The 21 CFR SCADA System is a best-in-class system that has been developed to help pharma industry companies meet the stringent requirements of the FDA's 21CFR Part 11 regulations.
The system uses a combination of hardware, software and human factors engineering principles to create an environment that provides security and ease-of-use by allowing you to send electronic documents through secure channels without compromising quality or timeliness.
21 CFR Part 11 SCADA
21 CFR Part 11 is a regulation that governs the electronic record keeping and electronic signatures in the pharmaceutical industry. The 21 CFR Part 11 SCADA system is used to monitor and control the process of manufacturing drugs and other pharmaceutical products.
21 CFR Part 11 SCADA software includes an options for configuring custom HMI screens, integrating external devices such as PLCs, sensors, valves etc., generating reports from collected data, transferring data to computerised maintenance management software (CMMS) or enterprise resource planning (ERP) systems etc.
Use of 21 CFR in the pharma industry
21 CFR SCADA is a regulatory standard that applies to electronic records and electronic signatures that are used in regulated industries, such as pharmaceuticals and medical devices. These types of industries must ensure the integrity, accuracy, completeness and non-alteration of their electronic records for compliance with 21 CFR Part 11 requirements.
SCADA systems can be used to achieve these objectives:
- Audit trail generation: recording who made changes to what data at which time;
- Data authentication: ensuring that a change was made by only one authorised user;
- Protection against modification or tampering during transmission over public networks (i.e., internet).
Electronic Signatures
Electronic signatures are legally binding and enforceable in the US. This can be demonstrated by a few points:
- Section 101(c) of the Electronic Signatures in Global and National Commerce Act (E-SIGN) says that electronic signatures are “attestations, validations, or authentications created, executed, originated or transmitted” using electronic means.
- This law was passed by Congress on June 30th 2000, making it a federal law that is legally enforceable across all states.
- The Uniform Electronic Transactions Act (UETA), which was enacted by every state except Louisiana and New York, also states that electronic signatures are legally binding on contracts between two parties if they have agreed to use them in their communications with each other.
Conclusion
21 CFR SCADA is an extremely important technology for the pharmaceutical industry. It can help companies meet regulatory requirements while also improving their business processes.
Source : 21cfr Scada System For Pharma Industry Using Hmi And Scada
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