Management of Original Environmental Sampling Data
The principles of ALCOA+ on Data Integrity in the pharmaceutical industry includes the need to save the Original Data from the process. As described in document PDA TR80 on Data Integrity Management Systems in pharmaceutical quality control laboratories, the primary environmental control data is the plate or jar of the culture medium from which the sample has been taken and has subsequently been incubated in suitable conditions for microbiological growth.
Obviously, we may think that this is an impossible requirement due to the nature of the samples and the changes in the results over time: the presence of microorganisms that will tend to occupy the entire volume of the plate or media which become dehydrated over time.
In most cases, colony count readings are manually transferred to forms or spreadsheets, but this written document cannot be considered as Original Data. To solve this problem, certain companies read the plate twice to corroborate the data, thereby increasing the time and labor cost in doing the readings.
On the other hand, in case of growth, once a sample has been handled, it is not possible to modify the appearance of the resulting place and the traceability of the colony identification may be lost.
SherpaPharma has enabled the camera function on the handheld device to be able to take a photo of the plate when reading the colony count. This prevents tampering with the images and enhances compliance with Data Integrity by adding images to your results.
Simplify documentation of your results with a photo, directly with your handheld cleanroom device for a reliable and effective Environmental Monitoring.
Enric Adserà has a degree in Chemistry, Chemical Engineering and MBA from ESADE. Since 2018 he works in Tiselab as Project Manager of SherpaPharma providing his experience and knowledge in the application of Environmental Monitoring solutions in the pharmaceutical industry.
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Enric Adserà es Licenciado en Químicas, Ingeniería Química y MBA por ESADE. Desde 2018 trabaja en Tiselab como Project Manager de SherpaPharma aportando su experiencia y conocimientos en la aplicación de soluciones de Monitorización Ambiental en el sector farmacéutico.
Enric Adserà has a degree in Chemistry, Chemical Engineering and MBA from ESADE. Since 2018 he works in Tiselab as Project Manager of SherpaPharma providing his experience and knowledge in the application of Environmental Monitoring solutions in the pharmaceutical industry.
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Enric Adserà es Licenciado en Químicas, Ingeniería Química y MBA por ESADE. Desde 2018 trabaja en Tiselab como Project Manager de SherpaPharma aportando su experiencia y conocimientos en la aplicación de soluciones de Monitorización Ambiental en el sector farmacéutico.
Enric Adserà has a degree in Chemistry, Chemical Engineering and MBA from ESADE. Since 2018 he works in Tiselab as Project Manager of SherpaPharma providing his experience and knowledge in the application of Environmental Monitoring solutions in the pharmaceutical industry.
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Enric Adserà es Licenciado en Químicas, Ingeniería Química y MBA por ESADE. Desde 2018 trabaja en Tiselab como Project Manager de SherpaPharma aportando su experiencia y conocimientos en la aplicación de soluciones de Monitorización Ambiental en el sector farmacéutico.