21 CFR Part 11
Overview
Current Challenge
21 CFR Part 11 is not specific to any type of instrument or technology, but applies to all instruments, applications, and operations that save data electronically to durable media. Assessing a plan on an instrument-by-instrument, or application-by-application basis is not an effective way to plan a compliance strategy. Bringing existing systems - whose original designs may not have included capabilities relating to authentic electronic records - into compliance can be a complex and cumbersome task. Achieving authenticity, reliability, and long-term availability of electronic records is especially taxing on an enterprise-wide basis because record content and structure can easily be altered by the systems used to create and interpret them.
NuGenesis SDMS Solution
The Web-based application-independent NuGenesis SDMS platform integrates with multiple analytical and software systems for a compliant, enterprise-wide data management solution. NuGenesis SDMS
also brings existing systems into compliance.
All technical requirements of 21 CFR Part 11 can be
met with NuGenesis SDMS, which includes audit
trails, traceability, electronic signatures,
and a security grid for access control.
NuGenesis SDMS also provides direct access to archived data so that it can be
easily located and quickly restored to
satisfy internal inquiries or FDA
inspections.
NuGenesis SDMS User Comments
DMPK
"Reduced the time required to assemble compound reports and to comply with part 11."
Analytical R&D
"We wanted to be compliant with new rules like Bioanalytical Method Validation, and 21 CFR Part 11. As a CRO lab working in compliance with these industry regulations, we are
now more competitive than other companies."
Chemistry/BioChemistry
"Eliminated lost or missing data.
Our data was printed to paper and
stored in packets and binders,
then microfiched in the document
center. NuGenesis SDMS
traceability function links back
to the original data
electronically, meeting regulatory
requirements."
Parallel Chemistry
"Controlled, automated capture of lab data
for 21 CFR Part 11 compliance and to
eliminate loss due to human participation in
the backup process and thereby protect IP
position."
Quality Opps/Stability
"With all Waters LC and GC data captured in NuGenesis SDMS, we do not have to rely on IT to protect raw data
and comply with 21 CFR Part 11
regulations."
Quality Control
"Downstream Turbochrom data for 21 CFR
Part 11 compliance."
Pharma Drug Safety
"We were working with huge TOF files, and saved time by eliminating tedious file backups
while complying with 21 CFR Part
11. Data is requested frequently and can be found instantly - versus over the course of a week as it was originally."
21 CFR Part 11
Resources
www.21CFRPart11.com is a Web site developed and supported by NuGenesis Technologies
that provides information on the rule and
hosts an email newsgroup forum for active discussion
of issues and concerns with industry peers and government regulators. The community is encouraged to contribute articles, papers and presentations regarding 21 CFR Part 11 and its impact on the GxP environment
Published Material
nugenesis.com articles page
21CFRPart11.com library page
White Paper: NuGenesis SDMS in 21 CFR Part 11 Compliance
Educational Opportunities
NuGenesis Technologies has considerable expertise in regulatory matters and conducts regular hotel and
online seminars on 21 CFR Part 11 and scientific data management, usually without charge to participants.
See the
www.21CFRPart11.com or
www.nugenesis.com Web sites to check
availability..
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