotes a high level of data integrity.

Learn how new PharmaSuite capabilities enhance integration and lifecycle management – and ease compliance.

And discover why so many Fortune 500 life sciences companies rely on Rockwell Automation solutions.

Stefan Muench
Posted April 12, 2017 By Stefan Muench, Quality Manager, Rockwell Automation
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