Deciphering CFR Part 11 for medical device companies seeking Quality Management System (EQMS). Vital considerations include software validation, audit trails, electronic signatures, record protection, and seamless integration. Unifize stands as a CFR Part 11-compliant solution, addressing each facet for enhanced credibility and regulatory adherence.

Before starting a software company, I used to run my own manufacturing plant making industrial enclosures for the power sector. My co-founder, Lakshman, ran a food processing unit making extruded snack pellets (🤷🏻‍♂️no idea what that means). We both faced the same problem – it used to take forever to get anything done. Especially in continuous improvement processes like CAPAs. If you study the process, you’ll understand why it’s so hard to get anything done.

In the competitive realm of automotive manufacturing, discover the pitfalls of relying on Microsoft SharePoint for Quality Management System (QMS). Unifize emerges as the dedicated solution, addressing customization challenges, ensuring seamless integration, and offering advanced features for compliance and supplier collaboration, outperforming SharePoint in automotive quality management.

For quality & operations leaders at manufacturing companies: How to implement software in less than a day AND save up to $185,000 in consulting fees, expensive customization, pointless training, financial risk, administrative overheads, and IT expenses (along with pain and suffering…)

Whether you're keen on future-proofing your quality management, exploring Lean & Six Sigma, or seeking process efficiency, this read is tailored for you. Trace the history of eQMS, uncover its enduring issues, and understand why traditional systems struggle with collaborative processes. Recognize signs of accountability, visibility, and efficiency challenges, and explore potential solutions, including integrating enterprise chat tools or embracing Collaborative Process Platforms for improved collaboration, accountability, and efficiency.

A study of 47 manufacturing plants found that 78% of quality events go unreported, hindering process improvement. Issues arise from digital system complexities, shop floor accessibility, misaligned goals, silos, and auditor pressures. Solutions include creating a second issue class, simplifying systems, promoting engagement, and aligning with auditors.

Learn how managers of product design or engineering teams at manufacturing companies can reduce cycle times by up to 75% in less than 30 days by implementing closed-loop, objective-driven conversations.

Learn how managers of sales teams at companies that manufacture customized products can enable remote work and increase accountability, improve visibility and boost overall efficiency by reducing unnecessary internal emails & meetings by up to 90%.