Premier Laboratory Informatics ExpertsStrategic Planning Implementation Validation

Keeping your SDMS fine-tuned and user friendly

Christopher HahnValidation Consultant

© 2017 CSols, Inc.

CDS vs SDMS

CDS = Chromatography Data Systems Distributed systems that acquire, process, report and store

data from Chromatography Systems, often across many labs and many sites.

SDMS = Scientific Data Management System Backup, store and retrieve your non-CDS data from

standalone instrument systems Dedicated computers loaded with COTS applications Instrument Examples: Spectrophotometers, FTIR Systems,

Particle Sizers, Endotoxin Plate Readers

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SDMS is a Critical Informatics Tool

Your CDS retains your Chromatography Data, but what about the rest of your lab’s data?

Regulatory Agencies (FDA, EU, etc) require that all data supporting commercial products be retained in both human readable and electronic format (CFR 211.180)

A SDMS is great solution when used effectively Configuration Administration Procedures

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© 2017 CSols, Inc.

Configuration

Manage your standalone scientific data not user manuals, vendor PDFs, internal SOPs or other

non-data file types. Segregate GMP and non-GMP data Use logical search filters

Company Site (assuming more than one) Laboratory Locations (where the data was generated)

And meta tags Instrument Type Asset ID, Serial Number & Manufacturer

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Configuration

SDMS Scan Lines Must be configured for each standalone instrument

system Indicate how often to sweep your standalone instrument’s

computer for only your scientific data Each instrument’s software and data directory structure

are different so a one size fits all approach will not work

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Configuration

Some types of SDMS scan lines should include your standalone instrument’s: Raw Data Files Calibration Data Files Method Data Files Sequence Data Files Report Files Audit Trail Data Files

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Configuration

Don’t just set it and forget it Frequently check your SDMS repository

Consider using other storage solutions for non-scientific data Network Drives Storage Area Networks, etc

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Administration

Perform Annual Reviews of your SDMS How often do you backup your standalone data?

Every 15 minutes, nightly, weekly, etc. Overwrite or append to the backup server?

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Procedures

Process for adding, modifying and removing standalone systems to your SDMS

Periodic review process for ensuring the hard disks are still being swept to match your original Scan Line configurations

Process for swapping out standalone instrument computers and/or other critical hardware

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Closing Thoughts

Always keep your SDMS lean and fine tuned, this will serve many purposes: Easier to restore lab data in the event backed up data is

needed Minimize your ever growing need for more server disk

space Faster and more meaningful data restorations

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© 2017 CSols, Inc.

Closing Thoughts

Always keep your internal customers needs in mind Regulatory Inspections Regulatory Filings Laboratory Investigations & Deviations Hardware/Software Failures

With thoughtful configuration, administration and procedures, your company’s SDMS will become an invaluable informatics tool for your laboratories

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Christopher J. HahnValidation Consultant

www.csolsinc.com