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OpenLAB CDS Data Integrity

Data integrity in labs today: What you need to know

Data integrity issues in analytical laboratories are driving more regulatory
action than ever before. Staying current means continuous monitoring and
updating of your instruments and software, as well as ongoing education
for your staff. Taken together, these help ensure compliance, mitigate
regulatory exposure, and prepare you for your next inspection.

View our webinar, Data Integrity in Pharma QC Labs.
What you need to know

View our webinar, Data Integrity in Pharma QC Labs.

ALCOA+: The criteria that define data integrity
The criteria that define data integrity

To meet regulatory requirements, your laboratory data must be:

Attributable
to specific staff members via audit trails and eSignatures
Legible
for internal reference and audits, as well as regulatory inspections
Contemporaneous
so that data is recorded at the time that work is performed
Original
retained in the format in which they were originally generated
Accurate
using a system that minimizes errors, ensuring that raw data and analytical results are correctly presented
Complete
making sure everything is included, and nothing is missing
Consistent
based on a system that enforces use of approved data acquisition and analysis methods, reporting templates, and laboratory workflows
Enduring
using media that ensure records are maintained and protected
Available
so that records are accessible as needed

OpenLAB CDS puts ALCOA+ into action

Take advantage of Agilent’s expertise and advanced technical controls in our data systems to address ALCOA+ standards and drive data quality and data integrity in your lab.

The best defense is proactive, robust data security

Records protection — OpenLAB software provides secure data storage.
After acquisition or processing, the software automatically stores all
methods, data, and reports in a secure repository. What’s more, the
software automatically extracts and indexes relevant information, such
as sample name and operator, to expedite future retrieval.

Go paperless with online review of records and audit trails

Audit Trail Review – Other chromatography data systems require you to
maintain hybrid records for audit trail reviews that still have to be printed
and signed. With the newest release of OpenLAB CDS, you can now include confirmation and documentation of audit trail reviews as part of the electronic record. Plus, you can review records and audit trails in parallel.

Make sure you leave a permanent mark

eSignature — OpenLAB CDS permanently links electronic signatures to
records, embeds them in the final result, and makes sure they’re present
whenever the records are displayed or printed. All of which speeds
reviews and approvals, and ensures that the appropriate staff members
have signed off on reports in the proper order — all while saving paper
and reducing hard-copy management.

Ensure that the right people have the right access to the right information

Access Control – OpenLAB CDS enables you to assign privileges based
on the type of user and the data they need to access.

Eliminate reporting errors

Reporting – Create reports without the need to export results into other
software, such as Microsoft Excel. Even better, built-in custom
calculation capabilities keep all key data within the system—eliminating
errors caused by data export or manual transcription.

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Compliance and ease of use, together at last
The future is here, and we designed it for your lab
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Software you can trust

For analytical labs like yours,
OpenLAB CDS delivers the
highest level of data integrity–
and peace of mind.

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The ideal chromatography data system

This new LCGC e-book considers what functions and features should be available in an ideal chromatography data system (CDS) for use in a regulated analytical laboratory.