Data Reporting, Integrity and Compliance
To ensure the integrity and compliance of reported data, each laboratory should ensure the process from sampling to reporting is fully controlled.
Using technical controls in laboratory informatics solutions is the best way to achieve both data integrity and regulatory compliance.
Whilst designing electronic workflows, three principles of laboratory automation must be followed:
1. Data acquisition at the point of origin:
Always interface instruments to acquire analytical data
2. Never transcribe data:
All data must be transferred electronically between systems using validated processes to avoid making transcription errors
3. Know where data is stored:
This may involve location and file naming conventions so that data can be retrieved easily for audit or inspection quickly and easily
Data process mapping should be used to identify vulnerabilities in the process and well as process inefficiencies and by using the three automation principles above, the vulnerabilities can be eliminated as well as ensuing data integrity and regulatory compliance is achieved. This results in a more efficient and effective process.
Further examples upon the approaches involving sample preparation and chromatographic analysis will also be discussed.
Watch this webinar, to learn:
- How to ensure the integrity and compliance of reported data, from sampling to reporting.
- How to utilize technical controls in laboratory informatics to ensure integrity and compliance.
- The three principles of laboratory automation for designing effective workflows.