What does it mean to have an FDA title 21 CFR part 11 compliant process? In the simplest terms, it means that any pertinent actions monitored or triggered by the SCADA system must have in place methods to track and record information for retrieval, and enforce procedures to provide a high level of reliability for the information provided by the system. InduSoft Web Studio includes all the tools manufactures need to create CFR part 11 compliant SCADA projects.
The industries most likely to require FDA compliance are the Pharmaceutical industries, as well as an increasing number of food and beverage and water treatment facilities. Here are a few of the ways a good SCADA software can make a project FDA compliant:
Security: Security is a vital aspect of FDA compliant SCADA software. InduSoft Web Studio offers secure SCADA and HMI applications that optionally support Microsoft Active Directory via LDAP. The IWS security system supports groups and users. Users can be assigned to multiple groups. For example, Bill is the supervisor for the machine operators. Bill can be part of the Operator’s group and the Supervisor’s group too. Password strength, aging, E-Signature timeout, auto log off and account auto lock-up are all included with InduSoft Web Studio
Traceability: IWS allows the logging of user activity, creating a trail of accountability for every step of the process. Users can sign in and out, annotate changes, or create notes. Alarm acknowledgement comments are even stored in a database. Electronic signatures are a built-in feature of IWS.
SQL compatibility: Connect to any SQL database in order to store reports, recipe modifications, and create audit trails.
Reports : Use InduSoft to create “non-editable” read only reports and send them directly to a printer, an FTP server, to email, or a smartphone. SCADA software that is capable of issuing hard copy reports is important for Title 21 CFR part 11 compliance.
Events: Track user initiated actions or internal system activity and generate reports with electronic signatures verifying events.