1. Data Management for PAT, IT infrastructure, MVDA (online/offline, product lifecycle)

2. Data Collection, Processing and Use In-Process
WATER 5 4
FROM WAREHOUSE 2 1 3
150 kG/h
20n MICRON
123°C
4 HOUR SP
WASTE FS
+15°C 7
Additive 1
130 MINUTES
Additive min.
Additive min.
+5°C 9
100°C
155°C
180°C
145°C
165°C
150°C
12 min 30
3 min 15
0,6 m/min 10 11 13 12 14 S1 S2 B1 B2 F1 F2 B3
15°C - 10 MINUTES B5 P1 W1
ROLL Kg
SECONDARY
0,8x40 mm
PROCESSING S3 6
4 TRAYS :
8xx MICRON
6xx MICRON
4xx MICRON 8
2xx MICRON
61%
39%

3. Data Collection, Processing and Use In-Process
WATER 5 4
FROM WAREHOUSE 2 1 3
150 kG/h
20n MICRON
123°C
4 HOUR SP
WASTE FS
+15°C 7
Additive 1
130 MINUTES
Additive min.
Additive min.
+5°C 9
100°C
155°C
180°C
145°C
165°C
150°C
12 min 30
3 min 15
0,6 m/min 10 11 13 12 14 S1 S2 B1 B2 F1 F2 B3
15°C - 10 MINUTES B5 P1 W1
ROLL Kg
SECONDARY
0,8x40 mm
PROCESSING S3 6
4 TRAYS :
8xx MICRON
6xx MICRON
4xx MICRON 8
2xx MICRON
61%
39%
CQA1
CQA2
CQA4
CQA3
CQA4

4. Data Collection, Processing and Use In-Process
WATER 5 4
FROM WAREHOUSE 2 1 3
150 kG/h
20n MICRON
123°C
4 HOUR SP
WASTE FS
+15°C 7
Additive 1
130 MINUTES
Additive min.
Additive min.
+5°C 9
100°C
155°C
180°C
145°C
165°C
150°C
12 min 30
3 min 15
0,6 m/min 10 11 13 12 14 S1 S2 B1 B2 F1 F2 B3
15°C - 10 MINUTES B5 P1 W1
ROLL Kg
SECONDARY
0,8x40 mm
PROCESSING S3 6
4 TRAYS :
8xx MICRON
6xx MICRON
4xx MICRON 8
2xx MICRON
61%
39%
CQA5
CQA5
CQA4 (FF)
CQA1
CQA6
CQA2
CQA3
CQA4

5. Data Management – The Key Questions
How much data do we collect from the process ?
(Sampling Strategy ?, Process Speed ?, Control Requirements?, Instrument Limitations? …..)
At what speed do we process the data ?
(Real-Time?, In-Process?, Off-Line? …. What is ‘real-time’ for the process? How complex is the processing? …..)
What data do we store ?
(Raw?, Reference?, Intermediate?, CQA?, Batch?, Historical? …..)
How long do we keep the data ?
(End of Batch?, Rolling pre-defined period?, 10 years?, After product removed from market?, …..)