Are you using a US FDA 21, CFR Part 11 and GAMP 5 compliant system?

Table of Contents

• What is US FDA 21 CFR Part 11?
• Why is US FDA 21 CFR Part 11 Critical for Pharmaceutical Leaders?
• What is GAMP 5?
• Why is GAMP 5 Compliance substantial for Pharma Leaders?
• 100 % Compliance Guaranteed – TSA 
• Conclusion
• FAQs

Yes, it is an important question to answer. As we witness rampant technological advances every passing day, regulatory authorities gain awareness of possible tampering with the data and unauthorised access to it. Such fraud can also result in warning letters, penalties, and product recalls. This, in turn, affects the brand’s hard-earned reputation. 

Additionally, the US FDA 21 CFR Part 11 and GAMP 5 guidelines encourage using automation systems to ensure product quality and patient safety. Here, we discuss the fundamentals of their principles and the significance of their compliance with the pharma leaders. 

What is US FDA 21 CFR Part 11?

The U.S. Food and Drug Administration (FDA) established the 21 CFR Part 11 regulations in 1997 to ensure the accuracy and reliability of Electronic Records and Electronic signatures and their equivalency to paper records and handwritten signatures. The pharma, biotech and other industries that rely on digital systems for documentation, data management, and regulatory submissions must comply with 21 CFR Part 11. 

The Key requirements of 21 CFR Part 11 are: 

1. Electronic Records:

• According to the 21 CFR Part 11, the systems that create, modify, and maintain electronic records must be validated to ensure accuracy, reliability, and consistency. 
• One must opt for secure, computer-generated audit trails to record the essential details like date, time, and any changes to the record. 
• These electronic records must be maintained for a required period and should be readily available at the time of inspection by the FDA. 
• The systems must be well protected to prevent unauthorised access to records and to safeguard the records from deletions or alterations.

2. Electronic Signatures:

• The electronic signatures must be unique to every individual. An Organisation must have processes to verify the identity of an individual who uses an electronic signature. 
• The electronic signatures must be linked to the signed document to track accountability easily. Such a document must include essential details, including the signature’s name, date, and meaning (e.g., approval, review ).  
• An Organisation must certify to the FDA that electronic signatures are legally binding equivalents to handwritten signatures. 

3. System Access:

• System access must be managed strictly to allow access only to authorised individuals. One can use robust password management and authentication methods. 
• Every action performed in the system by an individual should be traceable. 

4. Operational Controls:

• Operational checks must be performed to affirm that the steps or events within the system are in the correct sequence. 
•  One needs to perform Device Checks to verify the functionality of the devices, such as computers and sensors, used in the electronic record-keeping process. 

5. Digital Signature Requirements:

Biometrics or Two-Factor Authentication must be implemented to prevent the fraudulent use of electronic signatures. 

Why is US FDA 21 CFR Part 11 Critical for Pharmaceutical Leaders?

It ensures that the electronic system used by pharmaceutical companies complies with stringent data integrity, security, and traceability standards. 

Here are the reasons why Pharma Leaders are obliged to follow it: 

1. Data Integrity and Trust: Since Part 11 sets the foundation to ensure the accuracy and reliability of the electronic records, it also makes them tamper-proof. The regulation helps to gain and maintain the trust of the regulators, partners, and patients. Compliance with this regulation guarantees data integrity, which is essential to delivering high-quality and safe products. 
2. Regulatory Compliance: If a company fails to comply with 21 CFR Part 11, it can lead to regulatory actions such as warning letters, fines, or product recalls. By prioritising compliance, pharma leaders can protect their organisations from costly legal matters and damaging the brand’s reputation. 

TSA’s Purified Water Generation System is Compliant with U.S FDA 21 CFR Part 11 and GAMP 5. 

1. Operational Efficiency: Besides ensuring the brand’s reputation, the regulation also helps improve efficiency as it promotes streamlining operations and reducing manual paperwork, making data retrieval easy. In this fashion, it also supports faster decision-making and real-time data access. 
2. Global Market Access: Since the FDA is a globally leading regulatory authority, compliance with 21 CFR Part 11 opens up entry gates into the International Markets. 

What is GAMP 5?

The GAMP 5 is the updated version of Good Manufacturing Practice, developed by the International Society for Pharmaceutical Engineering (ISPE) in 2008. This framework is a practical guideline for designing, implementing, and managing automated systems. It covers the entire system from concept to decommissioning. 

Here are the Key Principles of GAMP 5:

1. Risk-Based Approach: 

• GAMP 5 focuses on a risk-based approach to compliance; the organisation must identify and control risks to product quality, patient safety and data integrity. The company must conduct formal risk assessments like FMEA and HACCP to determine the level of testing and validation required depending on the system’s potential impact on patient safety and product quality. 
• There must be appropriate controls depending on the identified risks. The highly critical systems require to be thoroughly validated. 

2. System Life Cycle Approach (SLC)

• The GAMP 5 supports the management of computerised systems throughout the concept, development, validation, operation, and retirement. The systems also need to be reviewed and improved per the changes in the regulations, evolving business needs and technological advancements. 

3. Scalable Validation

• GAMP 5 also supports using a scalable validation approach depending on the system’s complexity, criticality, and risk. 
• Organisations can also use Supplier and Vendor Documentation like Factory Acceptance Testing to minimise duplication and streamline validation efforts. 

TSA’s Pure Steam Generation System complies with 21 CFR Part 11 and GAMP 5. It also provides additional support like Cleanroom FAT facilities, Validation Documents and more. 

4. Category-Based Software Classification

To determine the appropriate validation strategy, GAMP 5 has classified software: Infrastructure Software (Operating systems), Non-configurable software (standard software packages with no customisation), Configurable Software, and Custom Software. The Custom software requires maximum validation efforts. 

5. Documentation and Traceability

• GAMP 5 underscores the significance of well-defined documentation, such as User Requirements Specification (URS), Functional Specifications (FS), Design Specifications (DS), and testing documentation (IQ, OQ, PQ). 
• It is essential to use a traceability matrix to guarantee all the user requirements are tested and covered in the validation process, proving that all the systems function as intended. 

6. Quality by Design

GAMP 5 encourages the design of high-quality systems to comply with the standards right from the early developmental stages and reduce the risk of failure and deviations later. 

It also emphasises user involvement to ensure the system meets the business needs and regulatory standards from the start of the process. 

7. Data Integrity and Data Governance

The GAMP 5 guidelines are in alignment with other regulatory expectations like the US FDA’s and EU’s guidelines affirm the integrity of electronic records, including the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available). It suggests implementing secure, computer-generated audit trails to secure the digital records and track any changes.

Why is GAMP 5 Compliance substantial for Pharma Leaders? 

For pharmaceutical leaders, GAMP 5 compliance is essential for the following reasons:

1. Regulatory Alignment: Since GAMP 5 aligns with other global regulations like FDA and EMA, its compliance guarantees that the system is audit-ready and meets the safety, quality, and data integrity requirements. 
2. Risk-Based Focus: As GAMP 5 emphasises a risk-based approach, it allows the Pharma Leaders to focus validation efforts on the systems that directly influence product quality and patient safety. It helps to address the risks efficiently and streamline processes, reducing downtime. The leaders do not need to overburden their teams with unnecessary validation tasks.
3.  Ensuring Data Integrity: Compliance with GAMP 5 confirms that the computerised systems generate accurate, reliable, and secure data, which is paramount for decision-making and regulatory submissions. 
4. Enhancing Operational Efficiency: By implementing GAMP 5, pharmaceutical companies can adopt advanced technologies while ensuring compliance. Automation and innovative systems that comply with GAMP 5 standards reduce manual interventions, accelerate production cycles, and improve overall efficiency, giving companies a competitive edge in a fast-evolving industry. 

Following GAMP 5 is crucial for validation systems like Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and Quality management systems (QMS) typically used in the pharma industry. 

100 % Compliance Guaranteed – TSA 

At TSA, we meticulously design High-Purity Solutions and Process equipment that comply with US FDA 21 CFR Part 11 and GAMP 5. We offer premium products at affordable costs to the pharma, biopharma, biotech, and other industries. 

Our team of experts come from your table and speak your language. We support the Pharma Leaders in staying ahead of the curve by providing Validation Documents and Cleanroom FAT Facilities to ensure hassle-free audits. 

What’s More?

We also assist you in following the GAMP 5 regulations regarding automation. TSA’s engineers design comprehensive, reliable, and easy-to-operate automation systems. The automation systems connect, streamline, and sequence the processes seamlessly, ensuring all the equipment works harmoniously. At TSA, we treat risk assessment as a critical input to decide the extent and effort required for validation. This enables us to dovetail automation into our scope regarding qualification and audits, resulting in minimum changes on-site. 

Visit our official website to explore all the 21 CFR Part 11 and GAMP 5 compliant systems.

Conclusion

As we conclude this discussion, we would like to emphasise the importance of selecting a system that complies with US FDA 21 CFR Part 11 and GAMP 5 to ensure product quality and patient safety. As the saying goes, ‘A friend in need is a friend indeed,’ and TSA is your reliable partner. We are available 24/7, ready to listen to your challenges and craft tailored solutions. Contact us Now!

FAQs

1) What documentation is needed to prove compliance with 21 CFR Part 11 and GAMP 5?

Documentation like system validation reports, audit trails, user access logs, data integrity records, electronic signature records, and system operating procedures are necessary. Comprehensive documentation demonstrates that your systems are compliant and validated.

2) Can we use cloud-based systems while complying with 21 CFR Part 11 and GAMP 5?

Yes, cloud-based systems can comply with 21 CFR Part 11 and GAMP 5, provided the cloud provider offers the necessary security features, audit trails, and validation support. It’s essential to work closely with the vendor to ensure the system meets regulatory requirements.

3) How do I choose a vendor for a 21 CFR Part 11 and GAMP 5-compliant system?

Look for vendors with a proven track record in compliance, experience in the pharmaceutical industry, and strong support for system validation and training. TSA Process Equipment has been a leading company in the pharma market for two decades now. The experience and the expertise we hold are unparalleled. Our systems comply with the world’s most stringent standards, including 21 CFR Part 11 and GAMP 5. 

4) What is the difference between validation under GAMP 5 and qualification?

Validation refers to the documented process of ensuring that a system consistently meets its intended purpose (e.g., for manufacturing). In contrast, Qualification refers to specific checks on equipment or processes, ensuring they function correctly. GAMP 5 provides a risk-based framework for both.

5) How can automation help with compliance under 21 CFR Part 11 and GAMP 5?

Automation helps reduce human errors, ensures data integrity through electronic records, and simplifies processes like audit trails, system validation, and user access management. Automated systems are often more reliable and efficient in meeting regulatory requirements.