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If it hasn't been documented, it hasn't been done
The pharmaceuticals industry is confronted in equal measure by strict regulations and by risks in the preliminary stages of investments, and these risks have to be identified and eliminated.
To provide a sound basis for automated systems projects, the GAMP (Good Automated Manufacturing Practice) guidelines are used by both the pharmaceuticals industry and the suppliers. GAMP lays down the main phases of a project, i.e. specifications, design, implementation, testing and risk analysis.
- Bild: GAMP V-Modell
Using international regulations such as GAMP or FDA (US Food and Drug Administration) cfr21 part 11, Sauter's project teams develop and implement building automation systems for international clients the world over.
By joining the projects as early as the specification phase, Sauter's project teams ensure that completion occurs on time and within budget.
Because of its many years of practical experience and its flexible systems, Sauter is the ideal – and highly competent – partner for projects in the life sciences sector.
References
- Inpharzam, Switzerland
- Sandoz Pharma Gerlingen, Germany
- Chiesi Farmaceutici Spa, Italy
- Hermofarm, Serbia
- Roche Shanghai, China
- Janssen Cilag, India