| |
Click on the following
links for detailed information on selected projects:
Computer System Validation (CSV) for pharmaceutical production process
GxP-conforming quality management system for major hospital pharmacy
21 CFP Part 11 Compliance Pharma laboratory systems for production and
analysis
21 CFP Part 11 Compliance consolidation
SIP – Strategic Information Planning and Personnel Management
Click here for a detailed summary of our projects.
|
|
| |
Computer System Validation (CSV) for
pharmaceutical production |
| Goal |
 |
|
Retrospective validation of all production
related computer systems for a pharmaceutical production process (PPS,
administration of dispensing and invoicing, logistics systems, automation,
building technology). Parallel implementation of a new quality management
system to continuously upgrade software for the protection of the
validated status. |
| Method |
|
|
Audit of the validated status and quality
management processes, record of all computer systems involved, analysis
of all processes and systems, implementation of cGMP-assessment, complete
V-Model documentation, design and implementation of all validation
tests, management of all validation activities during normal course
of business, SOP analysis, training and implementation, management
of fault repair activities. |
| Result |
|
|
Validation of all computer systems and
implementation of electronic quality management systems. |
| Duration |
|
|
1½ years |
|
