BITSPEC Lean Six Sigma certification’s Post

Is your system really 21 CFR Part 11 compliant? Validating computerized systems is essential for regulated industries like pharma, biotech, and medical devices. It ensures electronic records and signatures are secure, traceable, and FDA-ready. ✅ Key focus areas: -Clear Validation Plan and documented IQ/OQ/PQ testing -Strong audit trails, access controls, and training -Continuous lifecycle management to maintain compliance Proper validation isn’t just about meeting regulations — it’s about building trust, reliability, and quality into every process. Learn more in Arbour Group’s latest post 👇 🔗 https://lnkd.in/ej_qewep #21CFRPart11 #Compliance #Validation #LifeSciences

Is your system really 21 CFR Part 11 compliant? Validating computerized systems is essential for regulated industries like pharma, biotech, and medical devices. It ensures electronic records and signatures are secure, traceable, and FDA-ready. ✅ Key focus areas: -Clear Validation Plan and documented IQ/OQ/PQ testing -Strong audit trails, access controls, and training -Continuous lifecycle management to maintain compliance Proper validation isn’t just about meeting regulations — it’s about building trust, reliability, and quality into every process. Learn more in Arbour Group’s latest post 👇 🔗 https://lnkd.in/ej_qewep #21CFRPart11 #Compliance #Validation #LifeSciences

FDA Regulated Facilities - Pharma / Biotech In the fast-paced world of pharmaceuticals and biotechnology, ensuring data integrity isn't just best practice—it's a regulatory must. Enter 21 CFR Part 11, the FDA's gold standard for electronic records and signatures, designed to make your digital documentation as trustworthy and secure as paper trails. At M4 Knick, we're committed to simplifying compliance without compromising on precision. Our MemoSuite sensor management software is engineered with 21 CFR Part 11 compliance at its core, offering features like: Unalterable, encrypted data storage to protect electronic records from tampering. Password-protected, role-based user access for secure permissions and traceability. Automated calibration certificates that eliminate manual record-keeping, supporting audit trails and GMP standards. Seamless integration with our Memosens® digital sensors for pH, ORP, conductivity, dissolved oxygen, and more—enabling predictive maintenance, diagnostics, and calibration of up to 10 sensors simultaneously. Whether you're monitoring high-purity water systems or optimizing bioprocesses, M4 Knick's solutions help you maintain data integrity, reduce downtime, and stay ahead of FDA audits. Ready to elevate your analytics game? Let's connect—drop a comment or DM me to discuss how we can support your compliance needs! #21CFRPart11 #ProcessAnalytics #PharmaCompliance #M4Knick #DataIntegrity https://m4knick.com/

✔️ Understanding 21 CFR Part 11 – The Backbone of Electronic Data Integrity ➡️ In today’s digital pharma environment, paperless systems are everywhere but with automation comes accountability. That’s where 21 CFR Part 11 comes in. ✅ What is 21 CFR Part 11? It’s an FDA regulation that defines the criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records. ✅ Key Requirements: Access control – only authorized users can create or modify records. Audit trails – every change must be time-stamped and traceable. Electronic signatures – must be unique, secure, and verifiable. Data integrity – records must be accurate, complete, and protected from alteration. ✅ Why it matters: Ensures regulatory compliance in GxP systems. Builds trust in digital records and automation. Reduces paper dependency while maintaining data authenticity. 📌 21 CFR Part 11 isn’t just about software validation - it’s about maintaining data integrity, traceability, and trust in a digital pharma world, medical devices, and food products.

Quality isn’t an after-thought. It’s how we build. At HiArc, quality assurance and regulatory compliance are foundational – embedded from the first sketch through to full production. Here’s how we live this: - We define regulatory and quality requirements at concept, so design, engineering and manufacturing move in lockstep. - Our Quality Management System (QMS) is ISO 13485:2016 certified and built around detailed documentation, automated alerts, and traceable systems – giving you audit-ready clarity from day one. - With certifications covering ISO 13485, IEC 62304, FDA QSR Parts 820/803/806, cGMP, and more, we uphold a spotless compliance track record across class I, II and III medical devices. - From subassemblies to full system integration, our quality mindset ensures that when you reach the market, the system performs exactly as intended: safely, reliably, and in full regulatory alignment. In diagnostics and life-science instruments, quality isn’t optional, it’s mission-critical. When every unit, measurement and output matters, we make sure you’re ready, not just for launch, but for life. 🔗Find out more: https://hubs.ly/Q03Qf1KQ0 #QualityAssurance #MedTech #Diagnostics

As before. But even more compliant. Missing documentation proof? Here’s the remedy! The new MAS-100 Sirius delivers a tamper-evident audit trail, 21 CFR Part 11-compliant user management as well as the option to scan the sampling environment. On top of the basics it ensures an error-free, wireless data transfer to your LIMS or EM software and transparent tracking of every sampling error. MAS-100 Sirius®. For serious air sampling. #AirSampling #Pharma #Cleanroom #QualityControl #MAS100Sirius

Recently, the FDA issued a warning letter to a small OTC drug manufacturer. The violations weren't exotic. Shared admin passwords. Skipped stability testing. Undocumented batch rework. But here's what matters: These are not isolated mistakes. They're systematic patterns. The lab software had a single admin account with shared passwords. When four assay tests failed, they accepted the fifth passing result. No investigation. The FDA's response? "Systemic quality unit failure." Five compliance red flags revealed: → Admin-by-default configurations  → Test-into-compliance patterns  → Formulation changes without revalidation  → Paused stability programs  → Rework without protocols The lesson: Modern GMP software should make these violations structurally impossible - not just traceable. When Electronic Batch Records and validated systems enforce SOPs automatically, compliance becomes engineering, not enforcement. Is your quality system preventing these patterns, or just documenting them after they happen?

Regulatory1 Consulting is a specialized regulatory consulting firm providing comprehensive support for product development, QMS documentation, and certification for medical device and IVD companies. Our services are designed to help clients achieve compliance with global regulatory standards efficiently and effectively. For this engagement, we supported our client—a medical device software company—throughout their certification audit process. Our team provided end-to-end assistance, including preparation of QMS documentation, gap assessment, audit readiness training, and on-site audit support. As a result of our collaborative efforts, the company successfully completed the certification audit with no major non-conformities (NCs). The auditors appreciated the robust QMS implementation, well-maintained documentation, and strong understanding of regulatory requirements. This outcome reflects both the client’s commitment to quality and the effectiveness of Regulatory1 Consulting’s structured approach to compliance and certification success.

A robust medical device packaging validation plan begins with one essential foundation: a full critical attribute calibration of your packaging equipment. This isn’t just a technical step, it’s the bedrock of sterile assurance and regulatory compliance. At Van der Stähl Scientific, our ISO 17025-accredited calibration laboratory delivers precise, traceable calibrations across all key parameters: temperature, time, rotational speed, and force. These attributes directly impact seal integrity and sterile barrier performance, making their accuracy non-negotiable in any validation strategy. With nearly 30 years of dedicated service to the medical device packaging industry, Van der Stähl Scientific has become a trusted partner for manufacturers worldwide. Our deep expertise, specialized equipment, and commitment to patient safety allow you to build a packaging program that’s not only compliant—but confidently repeatable. Leverage our capabilities to strengthen your validation, protect your product, and uphold the highest standards of sterile packaging. We’re here to help you calibrate with precision and package with purpose.

A robust medical device packaging validation plan begins with one essential foundation: a full critical attribute calibration of your packaging equipment. This isn’t just a technical step, it’s the bedrock of sterile assurance and regulatory compliance. At Van der Stähl Scientific, our ISO 17025-accredited calibration laboratory delivers precise, traceable calibrations across all key parameters: temperature, time, rotational speed, and force. These attributes directly impact seal integrity and sterile barrier performance, making their accuracy non-negotiable in any validation strategy. With nearly 30 years of dedicated service to the medical device packaging industry, Van der Stähl Scientific has become a trusted partner for manufacturers worldwide. Our deep expertise, specialized equipment, and commitment to patient safety allow you to build a packaging program that’s not only compliant—but confidently repeatable. Leverage our capabilities to strengthen your validation, protect your product, and uphold the highest standards of sterile packaging. We’re here to help you calibrate with precision and package with purpose.