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General
Is there an inventory of all systems? X X
Are the systems uniquely identified, versioned and classified? X X X
Is there a validation of all systems? X
Personnel
Does staff have sufficient experience and training? X X X
Are there sufficient personnel available to complete the transferred tasks? X X
Do job descriptions exist? Partially X X
Do organizational charts exist? X X X
Are new systems developed with assistance from its end users? X X
Are any quality assurance aspects from the previous system lost in the new X
system?
Are users trained before using a new system? X
Are maintenance and repair personnel in the computerized systems pro- Partially Partially
duction environment trained in the relevant hygiene and zone instructions?
Are advanced training options available for computerized systems and Partially X
applications?
Are the training courses documented? X X
Life cycle
Have the systems been developed according to a life cycle? X Partially
Does a life cycle model or a project procedure model exist? X X
Is there a project plan and a corresponding SOP? X X
Is there a project concept and a corresponding SOP created? X X
Is there a quality protocol and a corresponding SOP? X
Are application specifications compiled and, if applicable, are these signed X X
by the user?
Is a risk analysis carried out and is there a corresponding SOP? X X
Is development of system components (hardware and software) docu- X
mented?
Compilation of user instructions manuals. X
Installation and start-up/SOP X X
Acceptance test planning and execution X Partially X
Release/SOP X
Change control/SOP X X X
System monitoring and maintenance/SOP X X
Error handling/SOP X X X
Planning of tests and reviews/SOP X X X
Are there plans or SOP for the retirement of systems? X X
Is the retention period of data and documentation regulated and does it X X
comply with regulatory requirements?
Retrospective validation: Does an experience report exist? X
Completeness of the documentation X X X
Risk analysis X X X
Quality protocol X X
Is authorized access regulated? X X X
Are user lists up-to-date? X X x
Are the authorizations appropriate, or are all users authorized as adminis- X X X
trators?
Is system access protected by timeout or shutting down? X X X
Are passwords protected using a suitable method and are they secure? X X X
Are entries subject to plausibility checks so that they remain within prede- X X
fined limits?
Author:
Peter Bosshard, Ph.D. GMP MANUAL
Global Quality Assurance Good Manufacturing Practice
F. Hoffmann La-Roche Ltd. & Implementation
Basel, Switzerland
E-Mail: peter.bosshard@roche.com
References:
GMP MANUAL
Good Manufacturing
Practice & Implementation
www.gmp-manual-now.com The most dependable reference tool
in the world!
PIC/S PI 011-3
Good Practices for Computerized Systems in Available as
“GxP” Environments
http://www.picscheme.org/publis/recommandatio ¬ Loose leaf book + CD ROM
ns/PI%20011- 695 € / 995 US$
3%20Recommendation%20on%20Computerise
d%20Systems.pdf ¬ Online version:
o Corporate license:
GAMP 5 For all employees of a company
Good Automated 2,100 € / 3,000 US$
Manufacturing Practice Guide,
ISPE (International Society for Life Sciences) o Named User license
http://www.ispe.org/cs/gamp_publications_sectio For one single person
n/gamp_publications_overview 595 € / 850 US$