Brochure

Advantage Service Program for the pharmaceutical industry
Step 1:
Service
Step 2:
Technical solution
Step 3:
Validation
Step 4:
Service
8
Service – maintaining your validated
status over the long term
Initial validation is the first challenge, but maintaining your validated status during
system operation is just as important and challenging.
Maintaining your validated status
We offer a unique service program in-
cluding re-calibration of sensors, tests
according to 21 CFR Part 11 and integrity
tests that help you maintain your vali-
dated status over the long term.
Business process continuity
Regulatory authorities require evidence
that upper limits are not exceeded in the
event of failures or breakdowns which
would jeopardize product safety and
critical data. With our business continuity
services we make sure that your data
is protected and that you can offer a
continuous supply of your products to
the market.
Services in detail
– Backup integrity
We check that backups are readable.
– Archive tests
We check the integrity of all archived
data and check your data retrieval
procedures.
– System integrity
Your system’s performance, integrity
and availability are essential for your
success. We provide CMT maintenance
so you can meet these requirements.
– Calibration
All regulated facilities are required to
re-calibrate all critical process equip-
ment routinely. Our calibration service
ensures that the sensors used for critical
measurements are always within the
required tolerances.
Highlights
Validated status is ensured over
the long term thanks to a compre-
hensive service program
Proof of backup ensures a
continuous supply of products on
the market