Pharma
Ensuring 100% data integrity and GxP compliance. We bridge the gap between production and quality assurance with validated automation systems.
DEEP DOMAIN
EXPERTISE.
Industry-specific Logic
Pharmaceutical manufacturing is the most regulated industrial environment on earth. At ASKworX, we don't just automate pharma lines; we validate them. Our systems are built from the ground up to comply with GAMP-5, 21 CFR Part 11, and ALCOA+ principles. We ensure that every shift in temperature, every batch weight, and every operator action is logged in an encrypted, immutable audit trail. By integrating electronic batch records (EBR) directly into the SCADA layer, we eliminate the risks associated with manual paper logs and vastly reduce batch release times. In a field where data integrity is as critical as the product itself, ASKworX provides the security and transparency that global auditors demand.
Cleanroom Visibility
Integrated differential pressure and particulate monitoring in real-time.
Serialization
Track-and-trace integration from ground-to-distribution via secure cloud relay.
THE CHALLENGE
Strict Regulatory Guardrails
Maintaining absolute 21 CFR Part 11 consistency.
Data silos between production floor and QA labs.
Inconsistent batch report generation leading to delays.
THE ASKWORX SOLUTION
Validated SCADA with biometric user logins.
Automated Electronic Batch Records (EBR).
Environmental monitoring for storage stability.
Full CSV (Computer System Validation) lifecycle.