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Data Rei — Quality IT Flow
IT

// industries

Where regulatory risk runs highest

We know the constraints of regulated manufacturing and the language inspectors use. We do not translate between IT and quality: we speak to both, because we answer to both.

Pharma

Drug manufacturing, packaging, serialisation. The most heavily regulated environment and the one where scrap costs most.

// typical systems

  • Electronic batch records (EBR)
  • MES and line supervision
  • QMS, deviations and CAPA
  • Serialisation and traceability
  • ERP and materials management

// recurring issues

  • Audit trail enabled but never reviewed
  • Shared accounts on line terminals
  • Unvalidated interfaces between systems
  • Production changes outside change control

Biotech & CDMO

Processes in scale-up, technology transfer, contract manufacturing with multiple clients' data to keep apart.

// typical systems

  • Process data management
  • Multi-client LIMS
  • Technology transfer documentation
  • Environmental monitoring systems

// recurring issues

  • Data segregation between clients
  • Over-broad access profiles
  • Client audits on shared systems
  • Retention periods differing by contract

Medical devices

Devices and software that is itself a device, with MDR and a technical file that has to stay current.

// typical systems

  • Design history file management
  • Software as a Medical Device
  • Component traceability
  • Complaint handling and vigilance

// recurring issues

  • Incomplete requirement-to-verification traceability
  • Management of third-party software
  • Documentation out of step with released versions

Laboratories

Quality control and analytical labs, where the raw data an instrument produces is the first thing an inspector asks to see.

// typical systems

  • LIMS and electronic lab notebooks
  • Chromatography and instrument software
  • Sample and stability management
  • Instrument-to-LIMS integration

// recurring issues

  • Raw data on unprotected local workstations
  • Manual reintegration without recorded justification
  • System clocks out of sync
  • Instrument backups never verified

Manufacturing

Industrial production with operational technology integrated into IT systems, where the two worlds follow different rules.

// typical systems

  • SCADA and supervisory systems
  • Line data acquisition
  • OT-IT integration
  • Planned maintenance

// recurring issues

  • End-of-support operating systems on machines
  • Flat, unsegregated plant networks
  • Uncontrolled vendor remote access
  • PLC backups missing or never tested

Your sector not listed?

The principles of data integrity apply wherever data is subject to external scrutiny. Tell us the context and we will say whether we can be useful.

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