Do you often struggle with data integrity, traceability and compliance in daily laboratory operations? Especially when complying with stringent regulations such as GMP and FDA requirements, efficiently managing sterilization records while guaranteeing they remain tamper-proof has become a core concern for many pharmaceutical enterprises and laboratory supervisors.
I. Intelligent sterilization, reliable data management
Standard GMP version: Fully meets basic functional requirements
Export data in tamper-proof format
Once generated, all sterilization records can be exported in a fixed format, preventing any modification or deletion, to smoothly pass domestic GMP inspections.
Advanced FDA version: hassle-free international compliance
1、Compliant with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures
2、Traceable and secure electronic records: full audit trails for every operation and each process node
3、Comprehensive activity logging: clear visibility of who performed an action, when it was done, and what the action entailed
4、Electronic signature function: identity verification linked to operations, legally equivalent to handwritten signatures
II. Four core advantages to solve your pain points
Tamper resistance: Prevent subsequent data alteration and guarantee the authenticity and integrity of original data.
Secure traceability: Full activity logging enables retrospective investigation of every step, ranging from equipment operating parameters to personnel operations.
Compliance assurance: Specially developed to meet GMP and FDA requirements for smooth audit readiness.
Efficient management: Streamline workflows and improve operational efficiency of laboratories.
ZEALWAY provides quality autoclaves, full services and professional sterilization solutions for you.
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