In 1997, the Food and Drug Administration issued 21 CFR Part 11, the Final Rule on Electronic Records and Electronic Signatures (PDF 1, PDF 2). Part 11 applies to all electronic records that are created, modified, maintained, archived, retrieved, or transmitted in companies or departments that work under any kind of FDA regulation, as well as records submitted to the agency under the requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. All GxP-regulated industries (pharmaceutical companies, manufacturers of medical devices, analytical contract laboratories, etc.) must comply with these regulations.
On February 20, 2003, the FDA published a new draft guidance document, stating that it intends to reexamine Part 11 and interpret it narrowly. Regardless of the FDA’s approach to interpreting these regulations, however, electronic records must still be maintained and submitted in accordance with the underlying FDA predicate rules.
Digital images and data are subject to these regulations. Olympus America, Soft Imaging System Corp., and BioMedion have joined forces to create a 21 CFR Part 11-compliant solution for the Olympus MicroSuite™ Software for Imaging Applications.
The ComplianceServer™ and the BioMedion-windream™ electronic data and document management software form the backbone of the GxP and 21 CFR Part 11-compliant solution for the MicroSuite™ software, providing all of the required machine-based functionality of Part 11 compliance in a Windows® (NT4/2000/XP) environment: (PDF1, PDF2)
- Seamless integration with image acquisition and analysis
- Client/Server-based data management system
- Full computer-generated audit trails
- Validated time stamps
- Version control of all files
- Advanced user access management
- Electronic long-term archive option
- Document life cycle management
- Electronic signatures (optional module)
The ComplianceServer™ can function as a stand-alone server for one or more laboratory instruments, or it can be integrated into an existing Local Area Network running Microsoft Windows® NT4 or 2000. On the client side, any operating system from Windows® 95 to XP can be used, although only Windows® NT4 to XP offer the kind of user access control that is necessary for this system to comply with the regulations for fully compliant user authorization and management.
The Starter Kit configuration of the ComplianceServer™ can host up to 5 different laboratory and/or office workstations (clients) simultaneously, one of which is the MicroSuite™ Part 11-compliant imaging software. More client workstations can be added at any time if you obtain additional client licenses. There is no limit to the number of clients connected to the system. It integrates easily with existing and future computerized laboratory equipment.
The ComplianceServer™ can be used for multiple software applications within the same environment. All applications that run under Windows® and all connected hardware devices (such as microscopes and other laboratory equipment) can thus fulfill the technical requirements for GxP and 21 CFR Part 11 compliance (e.g. audit trail, user access management, protection and versioning of raw data, etc.). For full compliance to GxP and 21 CFR Part 11 regulations, you must take additional measures. Click here for details.
The MicroSuite™ Rule 11 module integrates seamlessly with the BioMedion-windream™ software. It provides a 21 CFR Part 11-compliant database which resides on the ComplianceServer™ within the client’s network (the "W" drive). Among other things, access is controlled, and all images, data sheets, diagrams, and text files saved to the database are tracked via audit-trail and version control. They cannot be deleted, and anytime an image is opened for viewing, the user must indicate whether it is being opened as "Read-Only" (i.e. can't be modified) or "For Modification" (whereby a new version is created, and the original remains saved and unchanged).
Summary of Items Included with the ComplianceServer™:
- Server PC with Windows® 2000, including tape back-up system
- Server installation, shipping & handling
- BM-windream™ Starter Kit
- 5 Microsoft SQL Server CAL (Client Access Licenses)
- 1 Rule 11 module for the MicroSuite™ software
- On-Site Installation and validation (IQ/OQ) of BioMedion-windream™
- On-Site BM-windream™ User and Administrator Training
- 1 year of BM-windream™ Technical and Validation Support
- 1 year of Parts and Labor Support for the Server PC
In addition to the basic IQ/OQ validation of the ComplianceServer™, BioMedion independently offers full validation services for digital imaging systems consisting of Olympus microscopes / MicroSuite™ / BM-windream™ (subject to additional charges).
Important Notice: For full compliance with GxP and 21 CFR Part 11, additional organizational measures must be taken in your laboratory. Click here for details.
BioMedion 21 CFR Part 11 Compliant Software
BioMedion-windream 21 CFR Part 11 Compliant Software
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