HOSOKAWA ALPINE – Alpine Air Jet Sieve

ALPINE LS-PRO Software OPTION: 21 CFR Part 11

Screenshot LS PRO Zoom

System requirements

	PC with Pentium®-class processor or higher
	Microsoft® Windows®98, Windows NT 4.0 with Service Pack 6, Windows 2000 or Windows XP
	16 MB RAM (32 MB recommended)
	10 MB unoccupied hard disk memory
	CD-ROM disk drive
	VGA graphics card, 1024 x 786 pixels
	2 free serial interfaces with no interrupt conflicts
	PS-2 mouse

Brief description
Interactive control of the complete air jet sieving process with indication of the respective status. The sieving documentation includes date, time, user, sample identification, sieving parameters, peripheral conditions, error messages and other comments.

The particle size distributions can be displayed and stored in table-form or as a graph. The analysis results can be represented in the form of a table or graph (with curve compensation, extrapolation, and approximation) in different grids, i.e. semi-logarithmic and RRSB grain size grid. Trend representation of selected analyses using x50, for example. (Up to 10 different analyses can be displayed simultaneously.) Standard sieve sets can be stored in memory to facilitate uniform analysis procedures. Data transfer via clipboard to other Windows® programs. On-line help functions available.

Screenshot LS PRO Admin-Tool Zoom

OPTION:
SOFTWARE LS PRO 5.0 as defined in 21 CFR Part 11

HOSOKAWA ALPINE interprets 21 CFR Part 11 as follows:

ER - Electronic Recording:

	The recording of data in digital form.
	The stored data must be retrievable and legible at all times for FDA inspection.
	The recorded data must be stored such that they cannot be manipulated.
	The recorded data must be stored in a permanent manner for at least 10 years.

ES - Electronic Signature:

	Unmistakable identification of the user. System access is user-specific for individual functions. Electronic signature.
	Log-in by means of user identification and password.

IMPORTANT: FDA mandates that a password has a maximum validity of 90 days, that every password can only be used once.

The ALPINE Air Jet Sieve meets the requirements laid down in 21 CRF Part 11, provided that the system includes the following components or functions:

1. Operation with the LS-PRO 5.0 (or higher) software package
2. Underpressure regulation
3. Automatic sieve recognition
4. Vacuum cleaner
5. Laboratory balance
6. Validation documentation for the complete Alpine Air Jet Sieve 200 LS-N system to customer specifications.

Hosokawa Alpine fulfils the functions "Electronic Recording" and "Electronic Signature" as follows:

1. Log-in only possible by means of user identification and password
2. Integrated password management and authorisation structure
3. Manipulation-proof storage of analysis data
4. Possibility of transferring stored analysis data to another network or of saving the data to CD.

Regular data back-up performed by a special operating procedure (SOP). The FDA directive does not specify in this respect exactly which procedure best meets the requirements.

ATTENTION: HOSOKAWA ALPINE will disclose neither the actual program or program structure of the ALPINE Air Jet Sieve 200 LS-N nor that of the LS-PRO software package. In the application here, the software can be considered as standard software because it is used in numerous industrial applications. Customisations are not carried out. The actual functions of the software are qualified and documented by means of tests.