When choosing a software solution which will contain regulated records, make certain that it meets 21 CFR Part 11 requirements. Many software development vendors within the life sciences space have functionality specifically for compliance with Part 11 requirements. USDM has worked with many of those vendors (e.g., DocuSign, Adobe Sign, and others), so you'll make certain your eSignature capabilities are supported business process best practices.
USDM brings together a community of vendors that meet the
standard and compliance demands of regulated businesses. we've solutions for
eSignature, content management, quality management, clinical systems, supply
chain, and distribution to determine the inspiration for your IT compliance.
USDM's Cloud Assurance™ ensures that each one of our partner solutions include
end-to-end GxP compliance—from implementation through ongoing validation
maintenance, including new software releases—for your cloud applications. USDM
helps you decide on the proper vendor for your needs, with solutions for 21 CFRPart 11 compliance and other regulatory requirements.
In light of the worldwide pandemic and therefore the got to
maintain business continuity, there has never been a far better time for
DocuSign's cloud-based agreement solution for your compliant eSignature needs.
DocuSign and USDM Life Sciences can assist you reinvent your business processes
while providing implementation and validation services that permit you deploy
with ease and expertise.
How 21 CFR Part 11 Affects Cloud Data
One reason numerous companies are moving their data to the cloud is for the IT cost savings. for all times sciences companies, moving their data to the cloud and maintaining compliance with government regulations may be a major concern. Regulatory compliance must be a part of their cloud solution and, while many cloud computing providers make sure the authenticity, integrity, and confidentiality of electronic records, cloud providers aren't regulated
.
USDM focuses on providing answers and solutions for
regulated companies looking to maneuver their software and servers to the
cloud, and lots of of the most important software and hardware companies within
the world come to USDM for best practices within the cloud. As a recognized
global leader in life sciences compliance, USDM cloud solutions provide
enterprise-grade security, cost less, and ensure compliance.
Contact USDM. We understand the importance of business
continuity and compliance, we meet all of your global regulatory requirements,
and that we are committed to delivering your Part 11 compliant solution quickly
and properly .
USDM delivered DocuSign, fully validated and compliant, to
enable eSignature functionality for workers working remotely thanks to COVID-19
The customer, Autolus, was ready to be up and running in
only seven days and maintain business continuity. Further, the entire
validation documentation and maintenance of software changes through a Cloud
Assurance subscription set Autolus up for future growth and scalability to
expand into new use cases while staying during a continuously compliant state.
Transitioning a whole life sciences organization to be ready
to support performing from home during the COVID-19 pandemic are often
daunting. USDM can help.
The Situation
Autolus, a biopharma company at the forefront of cancer
treatments
The company needed a quick solution for eSignature
capabilities thanks to the COVID-19 remote working mandate
Stakeholders included IT, QA, and therefore the business
system owner
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