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Imagination at work. Customer facing Sievers M-Series TOC Analysers - DataPro 2

- DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

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Page 1: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Imagination at work.

Customer facing

Sievers M-Series TOC Analysers - DataPro 2

Page 2: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Databases

Easier to access data

More secure data

Results, etc. are saved in the right place

Not easy to delete files on M9 as it was with DataPro

900

Network administrator can have good control on who

can access the data e.g. user cannot accidentally delete

data

Microsoft SQL is a type of database

Page 3: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Database structure

DataPro 2 is a database engine: it queries the data

Good for 21 CFR Part 11 and EU Annex 11 compliance

Data of record should be documented as that on the PC

Both instrument and DataPro 2 have Part 11 compliance

Instrument and DataPro 2 communicate continuously so the data on the

instrument is simply like a backup

3

Client tier

Database engine (e.g. DataPro 2)

Database files (e.g. results)

Page 4: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

4

On SRC located in the “Instrument Software Installation Files\DataPro DVD” folder

Page 5: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

SQL Database Structure

5

Graphic courtesy of Microsoft Corp., MSDN Website 2014.

Page 6: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Home Screen Overview

6

Same menu icons as on the

instrument

Page 7: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Home Screen Overview

7

Up to 4 instruments can

be connected

Page 8: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Home Screen Overview

8

Protocol and Vial information

Page 9: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Home Screen Overview

9

Autosampler rack

display

Page 10: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Home Screen Overview

10

Results populate in real-time

Page 11: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Home Screen Overview

11

Method for the selected vial shown here

Page 12: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Home Screen Overview

12

Consumables status

Page 13: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Home Screen Overview

13

Errors and Warnings

Page 14: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Setting Up Methods & Protocols

14

We’re in the Setup tab

Page 15: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Creating and Saving Methods

Methods define how a vial will

be measured

• Values and options can be set

per customers’ needs

• Methods can be saved, if desired

Methods must be applied to

one or more vials

15

Page 16: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Creating Protocols

16

One or more vials must be

“placed into” the rack by

highlighting them

• Some Excel® rules apply

– shift, ctrl, dragging

Page 17: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Creating Protocols

17

One or more vials must be

“placed into” the rack by

highlighting them

• Some Excel® rules apply

– shift, ctrl, dragging

Apply the method to the

selected vials

Page 18: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Creating Protocols

18

One or more vials must be

“placed into” the rack by

highlighting them

• Some Excel® rules apply

– shift, ctrl, dragging

Apply the method to the

selected vials

Vials will appear as grey,

stylized vials

Page 19: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Creating Protocols

19

One or more vials must be

“placed into” the rack by

highlighting them

• Some Excel® rules apply

– shift, ctrl, dragging

Apply the method to the

selected vials

Vials will appear as grey,

stylized vials

The table below is editable

Page 20: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Managing Favorites: User Protocols and Methods • Protocols and methods can be organized and ranked on Favorites

page.

• All Protocols/Methods will appear under favorites unless removed.

• Favorites can be organized into any order.

• Non favorites (Available) appear in the order they are removed from

favorites.

20

Page 21: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

Stacking Protocols

21

• Automated series of

protocols

• Allows stacking user-

protocols:

Suit – Samples - Suit

Page 22: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

DataGuard: Access Levels

22

- User can create a new Access level

by

clicking Add, typing in a level name

and

moving the desired roles to the

selected field.

- Highlighting an existing Access level

and selecting Edit a user can add or

delete roles to a an access levels.

- Highlighting an existing Access level

and selecting delete an access level

can be removed if it is not associated

with a User ID.

Page 23: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as

DataGuard: Settings

The settings tab allows the user to modify the default

settings to meet required standards.

23

Page 24: - DataPro 2€¦ · Database structure DataPro 2 is a database engine: it queries the data Good for 21 CFR Part 11 and EU Annex 11 compliance Data of record should be documented as