Seeking information on whether PLC code complies with FDA regulations regarding electronic records and signatures (21 CFR Part 11). Any input on this topic would be greatly valued.
Do you wish to delve into this topic? The truth is, uncertainty reigns – no one holds all the answers. Your query unravels into various layers, and I shall endeavor to navigate through them. While I may not be a Part 11 expert, my company boasts several experts, and my interactions with them have shed light on Part 11 compliance. When it comes to "Electronic Signatures", it's important to note that PLCs are not designed for direct human interaction. Electronic signatures must be obtained via SCADA/HMI systems, which ultimately communicate with humans. Therefore, the responsibility falls on SCADA/HMI to ensure Part 11 compliance. Regarding "Electronic Batch Records", PLCs have limited memory capacity and are not ideal for storing extensive historical data. It is typically the SCADA system that retains vast amounts of information. Even if PLCs were to store batch records over multiple years, data integrity becomes a critical concern in ensuring compliance with Part 11 regulations. An essential aspect of Part 11 involves maintaining an audit trail for electronic records to trace any alterations back to their source. The system must be secure from unauthorized tampering. The ideal Part 11 system operates similarly to an ATM, where transactions are secure, and access is restricted to authorized personnel. Certain ambiguities persist in Part 11 compliance, such as the usage of tokens for electronic signatures. The FDA is yet to provide clear guidelines on whether both tokens must be entered for each transaction or if a single token suffices as acknowledgement. This uncertainty has left pharmaceutical companies and SCADA manufacturers grappling with the best approach. Each pharmaceutical entity interprets Part 11 regulations differently, adding to the complexity of compliance. Ultimately, it is crucial to understand that no PLC can achieve full Part 11 compliance.
I have experience creating PC-based programs that emulate PLCs for pharmaceutical packaging in a major company located in Roanoke, Virginia. This process focused on sealing the container surface, not the product itself. Unfortunately, I am unable to recall the specific company or specification you are inquiring about at this time.
Terry Woods shared his experience of developing PC-based, PLC-Emulating programs for packaging in the Pharmaceutical industry, specifically focusing on container seal surface finishing. This project took place around 1999 when Part 11 was added to 21 CFR. If the packaging line required validation, it would likely fall under cGMP regulations. Many HVAC systems are now undergoing retro-validation due to their impact on product quality. Validation is crucial in ensuring that the product meets its intended specifications and functions correctly.
I believe Allen's response was accurate. While PLC systems cannot achieve compliance with Part 11 regulations, it is the responsibility of the SCADA system to do so. Our company specializes in manufacturing packaging machines for the pharmaceutical industry, equipped with either a SCADA-type HMI or simpler interfaces like Siemens TP170 or Bradley PanelView. These systems all feature password protection, although our clients have deemed this to be sufficient without the need for usernames. Additionally, our machines undergo thorough validation processes, ranging from meeting 2000 compliance standards to considering various sensor failure scenarios. During acceptance inspections, our clients bring in experts from multiple fields, leaving me to handle their inquiries alone. Perhaps it is time to discuss a potential raise with my boss.
PLCs and Compliance with 21 CFR Part 11 When it comes to PLCs, the software is classified as an electronic record according to FDA regulations. However, PLC Software currently lacks compliance in certain areas, such as the absence of an electronic audit trail for changes. PLCs and DCSs play a crucial role in the pharmaceutical industry by automating manufacturing processes, often without the use of SCADA or HMI systems. To ensure compliance, GxP systems must undergo validation, implement security measures to restrict access to PLC code, and establish change control procedures. Regular software checks should be conducted to detect unauthorized changes, and maintaining previous software versions can aid in compliance efforts. While there have been no FDA warning letters specifically targeting the use of PLCs, systems lacking adequate controls are at risk. SCADA systems and HMIs require separate assessments to ensure compliance with regulatory requirements.
While I'm not an expert, I do know that PLC code in itself does not inherently comply with FDA regulations, such as 21 CFR Part 11. However, the way it's used and controlled can be. Part 11 specifically relates to the traceability, integrity and confidentiality of electronic records and signatures, rather than the actual code. Hence, it's the system built around your PLC (like what kind of data acquisition system or SCADA you use) and the SOPs you have in place for its use that would need to comply with Part 11. The PLC code would just be a part of this system. Always best to consult with a regulatory expert or legal advisor for guidance pertinent to your specific situation.
While PLC code itself doesn't inherently comply or not comply with FDA regulations, how it is used and managed can either comply or not comply with 21 CFR Part 11. The key factors to consider in terms of compliance are whether the electronic records created by the PLC can be reliably used in place of paper records and whether the electronic signatures are trustworthy, reliable, and essentially equivalent to handwritten signatures in terms of the legal implications. Additionally, an audit trail ensuring traceability is essential. Therefore, your focus should be on how the PLC code is integrated into your system, how document control is maintained, and how electronic signatures are managed.
While I'm not an expert, my understanding is that PLC code in itself isn't specifically regulated by the FDA. What the FDA does regulate, under 21 CFR Part 11, is electronic records and electronic signatures. So it's about how the PLC code is applied - for instance, if your PLC code is being used to manage or document processes or controls in a FDA-regulated industry then that code, along with how it's used and maintained, would need to comply. It's a complex topic and I'd suggest consulting with a compliance expert to ensure everything is up to par.
While the PLC code itself isn't directly overseen by FDA regulations such as 21 CFR Part 11, it contributes to systems that could be. Keep in mind that 21 CFR Part 11 focuses more on ensuring accuracy, reliability, and consistency of electronic records and electronic signatures. It aims to ensure that these records and signatures are trustworthy and equivalent to their paper counterparts. As such, the elements of your PLC code that interact with electronic records and signatures should be designed to adhere to these requirements - meaning that they should facilitate record keeping and signature capturing in a secure and verifiable way. It's advisable to consult with a compliance expert to make sure your specific application aligns appropriately with the regulations.
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Answer: 1. What are the key considerations for ensuring PLC code compliance with FDA regulations, specifically 21 CFR Part 11? - The key considerations include ensuring electronic records are secure, accurate, and accessible, along with implementing controls for electronic signatures and audit trails.
Answer: - The pharmaceutical industry can ensure compliance by following best practices such as validation of PLC code, maintaining documentation, implementing security measures, and training personnel on compliance requirements.
Answer: - Yes, the FDA's 21 CFR Part 11 provides specific regulations for electronic records and signatures, which apply to PLC code used in the pharmaceutical industry.
Answer: - Non-compliance can lead to regulatory action, fines, product recalls, and damage to the reputation of pharmaceutical companies. It is essential to adhere to FDA regulations to ensure patient safety and data integrity.
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