Latest version of industrial automation software has been designed to not only meet the FDAQ requirements but also the increasing demand from other industries
Industries that need highly secure monitoring and control systems, including those in food, drink, pharmaceutical and related industries affected by FDA 21 CFR part 11 regulations, can now benefit from Prodigy's 'one tick' approach to compliance.
The latest version of Prodigy industrial automation software has been designed to not only meet the requirements of the 21 CFR part 11 regulations but also the increasing demand from other industries for higher levels of control system security and traceability.
With complex Windows PC applications it is often difficult and time consuming to validate the finished system to ensure compliance with the regulatory requirements.
With Prodigy, user security, data security and audit trails are all built in.
Each security element can be individually configured, or by ticking a single check box Prodigy will automatically configure the entire application to comply with the mandatory regulatory requirements.
This makes it simpler for users to achieve compliance with 21 CFR part 11 and gives users not bound by the regulations flexible options to implement any level of security they require.
User security has been enhanced in line with the FDA requirements.
In particular user passwords can be forced to a minimum length and to expire at regular intervals, repeated invalid access will automatically invalidate the users account and the system can automatically log off an inactive user to prevent the system being left open inadvertently.
Prodigy's audit trail generates an individual time stamped record of every user action that makes a material change to the system.
A built in audit trail viewer with filtering, sorting and printing options can be used to easily identify changes that have been made.
To ensure absolute data security strong 128-bit file encryption is employed for all internal data and configuration files.
No commercial software package exists that will allow data in these files to be decrypted or tampered with.
Industry standard file formats such as Microsoft Access databases are securely password protected in such a way that no human knows the password and only Prodigy may open and present the data enclosed.
Another feature of Prodigy's approach to security for 21 CFR part 11 is the provision of a secure file browser.
The standard Windows file browser allows options that are often best prevented.
For instance these include the ability to delete, rename or copy files, launch programs or to browse to other areas of the computer.
Prodigy's secure file browser options can be configured so that such security loopholes can be controlled or eliminated.
Prodigy also provides complete and flexible options to configure desktop lockdown on the computer that it runs on. Depending upon security requirements this can prevent the users of the Prodigy system from gaining access to Explorer, system tools, games, the internet, network resources and so on.
This kind of lockdown is recommended in many application areas where you want to prevent tampering with the system, either intentional or otherwise.
These features make Prodigy one of the most secure Scada packages currently available and make it an ideal choice for any company that has to comply with 21 CFR part 11, Current Good Manufacturing Practices (cGMP), Gamp and GLP regulations or requires systems with high security and traceability.
Prodigy is widely used for industrial monitoring control and automation applications and combines all the facilities needed for HMI, Scada and DCS in one integrated package.
In addition to the standard Scada functionality it offers an extensive range of dedicated facilities including SPC, downtime monitoring, expert data system, multigraph, on line maintenance, automatic test sequence, etc 21 CFR part 11 is available in version 7 of Prodigy.
Users of earlier versions can add the facility simply by upgrading to the latest version.
