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TECHNOLOGY UNIT MEDTECH / PHARMA / LIFESCIENCE

MEDTECH / PHARMA / LIFESCIENCE · Consistent Good Engineering Practice (GEP) for order pro-cessing V-Model as basis Validation and qualification (DQ, IQ, OQ, PQ, FAT & SAT) based

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Page 1: MEDTECH / PHARMA / LIFESCIENCE · Consistent Good Engineering Practice (GEP) for order pro-cessing V-Model as basis Validation and qualification (DQ, IQ, OQ, PQ, FAT & SAT) based

TECHNOLOGY UNIT

MEDTECH / PHARMA / LIFESCIENCE

Page 2: MEDTECH / PHARMA / LIFESCIENCE · Consistent Good Engineering Practice (GEP) for order pro-cessing V-Model as basis Validation and qualification (DQ, IQ, OQ, PQ, FAT & SAT) based

Due to the change in age structure as well as in the people’s awareness paying more attention to their health, medical technology is beco-ming evermore important as a link between the technical and medical sector.

Strama-MPS responds to this need within the Technology Unit and offers versatile solutions with its services.

Medicine should not only give years to the life,

but also life to the years.Georg Christoph Lichtenberg

Competencies

Consistent Good Engineering Practice (GEP) for order pro-

cessing

V-Model as basis

Validation and qualification (DQ, IQ, OQ, PQ, FAT & SAT)

based on a validation master plan

Implementation of valid standards (e.g. EU-GMP guide,

GAMP 5, FDA 21 CFR part 11)

Active change management

Complete traceability matrix for logical traceability

GMP-compliant documentation

You benefit from our intensive focusing on special expertise in

FMEA

Risk analysis

Quality assurance

Data analysis

Plant simulation

Line Data Server with MES Integration

Services

We develop and manufacture automated assembly and

testing systems for the production of medium to large

quantities in clean rooms

Production of individual parts up to small and medium

batch sizes on our extensive machine park

Assembly and commissioning of mechatronic assemblies

and components

Page 3: MEDTECH / PHARMA / LIFESCIENCE · Consistent Good Engineering Practice (GEP) for order pro-cessing V-Model as basis Validation and qualification (DQ, IQ, OQ, PQ, FAT & SAT) based

MOVING THE LIMITS.TOGETHER. CONSTANTLY.

Strama-MPS

Maschinenbau GmbH & Co. KG

Ittlinger Straße 195

94315 Straubing / Germany

P +49 9421 739-0

Fax +49 9421 739-247

www.strama-mps.de

Martin Ebner

CTO, Technology Unit

P +49 9421 739-441

[email protected]

Fabian Hornburger

Quality Engineer

P +49 9421 739-522

[email protected]