Driving GMP Compliance with Ci-DMS
No matter where you are in the supply chain, it is essential that you not only comply with good manufacturing practices but also provide irrefutable evidence of compliance.
Identifying compliance risks
Paper-based systems make root cause analysis difficult. When errors occur, additional manual checks are often introduced to compensate, increasing workload without addressing the underlying issue.
Ci-DMS records every process step in detail. Supervisors can review audit trails and structured reports to identify where deviations occur and where process weaknesses exist.
This enables targeted corrective action rather than reactive patchwork controls.
Ensuring Procedural Conformance
Manual processes provide limited assurance that operators consistently follow standard operating procedures.
Ci-DMS embeds approved work instructions directly into the workflow. Operators are guided step by step. Data entry validation confirms that required fields are completed correctly. If a deviation occurs, the system prevents continuation until authorised personnel review and approve the action.
This approach supports controlled execution rather than retrospective box-checking.
Supporting Validation and Audit Readiness
Ci-DMS includes a complete audit trail designed for healthcare manufacturing. The system supports electronic records and electronic signatures in line with regulatory data integrity expectations.
Classified as GAMP Category 4 configurable software, Ci-DMS is deployed across multiple regulated sites. Validation activities, therefore, focus on site-specific configuration rather than software redevelopment.
CI Precision provides documentation and project support to assist with validation planning, protocol development, and implementation.
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