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8th October 2019  Content supplied by: INTERSCIENCE

How to Ensure your Data Integrity with ScanStation, Real-time Bacterial Monitoring


ScanStation, real-time bacterial monitoring unit, detects and counts colonies as soon as they appear at the beginning of the incubation for 100, 200 or 300 Petri dishes. It provides anticipated results for quality control labs in the pharmaceutical, agro-food, cosmetic industries and research with full data integrity 21 CFR part 11.

How does ScanStation work to ensure data integrity 21 CFR part 11?

ScanStation records all photos, videos of bacterial growth, results and comments of up to 300 Petri dishes in real-time. Passwords, user management system and roles are parametered and guarantee a secured workflow, analysis, results and reports. The accelerated growth video provides the ability to "go back in time" and helps validate the results, as the operator can review early images to determine the original number of colonies, identified by a green cross.

Moreover, 21 CFR part 11 enables a data management by 3 levels : manager / analyst / consultant. You can also create as many roles as you wish. The roles and applications of the levels are to be defined by the manager: setting, verification/validation of results. The traceability of the relevant chronological record of operation is guaranteed by the audit trail. This audit trail is an unalterable file that records all actions since the installation of the software with a user and time stamp and is accessible at any time.

The access to the loading door is also protected: the unlock button enables physical access to the loading door depending on the operator’s rights.

For data export: after validation by the manager, the results are exported in the report to images, videos, PDF. The export can be basic, detailed by colonies with the date and time, graphic, number of CFU….

The US FDA, EMA and CFDA have provided the following key principles to guide good industry practice on matters from routine data through to documentation and training named ALCOA :

  • Attributable: all data should be attributable to the instrument to the instrument and operator and dated.
  • Legible: data should withstand the test of time
  • Contemporaneous: data should be documented at its point of creation
  • Original: original should be retained
  • Accurate: the record should be an honest account of the facts.

ScanStation was designed to fulfill all these guidelines to ensure data accuracy, security and completeness.

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Multiple award winner :

  • Innovation Award Trophy (Productivity / R.O.I categories) – Forum Labo, Paris, France
  • General Public Award Trophy 2017 – Forum Labo, Paris, France
  • Design Observer Label 2018 – Observer du Design, Paris, France
  • Innovative Companies’ Trophy 2017 – Cci / La Montagne, Aurillac, France

Visiting the 14th Annual PDA Global Conference on Pharmaceutical Microbiology?  Find out more about ScanStation at Booth #400


    

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Date Published: 8th October 2019

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