Achieving calibration data integrity with ALCOA & ALCOA+ principles this 2023
Updated: Feb 25
We live in an era, where data is everything! With the laboratories relying on various management software and spreadsheet tools to manage their day-to-day operations, how can we ensure that the data readings that are maintained by the laboratories can be trusted?
Across laboratories, the records collected, or data become legal records when these data values are used to support a regulatory function.
Now, to ensure that these records are trustworthy and reliable, it is compulsory that they must comply with ALCOA principles.
Now, let us deep dive into what ALCOA stands for in detail and how Metquay - Calibration management software strives to ensure that these guidelines are met and maintained.
This term focuses on ensuring that the identity of the person creating a record is documented. When documenting the record in a paper trail, this is ensured with the help of signatures and names. Documents should be password protected and accessibility should be controlled.
Metquay has the feature of electronically uploading signatures and other identification details to ensure that each record is attributed to a user. Admin privileges help map users to the corresponding privileges within an application ensuring that only the relevant information is accessible to a particular user.
All records documented should be well-versed in both written and readable format. When documenting using paper trails, this must be ensured. Nonlegible records will be deemed void, as they sway away from meeting regulatory requirements.
Metquay provides a top-notch digital platform wherein data can be captured without any ambiguity. Our ‘Worksheets’ and ‘Procedure’ features ensure that admins can set the precedent or design that the technicians can follow when capturing data and this helps maintain the data capture with better clarity and segregation.
All records must be documented at the exact time the readings are taken. This ensures that no records are missed, or readings from memory become erroneous in most instances. The timestamp imprinted onto documentation helps ensure that.
Metquay ensures that the timestamp is rightly captured at the time of data entry itself, so as to ensure that there is no manual form of corruption possible.
When capturing data, every original piece noted should be documented. For every other piece of data that must be replaced or deleted, should be captured separately. There should be a proper distinction and all readings, whether correct or incorrect must be documented.
Metquay features give users the flexibility to design their data capture modules. This can include ‘Repeat’ fields, wherein data captured at each iteration can be noted down whether they are correct/incorrect. They are also given the flexibility to choose and repeat their readings during the design phase itself.
Data that is captured and stored should be with great precision and validity. Safeguard measures are often implemented to ensure that this is achieved. Documents are often signed off by respective approvers with higher authority positions and reminders are sent out to validate the entries.
Metquay provides the feature, wherein before a certificate is generated, it can be marked for approval, which then instigates the approver to give a go-ahead, before the final step of generating a report or certificate. This safeguard ensures that the data captured is accurate and multiple authorities sign off after designated checks!
Additionally, in 2010 the ALCOA principles also incorporated the below terms which makes it ALCOA+
This feature ensures that the information provided is complete and all corresponding information is present. It is made sure that data and operator actions are recorded in the same data file as part of an audit trail feature.
Whether all the data recorded is consistent in a sequential manner. All data is tagged chronologically and stored with the corresponding timestamp so as to ensure no data is missing.
The data captured remains safe which is a great challenge when maintaining paper trails for documentation. Digital storage solutions address this very problem and ensure data safety and storage endurance are met.
When paper trails and documentation become huge, there should be sorting and filtering mechanisms with which data access becomes easy and becomes readily available.
Metquay - Calibration management software is no less than your co-pilot before a flight, as its feature-rich domain help assist data capture and calculations with the utmost precision to help make your flight smoother.
If you would like to know more about the digital transformation possibilities of your calibration business, feel free to ping us at firstname.lastname@example.org. We are here to help you.