21 CFR Part 11 EU GMP Annex 11 Conparison 1698597645
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leon tagore21 CFR Part 11 EU GMP Annex 11 Conparison 1698597645
Uploaded by
leon tagoreVS
21 CFR Part 11
vs.
EU GMP Annex 11
CAPABILITIES
21 CFR Part 11 EU GMP Annex 11
VS
Provides guidance to
Provides criteria for
the EMA GMP’s in-
electronic records,
dustry criteria for ef-
electronic signatures,
fective implementa-
and handwritten
tion, validation, use,
signatures, which are
control, and mainte-
captured for an
nance of computer-
electronic record.
ized systems.
SCOPE
21 CFR Part 11 EU GMP Annex 11
VS
Applies to all forms of
computerized systems
Applies to electronic used as part of a GMP
records, electronic regulated activities
signatures, and hand- within the EU.
written signatures ex-
ecuted to electronic Does not apply to med-
records that are cre- ical device software. It
ated, modified, main- may be applicable to
tained, archived, re- software used in the
trieved, or transmit- production of a device
ted, under FDA regula- and software used in
tions. implementation of the
device manufacturer’s
Quality system.
LEGAL
21 CFR Part 11 EU GMP Annex 11
VS
Not a legal require-
ment; it is a guideline
in the context of the
Legal requirement EMA GMPs. However, it
issued by the FDA. Ap- is mandatory on each
plicable to FDA-regu- national level in the EU
lated industries. and therefore essen-
tial for compliance
with related EU regu-
lations.
APPLICABILITY
21 CFR Part 11 EU GMP Annex 11
VS
Applies to drug, bio-
technology, and medi- Intended to ensure
cal equipment manu- product Quality, pro-
facturers in FDA-reg- cess control, or QA
ulated industries, in- when a computerized
cluding electronic system replaces
submissions to the manual operations.
FDA.
OVERARCHING STRUCTURE
21 CFR Part 11
VS
Subpart A: General Provisions
11.1 Scope
11.2 Implementation
11.3 Definitions
Subpart B - Electronic Records
11.10 Controls for closed systems
11.30 Controls for open systems
11.50 Signature manifestations
11.70 Signature/record linking
Subpart C - Electronic Signatures
11.100 General requirements
11.200 Electronic signature compo-
nents and controls
11.300 Controls for identification
codes/passwords
OVERARCHING STRUCTURE
EU GMP Annex 11
VS
Consists of four sections:
General guidance
Project phase
Operational phase
Glossary
KEY TERMINOLOGY
21 CFR Part 11 EU GMP Annex 11
VS
• Electronic signature
• Computerized
• Electronic record
system
• Electronic signature
• Accuracy checks
• Digital signature
• Audit trail
• Handwritten signature
• Data storage
• Closed system
• Printouts
• Open system
• Change Management
• Periodic evaluation
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