iLabTrace
iLabTrace is a system that collects test and quality result data and ensures its traceability.
It complies with 21 CFR Part 11 and Data Integrity Guidelines and is designed to support regulatory compliance.
<iLabTrace Process>
<iLabTrace Workflow>
· Backs up test reports and files from analytical instruments to a central server.
· Works regardless of instrument type or manufacturer.
· Reports and files from multiple instruments can be organized into directories and managed on a central server.
· Audit trails make these files traceable.
Why You Need It
What's the essential?
The essential elements of
iLabTrace are as follows.
Regulatory Requirements
Provides results that meet US FDA or MFDS requirements for traceability of data and test reports.
Data Integrity
Audit trails record and track who changed data, when, what was changed, and why.
Raw Data Management
원본데이터의 수집과 관리 기능이 포함되어있어 영구적인 데이터 관리가 되며, Paperless를 지향합니다.
Key Features
데이터 위변조 방지
It prevents human error in advance and protects against malicious data falsification.
Greater Convenience
Initial setup enables standardization and makes operation and use convenient.
GxP Compliance
21 CFR Part11, Data Integrity
(Data Integrity) and other regulations, with automatic data collection.
Data Traceability
It is designed to accumulate and trace multiple types of data in a single system.
CSV ?
CSV (Computer System Validation) is a series of processes that evaluate whether a system has been designed and implemented in line with legal requirements.
CSV is legally required to introduce and operate a solution in a laboratory.
Drawing on extensive CSV experience, Bioconnect has a proven validation methodology and highly qualified GMP staff who perform validation to international standards, helping you expand into global markets.