Peace of mind with

MiraCal P

Compliance with the

Data Integrity Guidelines made easy Data integrity requires data to be complete, consistent, and accurate throughout a complete lifecycle, providing full transparency and traceability. Industry guidelines about data integrity, used by the FDA, WHO, PIC/S and GAMP, are described within the acronyms ALCOA and ALCOA+. MiraCal P analytical software from Metrohm Raman gives you peace of mind, as it ensures all data processing adheres to stan-dards stipulated by ALCOA and ALCOA+.



ALCOA

02

• Attributable – who performed which action

• Original – is this the first recorded observation

and when?

or a verified, true copy?

User management in MiraCal P, with automatic ar-

MiraCal P clearly displays both raw data results and chiving and accessible audits, enables straightforward processed results, identifying original and subsequent tracking of what actions were performed, when, and data based on version number. Each measurement has by whom (e.g. time and date, user, data acquisition a unique digital signature and the encrypted database and configuration changes).

prevents manipulation of data.

• Legible – does data remain readable

• Accurate – is data stored correctly and are

through out the complete lifecycle?

modifications clearly documented?

Whenever data are generated, MiraCal P makes MiraCal P provides necessary metadata for all data it possible to export the data to a local database or in order to identify the context (e.g., name of the external memory in PDF, CSV, or XML format. The user method, instrument hardware, or acquisition para-is responsible for archiving the data in a permanently meters), the meaningfulness of the data (e.g., Pass/Fail readable format.

results with statistical support), date and time. Configuration changes are validated by the required approval

• Contemporaneous – are records created at

of the system administrator.

the time of the activity?

The

MiraCal P audit trail records all activities from all users by creating a data record with the names of the user and client, the action, date, time, and difference to UTC.





03

ALCOA+

ALCOA guidelines were recently updated to in-clude features such as completeness, consistency, and availability of data.

• Complete – are all relevant data stored?

• Enduring – does stored data remain avail-

All data is automatically stored in MiraCal P’s data-

able for the duration of the required retention

base, including information required to create the



period?

record, including metadata and changes. The audit Whenever data are generated, MiraCal P makes it trail provides information about all activities required possible to save data in the database in many formats.

to obtain the data.

Subsequent versions of MiraCal P are able to read data created in earlier versions.

• Consistent – can the operation workflow be

reconstructed?

• Available – is data accessible / readable /

In

MiraCal P all configuration changes and measure­

printable?

ments follow a consistent and easily searched se-

MiraCal P records and audit trails are always avail-quence of events that is logged with color coded time able and can be easily reviewed using integrated moni-and date stamps.

toring features. Records and audit trails can be easily checked, exported, and printed at will.

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