Professional Documents
Culture Documents
Disclaimer
http://www.ispe.org/gamp5
Context Trend of EDMS over the last 15-20 YearsMatching the Evolution of GAMP
1994
2002
2010
Validation approaches have had to adapt
to this change as more of the activities
do you need to
VALIDATION OF AN EDMS
ON-PREMISE VS CLOUD
(outsourcing)
Se r v i ce
Co m p o n e n t s
GA M P
Ca t e g o r y
W h at t o do?
W ho?
I aaS
Hardware, I nt ernet
Connect ivity, Power,
Server s, St orage and
RAM, VMWare, Hyper-V
PaaS
O/ S, Windows Server,
SharePoint and SQL
Qualify t he st ack.
Manage / cont rol
ongoing changes.
Audit procedures.
Validat e t he
host ed applicat ion.
URS and UAT
AV
SaaS
AV or Sponsor
Sponsor
management
How could this breakdown into activities for a multisupplier Cloud delivery?
Activities:
IaaS
Provider
Note: Can use separate matrices for Project activities and Ongoing Service
consistent terms are that apply to your company by Quality AND IT staff
Lack of understanding of the enabling technologies, how they work and
interactions between them and other applications
Suppliers
Without understanding what the regulated company needs and where the risk is
Without defining responsibilities
Without appreciating and the cost of compliance the Life Science company
requires
*this is not unique to Cloud suppliers, this is general outsourcing and Supplier management
misunderstanding, usually after the contracts have been signed by procurement and variations
occur
Example 1
Example 2
SUMMARY
REFERENCE MATERIAL
Useful References
GAMP 5: http://www.ispe.org/gamp-5
NIST: http://www.nist.gov/itl/cloud/index.cfm
ICH: http://www.ich.org/
Annex 11:http://ec.europa.eu/health/files/eudralex/vol-4/annex11_012011_en.pdf
21CFR Part11:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm
GAMP Community of Practice: http://www.ispe.org/gampcop