SOP's are commonly confused with Electronic Batch Record work instructions; the difference is important; and they can work together to provide robust, compliant documentation that can differentiate a regulated product
The document contains questions related to personal information such as name, age, address, marital status and job. It also includes questions about introducing oneself, shopping, asking something specific, asking for opinions and making suggestions. Common questions involve asking what, where, when, how, who and asking if something is possible, available or liked.
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Đồ án Tổng hợp hệ thống truyền động điệnEvans Schoen
-Sử dụng động cơ điện một chiều kích từ độc lập điều khiển tốc độ của tải
theo yêu cầu về tốc độ như Hình 2.
-Nguồn điện sử dụng : 220/380V, do đó cần sử dụng bộ biến đổi phù hợp.
-Hệ thống hoạt động ổn định, bám càng sát với đồ thị tốc độ mong muốn thì càng tốt.
-Sai số nằm trong khoảng cho phép.
-Điều khiển động cơ dễ dàng, điều khiển động cơ có đảo chiều quay.
https://lop2.net/
Nhận viết luận văn đại học, thạc sĩ trọn gói, chất lượng, LH ZALO=>0909232620
Tham khảo dịch vụ, bảng giá tại: https://vietbaitotnghiep.com/dich-vu-viet-thue-luan-van
Download luận văn đồ án tốt nghiệp ngành điện công nghiệp với đề tài: Nghiên cứu tổng quan về hệ thống băng tải, thiết kế mô hình phân loại sản phẩm theo chiều cao dùng PLC
Nhận viết luận văn đại học, thạc sĩ trọn gói, chất lượng, LH ZALO=>0909232620
Tham khảo dịch vụ, bảng giá tại: https://vietbaitotnghiep.com/dich-vu-viet-thue-luan-van
Download luận văn đồ án tốt nghiệp ngành điện tử truyền thông với đề tài: Thiết kế và thi công máy in nhiệt cầm tay, cho các bạn làm luận văn tham khảo
The document contains questions related to personal information such as name, age, address, marital status and job. It also includes questions about introducing oneself, shopping, asking something specific, asking for opinions and making suggestions. Common questions involve asking what, where, when, how, who and asking if something is possible, available or liked.
Nhận viết luận văn đại học, thạc sĩ trọn gói, chất lượng, LH ZALO=>0909232620
Tham khảo dịch vụ, bảng giá tại: https://vietbaitotnghiep.com/dich-vu-viet-thue-luan-van
Download luận văn đồ án tốt nghiệp ngành điện tử truyền thông với đề tài: Thiết kế và thi công mạch điều khiển tốc độ động cơ DC sử dụng thuật toán Pid, cho các bạn làm luận văn tham khảo
Đồ án Tổng hợp hệ thống truyền động điệnEvans Schoen
-Sử dụng động cơ điện một chiều kích từ độc lập điều khiển tốc độ của tải
theo yêu cầu về tốc độ như Hình 2.
-Nguồn điện sử dụng : 220/380V, do đó cần sử dụng bộ biến đổi phù hợp.
-Hệ thống hoạt động ổn định, bám càng sát với đồ thị tốc độ mong muốn thì càng tốt.
-Sai số nằm trong khoảng cho phép.
-Điều khiển động cơ dễ dàng, điều khiển động cơ có đảo chiều quay.
https://lop2.net/
Nhận viết luận văn đại học, thạc sĩ trọn gói, chất lượng, LH ZALO=>0909232620
Tham khảo dịch vụ, bảng giá tại: https://vietbaitotnghiep.com/dich-vu-viet-thue-luan-van
Download luận văn đồ án tốt nghiệp ngành điện công nghiệp với đề tài: Nghiên cứu tổng quan về hệ thống băng tải, thiết kế mô hình phân loại sản phẩm theo chiều cao dùng PLC
Nhận viết luận văn đại học, thạc sĩ trọn gói, chất lượng, LH ZALO=>0909232620
Tham khảo dịch vụ, bảng giá tại: https://vietbaitotnghiep.com/dich-vu-viet-thue-luan-van
Download luận văn đồ án tốt nghiệp ngành điện tử truyền thông với đề tài: Thiết kế và thi công máy in nhiệt cầm tay, cho các bạn làm luận văn tham khảo
Nhận viết luận văn Đại học , thạc sĩ - Zalo: 0917.193.864
Tham khảo bảng giá dịch vụ viết bài tại: vietbaocaothuctap.net
Download luận văn tốt nghiệp ngành điện công nghiệp với đề tài: Thiết kế và xây dựng mô hình PLC điều khiển cho 5 quạt thông gió cho hệ thống nhà xưởng, cho các bạn tham khảo
These terms are often confused; they have important separate functions, and can work together to support regulated industry products with accurate and compliant documentation.
Basics of EBR: What Are Electronic Batch Records?Laura Olson
Software applications the store and manage data electronically for each batch produced in addition to the entire manufacturing process on a step-by-step basis.
EBR software typically relies on another system such as a manufacturing execution system or enterprise resource planning system to systematically generate a formal master batch record or EBR. This master record stores all the materials, processes and activities which were required for the production of a given product.
Electronic batch records provide the structure and means for automatically compiling batch production data into a formatted electronic document, reducing paper and manual records for more accurate record keeping.
Data is recorded and stored in encrypted form, guaranteeing data privacy and security.
This document provides a checklist for compliance with 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It discusses the need for validation, audit trails, electronic signatures, copies of records, and record retention. Each section provides points to evaluate like ensuring limited system access, time-stamped audit trails, unique electronic signatures, and the ability to produce accurate copies of electronic records. The document aims to help organizations evaluate their systems and processes to ensure compliance with FDA regulations for electronic records.
Epitome Technologies provides compliance solutions and computer system validation services to the life sciences industry. It has over a decade of experience in this field and clients across India and other regions. The company is located in Western India and is headed by experienced professionals including engineers and pharmacists. Epitome helps clients with initial validation of computer systems as well as ongoing maintenance and periodic reviews to ensure compliance with regulations from agencies such as US FDA, EU, and others. Its services include validation documentation, testing, and ensuring computer systems meet quality standards and regulatory requirements for electronic records over the lifetime of the systems.
Software configuration management (SCM) involves identifying and controlling changes to software components, and maintaining the integrity and traceability of changes throughout the software development life cycle. Key aspects of SCM include change control processes, version control, configuration auditing, and reporting. SCM helps manage the inevitable changes to software by establishing procedures for approving changes, checking components in and out for modification, testing and auditing changes, and communicating changes to relevant stakeholders.
Providing SharePoint Solutions in an FDA Regulated EnvironmentDeb Walther
This document discusses providing SharePoint solutions in a regulated FDA environment. It provides background on the FDA and drug approval process. It explains that computer systems used for clinical trials and drug development must be validated per 21 CFR Part 11. SharePoint can be used, but requires configuration in a separate isolated environment, change control, and validation documentation to ensure it meets regulatory requirements as an electronic records system. Documentation of installation, testing, and ongoing system management is necessary to comply with FDA regulations.
This document discusses electronic batch records (EBRs) and their role in creating a fully digital pharmaceutical manufacturing environment that complies with regulations. It explains that batch manufacturing records (BMRs) have traditionally documented pharmaceutical production batches but that EBRs are now replacing manual records. EBRs can be generated directly from manufacturing equipment and help automate documentation, remove errors, and improve consistency while ensuring compliance with data integrity standards for electronic records.
Data Integrity II - Chromatography data system (CDS) in PharmaSathish Vemula
- Introduction
- Functions of CDS
- Validation of CDS
- Regulatory requirements
- Procedures required
- Areas for ensuring CDS Data Integrity
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to CDS
- EU – Non compliance Reports
- WHO - Notice of Concern
- How to avoid observations ?
- Conclusion
This document discusses requirements change management. It begins with an introduction stating that requirements often change before a system is deployed, and that changes should be formally documented and controlled. It then describes the requirements change management process, including recording change proposals, analyzing impacts, deciding on changes, and implementing approved changes. It also discusses the importance of requirements traceability. Finally, it concludes that systematic change management helps ensure useful and successful system development.
Integrating and appling tmf regulation into your buisness processMontrium
How will you navigate the new TMF regulatory landscape?
Many organizations today still struggle to develop effective compliance strategies. In recent years we have seen a dramatic change in pace from regulatory authorities and standards organizations. With a wealth of new updates coming in, it is becoming increasingly more complex to remain compliant. With this in mind, our upcoming webinar will focus on the recent regulatory changes that will impact trial master files and provide a practical outlook on how to apply them and stay one step ahead.
Instant GMP Compliance Series -Better Compliance through Master Manufacturing...InstantGMP™
FDA inspections are increasing every year and they have published the results on their website. 50% of dietary supplement manufacturers are not in GMP compliance and 1 in 4 dietary supplement companies have received a warning letter which could result in a significant enforcement action such as halting production and distribution. Many of these producers received citation because they were not using Master Manufacturing Records.
Today’s manufacturers must proactively collaborate with their supply chains in order to manage production quality. At the same time, they need to stay compliant with ever-changing industry-, country- and customer-specific regulations.
You will learn:
- Top tips to manage quality across supply chains
- Proven methods to stay compliant in a global marketplace
- Why cloud-based Enterprise Resource Planning (ERP) and Enterprise Quality Management (EQM) are the keys to success
The document provides an overview of the CBER lot release system. It discusses how the CBER Office of Compliance and Biologics Quality is responsible for receiving, processing, and releasing product lots using the lot release system. It explains the lot release process, what products are covered, how it works at different stages such as for routine lot release of approved products and for products submitted in applications or supplements. It discusses regulations around lot release, alternatives to lot release such as placing products on surveillance, and future directions for the lot release system.
Validating SharePoint for Regulated Life Sciences ApplicationsMontrium
Validating SharePoint for Regulated Life Sciences Applications
Presented by Paul Fenton, CEO & President, Montrium
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
Nhận viết luận văn Đại học , thạc sĩ - Zalo: 0917.193.864
Tham khảo bảng giá dịch vụ viết bài tại: vietbaocaothuctap.net
Download luận văn tốt nghiệp ngành điện công nghiệp với đề tài: Thiết kế và xây dựng mô hình PLC điều khiển cho 5 quạt thông gió cho hệ thống nhà xưởng, cho các bạn tham khảo
These terms are often confused; they have important separate functions, and can work together to support regulated industry products with accurate and compliant documentation.
Basics of EBR: What Are Electronic Batch Records?Laura Olson
Software applications the store and manage data electronically for each batch produced in addition to the entire manufacturing process on a step-by-step basis.
EBR software typically relies on another system such as a manufacturing execution system or enterprise resource planning system to systematically generate a formal master batch record or EBR. This master record stores all the materials, processes and activities which were required for the production of a given product.
Electronic batch records provide the structure and means for automatically compiling batch production data into a formatted electronic document, reducing paper and manual records for more accurate record keeping.
Data is recorded and stored in encrypted form, guaranteeing data privacy and security.
This document provides a checklist for compliance with 21 CFR Part 11, which establishes criteria for electronic records and electronic signatures. It discusses the need for validation, audit trails, electronic signatures, copies of records, and record retention. Each section provides points to evaluate like ensuring limited system access, time-stamped audit trails, unique electronic signatures, and the ability to produce accurate copies of electronic records. The document aims to help organizations evaluate their systems and processes to ensure compliance with FDA regulations for electronic records.
Epitome Technologies provides compliance solutions and computer system validation services to the life sciences industry. It has over a decade of experience in this field and clients across India and other regions. The company is located in Western India and is headed by experienced professionals including engineers and pharmacists. Epitome helps clients with initial validation of computer systems as well as ongoing maintenance and periodic reviews to ensure compliance with regulations from agencies such as US FDA, EU, and others. Its services include validation documentation, testing, and ensuring computer systems meet quality standards and regulatory requirements for electronic records over the lifetime of the systems.
Software configuration management (SCM) involves identifying and controlling changes to software components, and maintaining the integrity and traceability of changes throughout the software development life cycle. Key aspects of SCM include change control processes, version control, configuration auditing, and reporting. SCM helps manage the inevitable changes to software by establishing procedures for approving changes, checking components in and out for modification, testing and auditing changes, and communicating changes to relevant stakeholders.
Providing SharePoint Solutions in an FDA Regulated EnvironmentDeb Walther
This document discusses providing SharePoint solutions in a regulated FDA environment. It provides background on the FDA and drug approval process. It explains that computer systems used for clinical trials and drug development must be validated per 21 CFR Part 11. SharePoint can be used, but requires configuration in a separate isolated environment, change control, and validation documentation to ensure it meets regulatory requirements as an electronic records system. Documentation of installation, testing, and ongoing system management is necessary to comply with FDA regulations.
This document discusses electronic batch records (EBRs) and their role in creating a fully digital pharmaceutical manufacturing environment that complies with regulations. It explains that batch manufacturing records (BMRs) have traditionally documented pharmaceutical production batches but that EBRs are now replacing manual records. EBRs can be generated directly from manufacturing equipment and help automate documentation, remove errors, and improve consistency while ensuring compliance with data integrity standards for electronic records.
Data Integrity II - Chromatography data system (CDS) in PharmaSathish Vemula
- Introduction
- Functions of CDS
- Validation of CDS
- Regulatory requirements
- Procedures required
- Areas for ensuring CDS Data Integrity
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to CDS
- EU – Non compliance Reports
- WHO - Notice of Concern
- How to avoid observations ?
- Conclusion
This document discusses requirements change management. It begins with an introduction stating that requirements often change before a system is deployed, and that changes should be formally documented and controlled. It then describes the requirements change management process, including recording change proposals, analyzing impacts, deciding on changes, and implementing approved changes. It also discusses the importance of requirements traceability. Finally, it concludes that systematic change management helps ensure useful and successful system development.
Integrating and appling tmf regulation into your buisness processMontrium
How will you navigate the new TMF regulatory landscape?
Many organizations today still struggle to develop effective compliance strategies. In recent years we have seen a dramatic change in pace from regulatory authorities and standards organizations. With a wealth of new updates coming in, it is becoming increasingly more complex to remain compliant. With this in mind, our upcoming webinar will focus on the recent regulatory changes that will impact trial master files and provide a practical outlook on how to apply them and stay one step ahead.
Instant GMP Compliance Series -Better Compliance through Master Manufacturing...InstantGMP™
FDA inspections are increasing every year and they have published the results on their website. 50% of dietary supplement manufacturers are not in GMP compliance and 1 in 4 dietary supplement companies have received a warning letter which could result in a significant enforcement action such as halting production and distribution. Many of these producers received citation because they were not using Master Manufacturing Records.
Today’s manufacturers must proactively collaborate with their supply chains in order to manage production quality. At the same time, they need to stay compliant with ever-changing industry-, country- and customer-specific regulations.
You will learn:
- Top tips to manage quality across supply chains
- Proven methods to stay compliant in a global marketplace
- Why cloud-based Enterprise Resource Planning (ERP) and Enterprise Quality Management (EQM) are the keys to success
The document provides an overview of the CBER lot release system. It discusses how the CBER Office of Compliance and Biologics Quality is responsible for receiving, processing, and releasing product lots using the lot release system. It explains the lot release process, what products are covered, how it works at different stages such as for routine lot release of approved products and for products submitted in applications or supplements. It discusses regulations around lot release, alternatives to lot release such as placing products on surveillance, and future directions for the lot release system.
Validating SharePoint for Regulated Life Sciences ApplicationsMontrium
Validating SharePoint for Regulated Life Sciences Applications
Presented by Paul Fenton, CEO & President, Montrium
For more information on Montrium please visit:
- www.montrium.com
- www.twitter.com/Montrium
- www.youtube.com/Montrium
or email info@montrium.com
Webinar on Environmental Footprint Screening studyMarisa Vieira
This slides deck includes the materials used in the webinar we hosted on the screening study for the Environmental Footprint pilot phase. We gave this webinar on behalf of the Environmental Footprint team from the European Commission.
Gain the latest insight (2013) into 21 CFR Part 11 Compliance from AITalent's latest Webinar.
Discover:
Part 11 – What it is not, the myths.
Part 11 – What it is, the facts.
Part 11 – What does the future hold?
Find out more: www.aitalent.co.uk
Requirements management is the process of managing changes to system requirements. This lecture discusses reasons for changing requirements and how to manage them. Requirements cannot be effectively managed without traceability between requirements and other project artifacts. Requirements will inevitably change for reasons like evolving stakeholder needs, environmental changes, and technical issues. There are both stable and volatile requirements, with volatile types including mutable, emergent, consequential, and compatibility requirements.
Software systems require ongoing maintenance to remain useful as their environments change. There are four main types of maintenance: corrective, adaptive, perfective, and preventative. Configuration management is important for tracking changes made during maintenance to ensure quality. It involves identifying software components, controlling different versions, approving changes, auditing changes, and reporting on changes. Maintaining software can be challenging due to various technical and organizational factors.
Similar to SOP's vs manufacturing instructions (20)
8 Best Automated Android App Testing Tool and Framework in 2024.pdfkalichargn70th171
Regarding mobile operating systems, two major players dominate our thoughts: Android and iPhone. With Android leading the market, software development companies are focused on delivering apps compatible with this OS. Ensuring an app's functionality across various Android devices, OS versions, and hardware specifications is critical, making Android app testing essential.
🏎️Tech Transformation: DevOps Insights from the Experts 👩💻campbellclarkson
Connect with fellow Trailblazers, learn from industry experts Glenda Thomson (Salesforce, Principal Technical Architect) and Will Dinn (Judo Bank, Salesforce Development Lead), and discover how to harness DevOps tools with Salesforce.
Superpower Your Apache Kafka Applications Development with Complementary Open...Paul Brebner
Kafka Summit talk (Bangalore, India, May 2, 2024, https://events.bizzabo.com/573863/agenda/session/1300469 )
Many Apache Kafka use cases take advantage of Kafka’s ability to integrate multiple heterogeneous systems for stream processing and real-time machine learning scenarios. But Kafka also exists in a rich ecosystem of related but complementary stream processing technologies and tools, particularly from the open-source community. In this talk, we’ll take you on a tour of a selection of complementary tools that can make Kafka even more powerful. We’ll focus on tools for stream processing and querying, streaming machine learning, stream visibility and observation, stream meta-data, stream visualisation, stream development including testing and the use of Generative AI and LLMs, and stream performance and scalability. By the end you will have a good idea of the types of Kafka “superhero” tools that exist, which are my favourites (and what superpowers they have), and how they combine to save your Kafka applications development universe from swamploads of data stagnation monsters!
Odoo releases a new update every year. The latest version, Odoo 17, came out in October 2023. It brought many improvements to the user interface and user experience, along with new features in modules like accounting, marketing, manufacturing, websites, and more.
The Odoo 17 update has been a hot topic among startups, mid-sized businesses, large enterprises, and Odoo developers aiming to grow their businesses. Since it is now already the first quarter of 2024, you must have a clear idea of what Odoo 17 entails and what it can offer your business if you are still not aware of it.
This blog covers the features and functionalities. Explore the entire blog and get in touch with expert Odoo ERP consultants to leverage Odoo 17 and its features for your business too.
An Overview of Odoo ERP
Odoo ERP was first released as OpenERP software in February 2005. It is a suite of business applications used for ERP, CRM, eCommerce, websites, and project management. Ten years ago, the Odoo Enterprise edition was launched to help fund the Odoo Community version.
When you compare Odoo Community and Enterprise, the Enterprise edition offers exclusive features like mobile app access, Odoo Studio customisation, Odoo hosting, and unlimited functional support.
Today, Odoo is a well-known name used by companies of all sizes across various industries, including manufacturing, retail, accounting, marketing, healthcare, IT consulting, and R&D.
The latest version, Odoo 17, has been available since October 2023. Key highlights of this update include:
Enhanced user experience with improvements to the command bar, faster backend page loading, and multiple dashboard views.
Instant report generation, credit limit alerts for sales and invoices, separate OCR settings for invoice creation, and an auto-complete feature for forms in the accounting module.
Improved image handling and global attribute changes for mailing lists in email marketing.
A default auto-signature option and a refuse-to-sign option in HR modules.
Options to divide and merge manufacturing orders, track the status of manufacturing orders, and more in the MRP module.
Dark mode in Odoo 17.
Now that the Odoo 17 announcement is official, let’s look at what’s new in Odoo 17!
What is Odoo ERP 17?
Odoo 17 is the latest version of one of the world’s leading open-source enterprise ERPs. This version has come up with significant improvements explained here in this blog. Also, this new version aims to introduce features that enhance time-saving, efficiency, and productivity for users across various organisations.
Odoo 17, released at the Odoo Experience 2023, brought notable improvements to the user interface and added new functionalities with enhancements in performance, accessibility, data analysis, and management, further expanding its reach in the market.
Manyata Tech Park Bangalore_ Infrastructure, Facilities and Morenarinav14
Located in the bustling city of Bangalore, Manyata Tech Park stands as one of India’s largest and most prominent tech parks, playing a pivotal role in shaping the city’s reputation as the Silicon Valley of India. Established to cater to the burgeoning IT and technology sectors
Everything You Need to Know About X-Sign: The eSign Functionality of XfilesPr...XfilesPro
Wondering how X-Sign gained popularity in a quick time span? This eSign functionality of XfilesPro DocuPrime has many advancements to offer for Salesforce users. Explore them now!
Alluxio Webinar | 10x Faster Trino Queries on Your Data PlatformAlluxio, Inc.
Alluxio Webinar
June. 18, 2024
For more Alluxio Events: https://www.alluxio.io/events/
Speaker:
- Jianjian Xie (Staff Software Engineer, Alluxio)
As Trino users increasingly rely on cloud object storage for retrieving data, speed and cloud cost have become major challenges. The separation of compute and storage creates latency challenges when querying datasets; scanning data between storage and compute tiers becomes I/O bound. On the other hand, cloud API costs related to GET/LIST operations and cross-region data transfer add up quickly.
The newly introduced Trino file system cache by Alluxio aims to overcome the above challenges. In this session, Jianjian will dive into Trino data caching strategies, the latest test results, and discuss the multi-level caching architecture. This architecture makes Trino 10x faster for data lakes of any scale, from GB to EB.
What you will learn:
- Challenges relating to the speed and costs of running Trino in the cloud
- The new Trino file system cache feature overview, including the latest development status and test results
- A multi-level cache framework for maximized speed, including Trino file system cache and Alluxio distributed cache
- Real-world cases, including a large online payment firm and a top ridesharing company
- The future roadmap of Trino file system cache and Trino-Alluxio integration
DECODING JAVA THREAD DUMPS: MASTER THE ART OF ANALYSISTier1 app
Are you ready to unlock the secrets hidden within Java thread dumps? Join us for a hands-on session where we'll delve into effective troubleshooting patterns to swiftly identify the root causes of production problems. Discover the right tools, techniques, and best practices while exploring *real-world case studies of major outages* in Fortune 500 enterprises. Engage in interactive lab exercises where you'll have the opportunity to troubleshoot thread dumps and uncover performance issues firsthand. Join us and become a master of Java thread dump analysis!
WWDC 2024 Keynote Review: For CocoaCoders AustinPatrick Weigel
Overview of WWDC 2024 Keynote Address.
Covers: Apple Intelligence, iOS18, macOS Sequoia, iPadOS, watchOS, visionOS, and Apple TV+.
Understandable dialogue on Apple TV+
On-device app controlling AI.
Access to ChatGPT with a guest appearance by Chief Data Thief Sam Altman!
App Locking! iPhone Mirroring! And a Calculator!!
Liberarsi dai framework con i Web Component.pptxMassimo Artizzu
In Italian
Presentazione sulle feature e l'utilizzo dei Web Component nell sviluppo di pagine e applicazioni web. Racconto delle ragioni storiche dell'avvento dei Web Component. Evidenziazione dei vantaggi e delle sfide poste, indicazione delle best practices, con particolare accento sulla possibilità di usare web component per facilitare la migrazione delle proprie applicazioni verso nuovi stack tecnologici.
Consistent toolbox talks are critical for maintaining workplace safety, as they provide regular opportunities to address specific hazards and reinforce safe practices.
These brief, focused sessions ensure that safety is a continual conversation rather than a one-time event, which helps keep safety protocols fresh in employees' minds. Studies have shown that shorter, more frequent training sessions are more effective for retention and behavior change compared to longer, infrequent sessions.
Engaging workers regularly, toolbox talks promote a culture of safety, empower employees to voice concerns, and ultimately reduce the likelihood of accidents and injuries on site.
The traditional method of conducting safety talks with paper documents and lengthy meetings is not only time-consuming but also less effective. Manual tracking of attendance and compliance is prone to errors and inconsistencies, leading to gaps in safety communication and potential non-compliance with OSHA regulations. Switching to a digital solution like Safelyio offers significant advantages.
Safelyio automates the delivery and documentation of safety talks, ensuring consistency and accessibility. The microlearning approach breaks down complex safety protocols into manageable, bite-sized pieces, making it easier for employees to absorb and retain information.
This method minimizes disruptions to work schedules, eliminates the hassle of paperwork, and ensures that all safety communications are tracked and recorded accurately. Ultimately, using a digital platform like Safelyio enhances engagement, compliance, and overall safety performance on site. https://safelyio.com/
Malibou Pitch Deck For Its €3M Seed Roundsjcobrien
French start-up Malibou raised a €3 million Seed Round to develop its payroll and human resources
management platform for VSEs and SMEs. The financing round was led by investors Breega, Y Combinator, and FCVC.
2. SOP’s and EBR’s are often confused
• Per ICH(International Council on Harmonization), an SOP is a detailed,
written instruction to achieve uniformity of the performance of a
specific function. They are informed by the mandating guidelines of
regulatory entities.
• Electronic Batch Records provide the structure and means for
automatically compiling batch production data into an electronic
format.
• Most of the confusion comes from those entering regulated domains
for the first time, or within domains where the regulations are in the
process of completion
3. FDA, CDPH, etc. require SOPs for
Compliance
• Define requirements as
referenced by regulatory
authority guidelines, e.g.,
21 CFR Part 111.15 for
sanitation of physical plant
and grounds
• Should be available and
complete for regulatory
audits, etc.
• Should be read,
understood, and followed
by all applicable company
roles
4. SOP’s differ from EBR
Manufacturing Instructions
• SOP = regulatory directive for uniformity
• Manufacturing Instructions = process steps
in an Electronic Batch Record that transitions
(creates, extracts, packages, etc. ) a product
• Manufacturing instructions must follow
applicable SOP’s
5. SOP’s are especially effective when linked into
Electronic Batch Records
SOP-EBR LINKAGE BENEFITS
• Operations teams can easily check for
required action steps to complete during
real time production
• Production documentation clearly
illustrates connection to the regulatory
”mother lode” for an auditing entity,
customer, prospective contract agreement,
etc.
7. SOP’s and Electronic Batch Records work
together; both need direction and care
• Worksteps should be aligned to the guidelines when creating
production procedures in a Master Production Record
• Additions and revisions for your SOP’s and EBR’s should be tracked
• Batch record and SOP training for your teams should be recorded and
kept up to date.
• Timely ‘review and revise’ sessions can prove helpful if SOP’s and
EBR’s are configurable.
Editor's Notes
The staff at InstantGMP prepared the GMP for Dietary Supplements Compliance Series of presentations to focus on good manufacturing practices and GMP compliance for dietary supplements manufacturing. These are brought to you by our quality and manufacturing experts in the hope that it will help you avoid any GMP compliance issues in your shop. This presentation will address the flow of GMP processes.
Implementing a quality system for Good Manufacturing Practices is required by the FDA. Their regulations are written in very general terms so they have to interpreted for each type of manufacturing operation. The interpretation shows up in the policies and standard operating procedures that are written by or for the manufacturing company. The electronic batch record software and SOPs from InstantGMP provide the foundation for a total quality system.