Overview
The Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government. It is divided into 50 titles that represent broad areas subject to federal regulation. Within each title, the regulations are broken down into chapters, parts, and then individual sections and subsections.
The Food and Drug Administration (FDA) in the United States designed Part 11 of Title 21 of the Code of Federal Regulations (21 CFR Part 11) to help ensure that life sciences companies can use electronic records and signatures that are equivalent to those based on paper and ink. It applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements in agency regulations. As spelled out by the FDA, Part 11 applies to all areas governed by the FDA.
Benefits
Compliance is just one of the benefits. Some of the other perceived – and actual – benefits experienced by life sciences companies include:
- Better quality control.
- Cost reduction associated with reduced product loss.
- Dramatically simplifies the management processes required for compliance.
- Able to search and find records in a fraction of the time.
- Minimized compliance-related headcount.
- Always prepared for FDA inspections.
- Minimized human error.
- Reductions in entry errors.
- Implements a solution quickly without disrupting the organization.
- Improved ability to analyze trends and problems.
- Improved data integrity and accountability controls.
- Increased speed of information exchange.
- Reduced cost for storage and control of records.
- Faster and more efficient FDA reviews and approvals of FDA-regulated product.
- Reductions in system vulnerability and abuse.
- Lower regulatory or compliance driven costs.
- Shorten validation time.
- Reduces the costly time delays associated with lengthy approval cycles.
- Reduction in costs related to record retention.
- And more …
The Challenge
Life science industry are under ever-increasing pressure to adhere to FDA rules for process compliancy. Without this critical certification, these companies are unable to bring products to market and are subject to financial, civil and potentially criminal sanctions.
With the increasing competition in the market for new products/drugs and the decreases in available staff, and it’s clear why these companies need to look to effective methods for ensuring compliance with government policy and procedure while decreasing time-to-market and increasing competitiveness.
The following issues may impact a company in its compliance efforts:
- Improve productivity while reducing product liability.
- Maintain superior-quality performance while conforming to regulatory requirements.
- Protect the integrity of data records.
- Understand what is required for 21 CFR Part 11.
- Spend time and money trying to comply with every process.
- Expensive consulting and customization services.
- Inconvenient Part 11 policies and procedures.
All of these are significant challenges. However, the implementation of a management system helps an organization achieve continuous performance improvement.
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