Pharma Package QP1

The Pharma software application package contains applications concerning the topic compliance with pharmaceutical-relevant guidelines as 21 CFR Part 11 and USP 39, Chapter 41. The Pharma package includes applications such as user management, digital signatures, audit trail, USP minimum weight.

QApps included in the Pharma Package (QP1):

User Management

The function extension user management enables user accounts and access management to be set up as per guidelines in Directive 21CFR Part 11.

Virtually any number of user accounts can be configured and are assigned freely definable roles with specific access rights.

A user account can be used either without a password, with a local password, or with a network password (single sign-on with LDAP). All settings, as well as login and log-out actions, are logged in the audit trail.

User accounts, roles and access management are configured in the Settings menu. Rules for logging in, logging out and the local password assignment can be fully configured in line with Directive 21CFR Part 11.

Material No. QAPP100

Available languages: English, German, Chinese, French, Italian, Japanese, Korean, Russian, Spanish and Portuguese

Last update: 15/05/2019

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Electronic Signature

The function extension electronic signature enables an electronic report or printout to be signed using electronic signatures.

The electronic signature process complies with Directive 21CFR Part 11 and is conducted in the workflow by entering the user password immediately before creating a report. All signature actions and results are logged in the audit trail, as well as on the electronic report or printout.

In order to use electronic signatures, separate user accounts and passwords are mandatory as per 21CFR Part 11. It is not possible to use accounts without a password.

The electronic signatures can be activated/deactivated in the Settings menu under Device settings. This setting affects all tasks. 

The permitted user accounts and password must also be set up in User management.

Material No. QAPP101

Available languages: English, German, Chinese, French, Italian, Japanese, Korean, Russian, Spanish and Portuguese

Last update: 15/05/2019

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Audit Trail

The function extension audit trail enables the activities on the device to be logged in an audit trail as per guidelines in Directive 21CFR Part 11. The audit trail charts all relevant results and modifications on the device, for example: 

  • Creation/modification/deletion of tasks, users or roles - Login, logout, electronic signature
  • Modifications to clock, apps, settings menu 
  • Leveling, calibration and adjustment
  • and much more.

The audit trail can be viewed in the Settings menu under Device information and can be filtered and sorted by several criteria. These functions are also available on the network via the website for the balance. It is possible to export as a PDF.

The audit trail is a ring buffer with 150,000 entries and cannot be manipulated.

Material No. QAPP102

Available languages: English, German, Chinese, French, Italian, Japanese, Korean, Russian, Spanish and Portuguese

Last update: 15/05/2019

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minUSP

The function extension minUSP monitors compliance of the permitted working range as per US Pharmacopeia (USP) Section 41 and alerts the user when weighing values fall below the working range.

The minUSP function can be activated/deactivated in the Settings menu under Device Settings. The starting point of the working range must be entered as the parameter in line with US Pharmacopeia (USP) Section 41. To calculate the valid starting point, you can either use QApp USPAdvanced or contact Sartorius Service. The minUSP function is also able to mark measuring values outside the working range as invalid, thus preventing impermissible values from being transferred. 

The minUSP function can also be used to monitor working ranges in line with other regulations by calculating and entering the starting point accordingly.

Material No. QAPP103

Available languages: English, German, Chinese, French, Italian, Japanese, Korean, Russian, Spanish and Portuguese

Last update: 15/05/2019

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USP Advanced

The USP Advanced application determines the value for the starting point of the permitted working range according to US Pharmacopeia (USP), Chapter 41. The procedure starts with the repeatability test where 10 weight values of the same weight are measured and the balance is zeroed/tared automatically between the measurements. The second test segment is the accuracy test, which uses an OIML or ASTM weight or a calibrated weight to acquire one weight value. The USP Advanced application calculates the standard deviation, minimum operating range (ORmin), maximum operating range (ORmax) and determines if the result of the repeatability and accuracy test meets the requirements of USP Chapter 41. The application uses the following calculations and formulas:

  • Standard deviation:
  • sum = comp1 + comp2 + ... + comp10
  • mean = sum/10
  • standard deviation = SQRT ((comp1 - mean) ^ 2 + (comp2- mean) ^ 2 + ... (comp10 - mean) ^ 2) / 9 )
  • Operating range min (ORmin)
  • if standard deviation <= 0.41 digit, set standard deviation to 0.41.
  • if standard deviation > 0.41 digit, set ORmin = 2* Standard deviation * 1000;"
  • Operating range max (ORMax)
  • ORMax = balance capacity (WEIGH/METR_MAX)

Repeatability test is OK, if:

  • Smallest desired net weight (Ms) is between the operating range and
  • (2*s/Ms) <= 0.001 // Ms = smallest desired net weight. s = standard deviation: If standard deviation <= 0.41, set standard deviation to 0.41.
  • Accuracy result is OK, if abs(nominal value + deviation - measured value) <= (0.001*(nominal value + deviation))
  • Maximum permissible errors or tolerance limits as +/- mg for weights are used according to OIML R111-2004 and ANSI/ASTM E617

Material No. QAPP104

Available languages: English, German, Chinese, French, Italian, Japanese, Korean, Russian, Spanish and Portuguese

Last update: 15/05/2019

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User Calibration

The application user calibration features a guided external calibration process with up to 5 different OIML or ASTM weights. The user is guided through the complete calibration process and gets a comprehensive report if the calibration is passed or failed. Additionally the application for each calibration weight offers a long time evaluation of results based on the user defined warning and action limit. If the warning limit is reached or exceeded the user gets a warning message, if the action limit is reached or exceeded weight values become invalid and the user calibration procedure must be repeated.

Material No. QAPP106

Available languages: English, German, Chinese, French, Italian, Japanese, Korean, Russian, Spanish and Portuguese

Last update: 15/05/2019

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