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"Good documentation is
an essential part of quality assurance. Clear and understandably
written documents let us avoid the mistakes that arise
in verbal communication and make it possible to trace
the history of a production lot." (excerpt from
EU GMP guidelines)
Our Offer
Consulting, staffing support and execution of
- Documentation structure
- Standard Operating Procedures
- Production documentation
- Technical documentation
- Document Review
Our Procedure
We advise and support during the implementation of documentation
systems using basic concepts adapted to your individual
needs that also comply with GMP and other regulations
(e.g. quality management, personnel and environmental
safety laws). Our goal is always an integrated, uniform
and comprehensive system.
Our competent, specialist personnel create,
independently or according to your guidelines, various
documents and check them for completeness, actuality
and content conformity, especially as regards potential
inspections. Sophisticated checklists ensure that no
important documents are missing.
Event schedules, activity lists and defined
procedures ensure the ongoing maintenance, actuality
and completeness of these documents as required by GMP.
Your Result
A uniform and clearly structured documentation system
that contains all of the important documents required
to run plant in accordance with GMP. |
Consulting
