IT Compliance und GxP-Services
(IT Compliance by GLP, GMP, GCP, GAMP5)
The development and maintenance of standardized quality management systems, planing, implementation and operation of valid IT systems landscapes or support for regulatory inspections considerable demands on the technical know-how and the disciplined application of relevant laws and regulations.
Good to know:
In mayor organizations, IS+S is involved of the GxP environment and observing the current trends in the qualification profiles of international authorities. Working methods and trainings are continually adapted on the current circumstances.
In mayor organizations, IS+S is involved of the GxP environment and observing the current trends in the qualification profiles of international authorities. Working methods and trainings are continually adapted on the current circumstances.
Quality management
Use the experience of IS+S for an economic implementation and to maintain the audit proofed, process orientated quality systems.
- Standardized guidelines for a GxP-compliant validation
- Implementation of GAMP5 recommendations to increase the profitability
- Education and training GxP and GAMP5
- Standardized SOPs for the implementation and operation of IT systems
- Professional inspection support (Authority, supplier audit)
Computer validation
The acceptance of regulated IT projects is influenced by the efficiency of the validation. Compliance and efficiency is made possible by extensive IT expertise and efficient implementation of GxP.- Planning and support the validation of IT systems (Computerized Systems)
- Qualification of IT infrastructure (systems, data centers, networks)
- External validation manager
- Risk analysis and desaster recovery scenarios
- operating GxP-compliant systems
Electronic archives
Electronic archiving is the current "scandal" in the IT and GxP scene. Unique regulary requirements are defined and will manifest the challenge of data owners and IS functions.- Implementation of audit proof processes for an electronic archiving. (data owners - IS functions)
- Stringent implementation of the GLP consensus document Nr. 15 "Machbarkeitsstudien und Strategien für Systemarchive"
- Implementation of system archives
Audit Service GLP/GMP
All are equal before the law. Pharmaceutical companies und IT service providers appreciate our professional preparation and implementation of internal and external audits.- Implementation of supplier audits on behalf of GxP Referate
- Preparations and monitoring of inspections in audited companies
- Professional training and coaching of employee
- Providing external inspection manager