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