The US Food and Drug Administration (FDA) has established Part 11 of Title 21 of the Code of Federal Regulations (FDA 21 CFR Part 11), which contains safety requirements for life science companies. These requirements ensure that electronic records and signatures are legitimate and authentic, allowing them to replace their paper counterparts in many situations. Many companies also apply FDA 21 CFR Part 11 to improve the security and reliability of IT systems.
Demand for drugs has been increasing significantly, while
regulatory agencies tighten the approval process for new drugs. Strong
regulation poses many challenges to the industry, requiring companies to direct
their efforts to ensure that stringent quality and compliance standards are
met. In this way, they prevent products from presenting quality and safety
problems, which can result in fines or legal penalties and weaken the company's
image, directly impacting revenue and market share. https://www.eleapsoftware.com/21-cfr-part-11/
The solution to FDA 21 CFR Part 11
SoftExpert offers the most comprehensive and advanced
software solution for compliance management that meets the requirements of the
most diverse global regulatory standards. The SoftExpert Excellence Suite helps companies in compliance with FDA 21 CFR
Part 11 requirements, while increasing security and reducing the risks and operating
costs.
The SoftExpert solution allows organizations to easily meet
the requirements of FDA 21 CFR Part 11, through resources for managing
documents, records, reviews, access control, audit trail, in addition to
non-conformities, indicators, processes, among others , increasing
organizational efficiency and avoiding rework and waste.
With online collaboration capabilities, the organization and
its managers have greater visibility and can stay up-to-date on regulatory
compliance initiatives. The solution integrates users, teams and departments
through standardized processes, simplifying the entire process of preparing for
FDA audits.
Main benefits of the solution
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Reduces efforts to comply
with FDA, ISO and other regulations.
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Simplifies the preparation,
review and approval of regulatory documents.
Ø
Prevents the existence and
use of duplicate and obsolete documents.
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It only guarantees access
to current documents and avoids process deviations.
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Ensures availability and
traceability of information for FDA audits.
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Promotes the company's
commitment to quality and customer safety.
Ø
Provides customers with a
better experience with products and services.
Implications Of 21
CFR Part 11 For The Industry
By introducing the 21 CFR Part 11 regulation, the FDA have
basically enabled the Life Science community and other FDA regulated industries
to streamline business procedures, automate constructing supply bonds, reduce
turnaround time and costs, reducing risk of human errors all by establishing
standard criteria for the use of electronic records and signatures.
However, to utilize these noteworthy benefits, FDA modulated
companies must maintain requisite features in their organizations, establish
Standard procedure, and perform regular Method Validation.
What is FDA
Regulation 21 CFR Part 11 ?
FDA Regulation Title 21 CFR Part 11( also known as 21 CFR 11
), Electronic Records/ Electronic Signatures, is the part of the Code of
Federal Regulations that establishes the United Nation Food and Drug Administration(
FDA) regulations on electronic records and electronic signatures. Exclusively,
21 CFR 11 defines the requirements for submitting documentation in electronic
form and the criteria used for approved electronic signatures.
Who needs to comply
with FDA Regulation 21 CFR Part 11 ?
All FD-Regulated industries, which includes pharmaceutical,
production processes medical inventions, nutrient& refreshment
manufacturers and cosmetics companies, must conform to 21 CFR 11. Computer
organizations( including analytical instruments with onboard computers) which
store or produce data to stir excellence verify decisions, or reporting data
for the FDA must comply with 21 CFR 11. This includes any laboratory answers
used to determine quality, refuge, forte, efficacy, or integrity. In
manufacturing environments, this includes data used to make decisions related
to product release and product quality.
