OpenPro and FDA Compliance
21 CFR Part 11 Compliance Table for all OpenPro Products
Comply with FDA Standards
Limit your risk of non-compliance, improve your quality of data and reduce costly data entry requirements by implementing our barcoding and lot traceability features.
Software programs alone cannot design and maintain an FDA conformant quality management system.*
However, our OpenPro ERP Manufacturing Inventory Control software can help automate many aspects of your quality management system.
FDA’s new Quality System regulations make standards for American medical devices consistent with quality system requirements worldwide. The new standards closely follow the international standard, ISO 9001, and fulfill a mandate of the Safe Medical Devices Act of 1990.
OpenPro’s ERP software can help your business meet FDA Document Control Requirements.
- Batch or Lot traceability from supplier through production to customers;
OpenPro ERP provides easy historical query of specific lot or batches
- List the suppliers or processes the recalled batches or lots originated from
- List the products the recalled batches or lots were used in
- List the customers who received the recalled batches or lots
- Expiration dates … unit-of-use barcodes, automated entry and tracking of expiration dates:
leads to better stock rotation and reduced losses from expired products.
Including expiration dates with sales records improves customer service.
Maintain the required knowledge base as a basis for the product design
- Establish adequate batch production and control records for each batch or lot produced;
include documentation of each significant step in the manufacturing, processing, packing
and holding processes.
- Establish procedures for Inventory Control, acceptance/rejection testing, etc.
- Production Control and Processes Validation
- Identification and Traceability
- Electronic Signatures Rule: encoding lot numbers, marrying with production records.
This data is extremely helpful for recalls, but is also used for process analysis and quality control.
*OpenPro ERP Inventory Software provides programs that when properly used are helpful in qualifying for FDA certification. OpenPro, Inc. makes no claims that its ERP Inventory Software will guarantee FDA certification or conformity.
OpenPro ERP is the most cost-effective way to control your inventory, production and profits.
|Subpart B – Electronic Records|
|Sec. 11.10 Controls for closed systems|
|11.10||Elaborate security controls and audit trail to ensure the authenticity, integrity and confidentiality of electronic records.||YES|
|11.10(a)||The 21CFR11 compliant products have been developed and validated using FDA guidelines. The software rejects invalid data.||YES|
|11.10(b)||There is a variety of means to generate copies of records in human readable for suitable for inspection, review and copying. The System Administrator should ensure that all system generated data files, reports and plots are read-only. The 21CFR11 compliant products generated audit trail records are read-only.||YES|
|11.10(c)||Records are protected by restricting access to authorized users. The programs use the 21CFR11 compliant access levels to control the flow of information.||YES|
|11.10(d)||The 21CFR11 compliant products provide a multiple level of password control. Individual levels of authorized access include: User, Supervisor, and Maintenance.||YES|
|11.10(e)||A comprehensive audit trail should capture all significant user actions and system conditions, including actions that create, modify or delete data or user ID/passwords. Audit trail records include date, time, user ID, printed name of the user, action, and reason for action. Audit trail files can be copied and printed out.||YES|
|11.10(f)||The System Administrator should make sure that only permitted sequences of steps are allowed.||YES|
|11.10(g)||All functions should check access authority.||YES|
|11.10(h)||The source of data should be verified through electronic means.||YES|
|11.30||This version of the 21CFR11 compliant products is designed for closed systems.||N/A|
|11.50||This version of the 21CFR11 compliant products does not use the electronic signatures of electronic records.||N/A|
|11.70||This version of the 21CFR11 compliant products does not use the electronic signatures of electronic records.||N/A|
|Subpart C – Electronic Signatures|
|11.100||This version of the 21CFR11 compliant products does not use the electronic signatures of electronic records.||N/A|
|11.300 – Controls for identification codes/passwords|
|11.300||The 21CFR11 compliant products provide a multiple level of password control. Individual levels of authorized access include: User, Supervisor, and Maintenance.||YES|
|11.300(a)||System requires that each User ID and password combination is unique.||YES|
|11.300(b)||Password aging feature is enabled. If password has expired, a user with proper authority is required to enter a new password for a unique user name and password combination.||YES|
|11.300(c)||Supervisor and Maintenance level access has authority to disable user accounts and to reset passwords.||YES|
|11.300(d)||3 or more invalid login attempts are recorded in audit trail.||YES|
* Password protection
* The levels of authorized access include: User, Supervisor and Maintenance
* Operator can do any routine task of the host program
* Supervisor can do everything Operator can do plus add/edit/delete User Names / Passwords and display Audit Trail (current & historical)
* Maintenance Users can change system settings, such as calibration, etc.
* All major activities are governed by access level control
* Username is case insensitive, password is case sensitive
* Passwords are required to have at least 6 characters, including 1 numeric and 1 alpha
* Logout results in an immediate Login screen
* Password aging feature. The length of aging period is under the System Administrator’s control
* Proper log in or program termination is required after a period of inactivity. The length of such period is under the System Administrator’s control
* Failed password logins trigger audit trail
* Usernames and passwords are stored in an SQL Database that is itself encrypted
* Assured uniqueness of every username – password combination
* User friendly password control that allows multiple sessions of add / edit / delete
* Authorization (special login) required for password control (Authorizing User is not necessarily the Current User)
* Master Password for system administration and maintenance
* Audit Trail: designed to record important actions, including modification of files and folders. All major actions are governed by audit trail control.
* New Audit Trail file is created each time the program is run. The System Administrator can specify the folder for Audit Trail files.
* Audit Trail files are tagged / named with the use of Date and Time of creation.
* Audit Trail file maintenance (backup, deletion) should be governed by procedural control (SOP).
* Some user actions may require a reason for entry. The program does not proceed until the reason for change is given.
* All vital data and reports have read-only attributes.
* Touch Screen functionality is optionally enabled.
* All MCC products are closed (stand-alone) systems.
We shine when it comes to implementation and a smooth transition. From the beginning, you will be assigned an experienced Enhanced Systems’ consulting team member as your primary coordinator to orchestrate our broad range of services. In addition to focusing the work, this makes your job easier by giving you a single point of contact to get you the answers you need as you need them. And we work fast – it typically takes us just 30 to 60 days to initiate a live production. The next job is to establish OpenPro in your existing business environment. Our Implementation Program combines education, implementation consulting services and proven methodology to help you take advantage of the OpenPro system’s powerful capabilities right from the start. It’s a process that takes careful planning and collaboration. As you work with our highly skilled Implementation Consultants, you will see how quickly and easily you can achieve the results you want.
Following software installation, our technical consultants will help you train your staff for ongoing tasks such as installing additional modules, handling print documentation on demand and using an array of OpenPro installation tools. We will also help you set up security and establish users and peripheral devices (such as printers) on your OpenPro system.
And, if you are like many of our customers who have a lean IT staff or may not even have one at all, you will find that our experts are an invaluable resource for additional help with your technical decisions throughout the transition and beyond.
Our long-term commitment for your long-term benefit. Our commitment to long-term partnerships is most evident in our range of continuing support services. To keep your system running effectively and efficiently over time, we offer a comprehensive program of periodic reviews and consulting.
Implementation is often a good time to review business practices and re-engineer them in light of your new objectives. We can help each of your teams through this key process and provide the technical assistance your IS team needs as well as intensive hands-on training and practical expertise, all with a very personalized approach.
EDUCATION and TRAINING
In addition to basic technical skills, we provide a complete instructional package tailored to your needs. Early sessions include system basics, navigating applications, functionality and simulations. We can also incorporate more comprehensive skills with each user group based on their need.
No Enhanced Systems service is ever generic. Unlike other companies, we learn each functional area within your industry, company and the tasks each person needs to do, and we train on those specific tasks. So, instead of the large group classes of others, we teach your staff in small groups or one-on-one. This greatly reduces training time and costs and increases retention, because your people learn only what they need to know.
Every system conversion involves bridging the old system to the new no matter what the old system is. Part of our implementation system support for your IS team includes discussing and demonstrating data manipulation techniques as needed. This additional support can prove invaluable in making a timely and successful cut over.
Over the years, we have tackled some very challenging conversions, including converting data from a long-discontinued Winchester drive the manufacturer no longer supported. Even then, we captured the data and got the client up and running quickly and smoothly.
In addition to knowledgeable phone support, we offer pager facilities for emergencies and dial-up modem to expedite technical diagnostics. In most cases, you can count on resolving your situation with one contact. Ongoing support service is strongly recommended to make sure you get the most out of your OpenPro system.
NEW VERSIONS AND UPDATES
OpenPro is constantly evolving with latest best practices, technologies and functionality. Our updates and new versions come from our observations, customer and manufacturing industry ideas and government requirements. Unlike many larger vendors, our size allows us to incorporate new functions, technologies and changes much faster than many others. In fact, we will often incorporate new customer requirements prior to the system’s purchase.
Although most customers find the OpenPro system meets 90% or more of their requirements, we can also perform specific software modifications. If other customers can benefit from your change, it will be incorporated as a standard OpenPro enhancement and we will support it as part of your standard maintenance agreement.
We focus exclusively on the projects-oriented manufacturing industry, so OpenPro often delivers a 90% or better fit right off the shelf. Best practices indicate initially using the OpenPro system in its original version. After live production, most users find that they no longer require the software modifications they thought they would need. When modification is still required, we work closely to understand and meet customer requests efficiently and in a cost-effective manner.