On EZRentOut’s compliance with ALCOA and ALCOA+

EZRentOut is compliant with ALCOA and ALCOA+.

ALCOA and ALCOA+ are both data protection standards used by the FDA to verify data quality. The regulatory body uses these standards to check the integrity of both paper and electronic data pertaining to drug production, testing, and distribution.

The acronym embodies the data quality standards defined by FDA’s quality regulations (GLPs and cGMPs). While ALCOA was a term used internally by the FDA, it quickly became popular amongst many quality assurance professionals.

For this reason, ALCOA and ALCOA+ became the basis of data quality assurance in laboratory testing and drug production and distribution.

EZRentOut data completely conforms with ALCOA and ALCOA+. This development means that all data related to orders and assets in EZRentOut is accurate, traceable and reliable.

Pharmaceutical and healthcare companies using EZRentOut have access to authentic audit trails for all inventory items so any chances of data discrepancies can be weeded out.

What does ALCOA stand for?

ALCOA is an acronym which stands for:

• A: Attributable
• L: Legible
• C: Contemporaneous
• O: Original
• A: Accurate

So what do these terms mean for data stored in your EZRentOut Account?

Attributable: Attributable data is verifiable, or simply put, should be linked to its source. This means that all data records should be linked with the individual’s name and the time of data entry.

How is EZRentOut Data attributable? All data entries in EZRentOut are recorded with their time stamps and the creator’s identity. This automatically generates an audit trail so records can always be double-checked and accountability is never a problem.

Legible: To be considered legible, electronic records should be readable over screen or printable. There should also be a means to read digital data, either over the screen or in a printout.

How is EZRentOut Data legible? All electronic records in EZRentOut are easily readable. You can also export data records and print them when required.

Contemporaneous: All occurrences should be recorded in the software as soon as they take place. This means that all transactions should be recorded when they transpire and all data changes should be entered as soon as they’re observed. In this manner, the timestamp would indicate exactly when the change happened.

How is EZRentOut Data contemporaneous? While inventory data like stock levels, service activities, and asset assignments is automatically updated, the responsibility of logging data in a timely manner falls on the shoulders of the users. To make data contemporaneous, companies need to encourage diligent data recording amongst their employees.

Original: Records should be preserved in their original form and authentic copies should be specified as such. This also implies that data cannot be deleted or modified unless originals are preserved in some form.

How is EZRentOut Data original? All created records are maintained in their original form and any modifications are highlighted. You can view these changes in the history logs. Furthermore, you cannot delete orders, assets, or members that are linked with EZRentOut activities. You can instead deactivate members to ensure their data remains unaffected. This makes preserving original data possible.

Accurate: All records should be entered honestly, to the best of the individual’s knowledge, and should be complete.

How is EZRentOut Data accurate? While automated records are accurate and cannot be unchanged, employees should be encouraged to record updates honestly. We advise stressing upon the value of accurate data in your company to promote honest data reporting at your company.

What additional attributes does ALCOA+ cover?

The plus in ALCOA+ includes four additional attributes of quality data. These refer to data being complete, consistent, enduring, and available. Here is what this means for your EZRentOut data.

• Complete: data should be recorded in its complete form and nothing should be missed out. All processing and modifications should be recorded.
  EZRentOut records all updates and changes in orders, bookings, and services.
• Consistent: data should be coherent throughout and should not contain any discrepancies.
  EZRentOut audit trails are consistent.
• Enduring: data should be preserved in a durable form and only where it is supposed to be recorded (digitally/on paper).
  All EZRentOut data is recorded in the software and saved on the cloud.
• Available: data should be easily accessible.
  All modules and data in EZRentOut can be easily accessed via a user-friendly dashboard. The mobile app makes it easy to pull up data even when away from the office.

These additional attributes ensure that all processes revolving around data entry are carried out with great care.

Ensure you are always compliant with FDA’s data standards

While EZRentOut ensures that your data is protected, it is necessary for all concerned users to know about the ALCOA and ALCOA+ standards. Only when they know the right method of data logging will they enable your company to be in line with FDA’s data quality standards.

For this reason, true compliance comes when users log data with care and make a conscious effort of keeping data integrity intact.

EZRentOut is the complete rental software that allows companies to manage their orders, assets, users, and stores. For help or further information, shoot us an email at support@ezo.io.