Doing business in our increasingly connected world presents the pharmaceutical industry with some daunting challenges. Market forces and government regulations are pushing companies toward higher levels of automation and information access.
In an effort to compress R&D cycles, accelerate time-to-market, and reduce costs, the pharmaceutical industry is turning to web-enabled technologies for everything from research collaboration to on-line clinical trials. At the same time, requirements for information security and privacy continue to become more and more stringent.
Protecting intellectual property, guarding the integrity of records, and maintaining the confidentiality of patient data is no longer a matter of keeping lips sealed and file cabinets secured.
Today's electronic information is under increasing threat of attack from hackers, disgruntled employees, and other perpetrators of security breaches.
Also, current federal laws - principally the FDA's 21 CFR Part 11 and the Health Insurance Portability and Accountability Act (HIPAA), impose serious consequences on pharmaceutical companies that fail to protect information stored in electronic databases and accessed across private or public networks.
The pharmaceutical industry is affected most directly by Part 11. These rules were designed to prevent fraud while encouraging the use of electronic documents and electronic signatures to reduce the cost and streamline the process of developing, testing, and manufacturing new life-saving and life-enhancing drugs. Such automation accelerates information exchange, saves storage space and trees, reduces human errors, enables more extensive data analysis, greatly facilitates information searches, speeds manufacturing, and improves process control.
DynamicPolicy can help meet your Part 11 requirements and controls to ensure:
Authenticity: DynamicPolicy supports LDAP (Active Directory) and Sun Service Directory to easily integrate with your user database to manage Authenticity.
Integrity: DynamicPolicy has an embedded SQL-compliant database that verifies and archives the integrity of each document stored.
Confidentiality: DynamicPolicy supports SSL running on an IIS web server to ensure encrypted transmission of data. In addition, the application has confidentiality options to publish documents to specific audiences only. Confidentiality can be controlled by individual and/or group permissions.
Authorization: DynamicPolicy controls authorization through permissions, which are usually given to the individuals who participate in the content development process and management of information. By default, the application provides users read-only permission.
Accuracy and Reliability: With DynamicPolicy's life cycle methodology, companies can ensure that each document passes through a stage of creation, review, approval and publication.
Audit Trails: Each policy, process, and procedure published with DynamicPolicy retains a complete history of the document, including dates and times, the document was created, reviewed, approved and published, as well as the names of authors, reviewers, approvers, publishers, and the target audience of the document.
We invite you to learn how your company can save time and resources during the process of managing your policies and procedures. Request a demonstration today!