Med Device EDMS Q.C.B.D. Customization and Validation
Q.C.B.D or “Quality Collaboration By Design” is a software system produced in California by CAMA Software. QCBD is a simple, yet effective, and cost-conscious electronic document management system (EDMS). This software can be implemented to manage Electronic Records in a Medical Device, Biologics, or Pharmaceutical manufacturing environment. This system is fully 21 CFR part 11 complaint and also contains module which satisfy all 21 CFR part 58, 210, 211, and 820 regulations. The QCBD system is also ideal for any manufacturing organizations following ISO 9001 or 13485 standards.
Sundial IT is CAMA Software’s only Preferred Vendor/Partner Program Member in San Diego County. Extensive information on the software is available on CAMA’s website at http://camasoftware.com
We are able to install, customize, implement, and validate the QCBD system. We are able to assist with customizing each module to fit individual business processes and needs. Sundial can also assist with customizing the out of box CAMA provided Validation Protocols to fit the needs of any organization.
Sundial can provide history and proof of previous Part 21 CFR-compliant implementations of QCBD including two-step authentication and examples of previously customized validation protocols. The QCBD includes validation protocols for each individual module within the software. Parts, or all of the modules with associated validations can be customized to fit your business needs while retaining functionality to comply with 21 CFR part 11. The areas of functionality and customization for each module are clearly explained within the out of box QCBD software configuration. This is one of the best features of the QCBD software.
QCBD provides value and convenience that any company can afford. QCBD has options to fit any budget with pricing starting for as low as $4,000. The Software includes;
- Multi-user application
- Unlimited concurrent users
- No per user or per workstation license fees
- No annual maintenance fees
- No hardware to purchase – install on your existing server environment
- Options to purchase only the modules you need
- 24 hour training and support
Setup and implementation time is VERY quick compared to more complicated software, averaging about two months. The biggest mistakes that small businesses make is wasting time in the implementation of their EDMS without actualizing any return on their investments. 9 times out of 10 the implementation aspect of an EDMS is overkill for manufacturers with less than 300 employees.
QCBD is ideal for managing revisions of documentation / engineering changes, keeping a change history, having 21 CFR part 11 compliant audit trails. The full QCBD software includes the following modules; Vendor Management, Equipment Management, Training Management, Change Control, Complaint Management, Corrective Action, Nonconformance Reports, and more.
QCBD is available in two versions: an entry level that uses a simple Microsoft Access database that is sufficient for almost any size business operating a single manufacturing site. The second level uses an MS SQL database and is more appropriate for users with very large record volumes (100s of thousands or millions) and operating multiple manufacturing sites with VPN connectivity.
ADD TABLE WITH TWO OPTIONS
QCBD Standard Edition
- Network database application that runs on your Local Area Network (LAN). The cost effective solution for small companies.
- Local area network, file sharing (MS Access database)
- Single site, multi-user environment
- Unlimited named users
- Up to 50 concurrent users
- Low maintenance. Requires minimal IT support
- Scalable – easily upgrade to the Enterprise Edition as your company grows
QCBD Enterprise Edition
- Client-Server database running over your wide-area network (WAN). Access your data from anywhere in the world. The ideal solution for mid-size to large companies with multiple locations.
- Wide area network, Client-Server (MS SQL Server database)
- Multi-user, multi-facility environment
- Unlimited named users
- Unlimited concurrent users
- Share data across many sites/facilities
- Additional hardware/software purchases may be required. (MS SQL (Server 2005 through 2014, all editions) and server hardware are not included in purchase price.)
|Typical Implementation Schedule:|
|Assess readiness to implement an EDMS.|
|Recommend and implement server and network upgrades if necessary.|
|Meet with Quality, Regulatory, Engineering, and Manufacturing departments about expectations of EDMS implementation.|
|Determine is the MS Access or MS SQL edition is appropriate depending on requirements.|
|Install server-side QCBD|
|Work with departments to customize modules in test database.|
|Pre-validate and validate functionality in test database.|
|Copy to live database and rollout to users.|
Does QCBD run in the cloud?
No, QCBD is a simple, lightweight program that runs off a local server in your office. This keeps initial and yearly costs much lower than cloud equivalents. You do not need an overly expensive server to run this software, although we highly recommend Solid State or SSD drives to host your database and file attachments.
Can QCBD run in multiple locations?
QCBD’s Enterprise Editions, which uses Microsoft SQL Server, can operate across multiple locations assuming you have VPN connectivity. QCBD cannot run in the cloud or sync over the internet. Running multiple locations can be useful for manufacturers who operate separate office and production sites.