Pharmaceutical & Biotech
Strict Compliance and Validation, Simplified
Strict Compliance and Validation, Simplified
In pharmaceutical manufacturing, adherence to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP) is non-negotiable. A minor deviation can lead to batch rejection, regulatory fines, or patient safety risks. Operators must navigate complex validation protocols and change controls, often slowing down production to ensure compliance.
Situation: An operator is setting up a bioreactor and notices a discrepancy in the pH sensor calibration reading.
The operator halts the process, leaves the cleanroom to find the latest version of the calibration SOP, and consults with a Quality Assurance officer to verify the acceptable range.
The operator asks the cleanroom-ready tablet:
The AI confirms: "Yes, for Product X, the acceptable pH range at step 4 is 7.10 to 7.20 as per SOP-BIO-005 Rev 3. Proceed to step 5. Note: Ensure temperature is stable at 25°C."
Ensure operators always follow the latest approved procedures. Eliminate the risk of using outdated documents.
Accelerate equipment validation and change control processes with instant access to protocols.
Catch deviations early and correct them before they impact product quality.
Onboard new operators faster by providing them with an intelligent guide to complex GMP requirements.
See how Digital Twin AI can support your pharmaceutical manufacturing.
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