Peace of mind with

MagIC Net

Compliance with the

Data Integrity Guidelines made easy

Data integrity requires data to be complete, consistent, and accurate throughout their complete lifecycle, thus providing full transparency and traceability. Industry guidelines about data integrity, used by the FDA, WHO, PIC/S and GAMP, are de-scribed within the acronym ALCOA and ALCOA+, respectively. Our chromatography software MagIC Net gives you peace of mind, as it ensures all data to have the following qualities stipulated by ALCOA and ALCOA+.





02

ALCOA

• Attributable – who performed which action

• Original – is this the first recorded observation

and when?

or a verified, true copy?

MagIC Net stores in the database and in the audit trail MagIC Net identifies the original data based on the the name of the person performing the task, together version number of the original record. The original data with the date and time of each action. (Data creation, are always kept (original version) even after changes data modification, login/logout attempts, data retrieval, ...) have been made (different versions). There is direct access to the last or all revised versions via a version

• Legible – does data remain readable

history depending on the configuration.

through out the complete lifecycle?

Whenever data are generated, MagIC Net makes it • Accurate – is data stored correctly and are

possible to export the data to the network or an exter-

modifications clearly documented?

nal memory in PDF, CSV, SLK, CDF, or XML format. In MagIC Net provides the necessary metadata for all this case, the user is responsible for archiving the data data in order to identify the context (e.g., name of the in a permanently readable format.

method, the instrument hardware, or the column and solutions), the meaningfulness of the data (e.g., indica-

• Contemporaneous – are records created at

tion of a result in connection with the used unit), date

the time of the activity?

and time. Modifications are noted and documented in The

MagIC Net audit trail records all activities from all the history.

users by creating a data record with the name of the user and the client, the action, date, time, and differ-In the MagIC Net database the data is linked to the ence to UTC.

validation, calibration, and verification processes.





ALCOA+

The ALCOA guidelines were recently updated to 03

also cover aspects such as completeness, consistentency, endurance, and availability of data.

• Complete – are all relevant data stored?

• Enduring – does stored data remain avail-

MagIC Net provides in its database all the information

able for the duration of the required retention

required to create the records, including metadata and

period?

changes.

Whenever data are generated, MagIC Net makes it The audit trail provides information about all the activi-possible to save the data in the database in MagIC

ties required to obtain the data.

Net format. Subsequent versions of MagIC Net are able to read data created in earlier versions.

• Consistent – can the operation workflow be

reconstructed?

• Available – is data accessible / readable /

A formalized process systematically repeats and

printable?

re traces the data retrieval processes managed by The records are available throughout the entire re-

MagIC Net in always the same way.

tention period for checks, reviews, and audits in the database of MagIC Net and also available in other formats depending on the user’s management after a data export (e.g., PDF, CSV, SLK, CDF, or XML)

www.metrohm.com

G, CH-9100 Herisau

ohm A

witzerland by Metr

, printed in S

SW

Subject to modifications

Layout by Ecknauer+Schoch A

8.102.5006EN – 2018-08