Newsletter LOGFILE N° 3 - May 2009 Maas & Peither AG, www.gmp-publishing.

com

Computer Validation: ment activities in accordance with the V

model.
Questionnaire for Auditing
of IT Service Providers ¬ Review quality assurance systems

Another important issue to consider is the sup-

plier’s error investigation and resolution
process. Companies should analyze reported
errors from existing system users and the sup-
plier should inform customers when a global
error has been detected.

Written by The focus of a service provider audit is to ana-

Peter Bosshard, Ph.D., lyze change management procedures, report-
F. Hoffmann La-Roche ing, and documentation and to ensure that the
Ltd, Basel, Switzerland service provider is performing all tasks in ac-
cordance with the service level agreement.
Conducting regular service provider audits de-
When starting a business relationship with an monstrates a company’s preparedness to un-
IT service provider the following steps should dergo an audit by the authorities if the need
be taken: should arise.
The following question catalog offers a practic-
¬ Conduct a formal supplier assessment. al and helpful supplement to the question cata-
log in the PIC/S guidance (PIC/S Guidance
¬ Conduct a supplier audit to ensure the Good Practices for Computerized Systems in
supplier correctly performs all develop- Regulated “GXP” Environments)

Question Supplier Service Intern

Provider

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

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Newsletter LOGFILE N° 3 - May 2009 Maas & Peither AG, www.gmp-publishing.com

Question Supplier Service Intern

Provider

Service level agreements

Do service level agreements exist? X Partially
Do these contracts include quality assurance measures? X Partially
Do contracts restrict the transfer of tasks or data to third parties? X X
Do the contracts permit audits and inspections? X 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?

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Newsletter LOGFILE N° 3 - May 2009 Maas & Peither AG, www.gmp-publishing.com

Question Supplier Service Intern

Provider
Is critical data reviewed? X X
Is a data archiving process performed using a long-text format (PDF, TXT)? X X X
Is later retrieval of data guaranteed?

Is data archived on long-term media? (Magnetic media should be rewritten X X

every two to three years, since magnetic information becomes lost over
time)
Are full backups performed on a regular basis? Partially X
Are two generations of full backups available? Partially X
Have the backups been checked for completeness and recovery ability? Partially X
Are daily incremental backups performed? Partially X
Are alternative systems available in the event of a failure? Partially X
Are procedures for restarting a failed system clearly defined and approved? X X

(Article based on GMP MANUAL, chapter 9 Computer validation; www.gmp-manual.com )

Author:
Peter Bosshard, Ph.D. GMP MANUAL
Global Quality Assurance Good Manufacturing Practice
F. Hoffmann La-Roche Ltd. & Implementation
Basel, Switzerland
E-Mail: [email protected]

References:
GMP MANUAL
Good Manufacturing
Practice & Implementation
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