BC [M] FDA Module
Companies in the pharmaceutical, biotech and medical device industries are continually looking for innovative ways to bring new products to market faster. It is critical to maximize market success and lower product liabilities by reducing the risk through validation and maintaining compliance with government regulations.
BlueCielo Meridian Enterprise with the FDA Module is an out-of-the-box business solution that manages current good manufacturing practices (cGMP) engineering documentation throughout the enterprise. With the specific FDA capabilities on top of the core BC Meridian environment, safety & health risks are minimized, compliance is ensured and costly recalls can be avoided.
FDA 21 CFR Part 11 Compliance
BlueCielo Meridian Enterprise and the FDA Module fully support 21 CFR Part 11 by providing the necessary technical controls. Part 11 enables pharmaceutical companies to handle electronic records equivalent to paper records and handwritten signatures. The rule applies to all industry segments regulated by the US Food and Drug Administration and includes good laboratory practices (GLP), good clinical practices (GCP), and current good manufacturing practices (cGMP). The regulation establishes requirements to ensure that electronic records and signatures are trustworthy, reliable, and generally equivalent substitutes for paper records and traditional handwritten signatures.
Secure Access to Engineering Information
With use of the FDA Module, BlueCielo Meridian Enterprise also provides a "single source of truth" - a central, secure repository with exact roles and privileges for authorized users. All security rules, such as notification, inactivity period, separate application login and electronic signature passwords, password length, rotation, expiration, and number of retries can be configured and are audited.
Lifecycle and Validation Documentation
It is mandatory in a highly-regulated environment to validate your IT systems and provide the appropriate documentation indicating that the system was tested and meets user requirements as well as the system specifications.
BlueCielo Meridian Enterprise with the FDA Module provides the ability to configure documents and workflow transitions that require electronic signatures from authorized users. The user is prompted for the required username and password, and the action is logged to the application's audit trail. Users can also delegate the signing task to other authorized users. Invalid signing attempts are logged to the audit trail and the system administrator is subsequently notified. Document status is automatically tracked as well as signature approvals. Upon a successful signing, the appropriate metadata is updated, and the signature information, including the user's full name, current date and time, and reason for the signature are embedded within a PDF rendition of the document (through use of the BlueCielo Publisher). Additionally, a signature page can be configured with the same information.
BlueCielo Meridian Enterprise offers organizations that follow cGMP practices a way of controlling printed documentation. Printed documents contain clearly visible banners that indicate the restrictions on the use of the document. The banners can be placed within the headers or footers of documents.
BlueCielo Meridian Enterprise's integrated solution for pharmaceutical companies provides the following benefits:
- Improve Compliance Effectiveness When using content management solutions by BlueCielo, companies can automatically incorporate greater control in their document handling and administration, minimizing risk and reducing errors.
- Reduce Validation Effort Based on experience in implementations around the world, BlueCielo's out-of-the-box, industry-specific FDA Module includes features that are proven and tested.
- Improve Document Workflow throughout the Enterprise BlueCielo Meridian Enterprise provides secure access to current (as-built) engineering data and other technical documentation throughout the enterprise. By enforcing an automatic workflow, efficiency of design, production, and maintenance operations is increased.
- Lower Cost of Ownership By using BlueCielo Meridian Enterprise you can dramatically enhance the return on investment of your existing IT infrastructure.
- Your Bottom Line With BlueCielo Meridian Enterprise and the FDA Module industry template for the pharmaceutical, biotech and medical device industries, companies can bring products to market faster. This will boost revenue and reduce costly errors while fully complying with FDA Rule 21 CFR Part 11 and other governmental regulations.