Peace-of-mind with

OMNIS Compliance package 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 OMNIS software gives you peace of mind, as it ensures all data to have the following qualities stipu-la ted by ALCOA and ALCOA+.

OMNIS compliance licence (6.0600.4010) provides all necessary features for achieving data initegrity and compliance to FDA 21 CFR part 11 and EudraLex, Vol.4, Annex 11.





02

ALCOA

• Attributable – who performed which action

• Original – is this the fi rst recorded observation

and when?

or a verifi ed, true copy?

OMNIS stores in the database and in the audit trail the OMNIS identifi es the original data based on the ver-name of the person performing the task, together with sion number of the original record. It is possible to the date and time of each action. (Data creation, data trace back to the original version and exctract original modifi cation, login/logout attempts, data retrieval, ...) parameter settings of the processes at the time of the data creation.

• Legible – does data remain readable through-

out the complete lifecycle?

• Accurate – is data stored correctly and are

Whenever data are generated, OMNIS makes it pos-

modifi cations clearly documented?

sible to:

OMNIS provides the necessary metadata for all data

• save the data in the OMNIS database. Subsequent in order to identify the context (e.g., name of the me -

versions of OMNIS are able to read data created in thod, the hardware, or the sensors and solutions), the earlier

versions.

meaningfulness of the data (e.g., indication of a result

• export the data to the network or an external in connection with the used unit), date and time. Mod-me

mory as a full set of dedicated PDF reports or ifi cations are noted and documented in the audit trail.

in the OMNIS fi le format. In this case, the user is responsible for archiving the data in a permanently In

the

OMNIS database the data is linked to the cali-readable

format.

bration, processes and complete instrumentation used during a determination.

• Contemporaneous – are records created at the

time of the activity?

The

OMNIS audit trail records all data generating activities from all users by creating a data record with the name of the user and the client, the action, date, and time.



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 readable

OMNIS provides in its database all information requi-

over the complete lifecycle?

red to create data records, including metadata and Whenever data are generated, OMNIS makes it pos-changes.

sible to:

• save the data in the OMNIS database.

The audit trail provides information about all the activi-

• export the data to the network or an external ties required to obtain the data.

memory as a full set of dedicated PDF reports or in

the

OMNIS fi le format. The user is responsible

• Consistent – can the operation workfl ow be

for archiving external data for the duration of the

reconstructed?

required retention period.

A formalized process systematically repeats and retrac-es the data retrieval processes managed by OMNIS in • Available – is data accessible / readable /

always the same way. The original process of a deter-

printable?

mination is always available to restore and export for The data records are available throughout the entire further use.

retention period for checks, reviews, and audits in the OMNIS database and are also available in other stan-dard formats depending on the user’s management after a data export (e.g., PDF). The audit trail can be ex ported as CSV for further review or archiving.

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