Enterprise Solutions
21CFR11 Compliance
21CFR11 Compliance: The Challenge
Large and growing enterprises are facing a challenge to their core missions of developing and producing new products including food, therapeutic pharmaceuticals, medical devices, cosmetics or other public health enhancing items. This challenge is the complexity of complying with government regulations designed to protect public health and safety. The most notable of these is Title 21 of the Code of Federal Regulations governing Electronic Records and Electronic Signatures (21CFR11). Although 21CFR11 has been in the draft stage for almost a decade, final regulations have recently been created. Enforcement of these regulations is beginning to take place and enterprises are responding with a wide variety of initiatives, both within individual organizations and across industry sectors.
- E-Notebook Enterprise and Document Manager integrate corporate knowledge with regulatory compliance
- Consulting teams analyze and adapt existing procedures to comply with new regulations
- Systems include authentication and digital signatures and adapt to changing regulations and demands
Integrated Software
CambridgeSoft applications, such as E-Notebook Enterprise and Document Manager, are at the leading edge of the integration of corporate knowledge management with 21CFR11 Compliance. These products are designed so that as your organization reviews its internal processes for 21CFR11 Compliance, the software can be configured to support these internal processes. Major requirements of 21CFR11, such as electronic signatures, audit trails, and long-term archiving, are incorporated within the routine workflow to generate the critical information required by research, development and production. In addition, E-Notebook Enterprise and Document Manager can be integrated with existing critical data systems.
Analysis
As your enterprise develops the operating procedures that you will need to adopt for 21CFR11 Compliance, CambridgeSoft's consulting team can provide invaluable assistance in analyzing your current operating procedures, adapting your existing procedures to comply with new regulations, and validating the software and the operating procedures that you will use. CambridgeSoft's consulting teams consist of individuals who have extended experience in deploying systems used by large pharmaceutical companies, emerging biotechs, and major enterprises worldwide.
Implementation
Once you have determined how your enterprise will comply with these new regulations, implementing those decisions needs to be done quickly, efficiently and with the understanding that the rules for compliance are in flux. In order to succeed, you must be able to respond to change. CambridgeSoft's 21CFR11 Compliance consulting has both the tools and the expertise to provide complete solutions, carry out integration with your existing systems, and help you execute the process as quickly as your organization demands. Since ongoing monitoring is a part of business for regulated industries, you can be confident that, as regulations evolve and your requirements change, your systems can adapt. With CambridgeSoft, you can take advantage of the knowledge that has helped dozens of businesses, large and small, gain control over their business processes, their intellectual capital, and their material resources.
