CSV & Data Integrity

Ensuring that your computerized systems are compliant with 21 CFR Part 11 Electronic Records, Electronic Signatures, and Eudralex Annex 11. We have expertise utilizing the Good Automated Manufacturing Practice (GAMP 5) guidelines and ASTM E2500 for the implementation of a risk-based approach to Computerized System Validation.

Cloud 9 Consulting Ltd professionals can support you in the implementation, project management, equipment selection, commissioning, qualification, and validation of your computerized systems, including:

  • Distributed Control Systems (DCS)
  • Supervisory Control and Data Acquisition (SCADA) systems
  • Programmable Logic Controller (PLC) based systems
  • Building Management Systems (BMS)
  • Environmental Monitoring Systems (EMS)
  • Laboratory Information Management Systems (LIMS)
  • Implementation and qualification of track & Trace/serialization of packaged pharmaceutical products

DATA INTEGRITY

Data integrity deficiencies will impact regulated organizations which could result in significant financial implications as well as lost reputations.

The FDA utilizes the ALCOA principle.

  • Attributable:  Who performed the action and when? If a record is changed, who did it and why? Linked to the source data.
  • Legible: Data must be recorded permanently in a durable media and be readable.
  • Contemporaneous: The data should be recorded at the time the activity is performed and date and time stamps should follow in order.
  • Original: The information must be the original copy or a certified true copy.
  • Accurate: No entries or editing performed without documented amendments.

For new systems building ALCOA into the design specifications to ensure that the system will meet the Data Integrity requirements reduces the overall risk of non-compliance and failure. A collaborative approach with the system/equipment developer to implement suitable risk management, design reviews, change control, verification and acceptance testing are key to achieving robust computerized systems which meet the regulatory expectations for Data Integrity.

For legacy systems, a different approach is required:

  • GAP Analysis review of the system to identify areas of non-compliance.
  • Remediation of the system GAPs; can be implemented through control system software and/or hardware upgrades with robust test plans to verify the system functionality.
  • Where systems cannot be upgraded and in certain circumstances, interim manual controls can be implemented to provide a level of data integrity assurance; however, permanent automated solutions should be implemented.

Cloud 9 Consulting Ltd helps our customers to achieve Data Integrity compliance by offering the following services:

  • Legacy System Data Integrity Compliance Reviews.
  • Risk Management Implementation.
  • Interim Controls Implementation.
  • Data Governance Policy Implementation.
  • System Verification and Validation Documentation and Execution.
  • Data Integrity Inspection Readiness
  • Data Integrity Reviews.
  • Design Specification Services.