“Failure to follow established SOPs is one of the most frequently cited violations in FDA 483s and warning letters. The frequency of SOP-related violations points to the need for all regulated companies to review their SOPs, their methods for distributing compliant SOP training curricula, their methods of validating receipt and testing for comprehension of the materials, and their documentation of SOP training activities. Additionally, enterprise-wide training programs must include automated methods for new employee on boarding, and for annual refresher training. “
BioPharm International
Global Quality Assurance and Regulatory Compliance
by Denise Queffelec and David Peterson
The NextDocs' pre configured solution for managing procedural documentation addresses these key challenges to deliver a compliant, user-friendly solution while minimizing the demands on your already overtaxed business and IT users.
The Legislative Compliance Management Solution (LCMS) is a centralized and automated tool designed to empower organizations to easily track and achieve regulatory compliance.
A Service designed to provide IT Departments with an understanding of the Application Compatibility and Remediation needs that their organization faces prior to the Client Migration along with a Discovery of their Environment
The Legislative Compliance Management Solution (LCMS) is a centralized and automated tool designed to empower organizations to easily track and achieve regulatory compliance.
A Service designed to provide IT Departments with an understanding of the Application Compatibility and Remediation needs that their organization faces prior to the Client Migration along with a Discovery of their Environment
Utilizing a unique client centric environment ARMnet allows institutions to manage loan or Mortgage products for special servicing or collections in an intuitive environment. All loan management functionality in the life cycle of the loan can be easily viewed here.
EaZe-PDMS is a web based system with repository to have all the documents and drawings stored logically and have access rights based on the privilege each user has. The System has all the below features which will address the challenges faced in the manual product data management, moreover increase the productivity and enhance the efficiency. The system will also help to meet the compliance for ISO & AS certification.
Best Practices for Integrating Applications DevelopmentKovair
Enterprise application integration remains an age-old challenge. If done properly with the right choice of technology and best practice considerations, Application integration can deliver immense strategic and technical value. How enterprises pursue application integration can make the difference between pitfalls and positive possibilities.
A Refreshing Start Pre-Issue Documentation, Best's Review, December 2008Gates Ouimette
#Scanning as part of the overall #lifeinsurance policy #workflow and process.
Pre-issue #process visioning, both strategic and tactical, is critical to the #policylifecycle.
The decision to invest in systems or #offshore resources ultimately should get evaluated within the context of current #businessprocesses.
Make the most of your SharePoint implementation by aligning the system architecture with your business goals.
Maximise the value you gain from your SharePoint solution
Identity and Request Management Using Novell Identity Manager: Identity Manag...Novell
To support regulatory compliance, audit requirements and its strategic direction, St. Vincent Health joined with Novell to design, develop and implement a Novell Identity Manager system in its 18 hospitals to provide role-based access control and audit capabilities that exceed auditor requirements. This session will provide an overview of the business case, benefits, phased approach and technical solution for role-based access at St. Vincent Health in support of HIPAA compliance. This session will provide a demonstration of Novell Identity Manager based workflow customization, role-based access control entitlements and provisioning. It will also demonstrate how Identity Manager can be used to manage other processes other than identity and access management. You will see a complete demonstration of St. Vincent’s Identity Manager solution and how Novell Sentinel reporting is providing answers to auditor and management questions.
The NextDocs Qualty Management System consists of a variety of pre configured solutions for managing SOPs, deviations, complaints, audit findings, change control and CAPA to deliver compliant, user-friendly solutions while minimizing the demands on business and IT Users.
For more information visit http://www.nextdocs.com
Utilizing a unique client centric environment ARMnet allows institutions to manage loan or Mortgage products for special servicing or collections in an intuitive environment. All loan management functionality in the life cycle of the loan can be easily viewed here.
EaZe-PDMS is a web based system with repository to have all the documents and drawings stored logically and have access rights based on the privilege each user has. The System has all the below features which will address the challenges faced in the manual product data management, moreover increase the productivity and enhance the efficiency. The system will also help to meet the compliance for ISO & AS certification.
Best Practices for Integrating Applications DevelopmentKovair
Enterprise application integration remains an age-old challenge. If done properly with the right choice of technology and best practice considerations, Application integration can deliver immense strategic and technical value. How enterprises pursue application integration can make the difference between pitfalls and positive possibilities.
A Refreshing Start Pre-Issue Documentation, Best's Review, December 2008Gates Ouimette
#Scanning as part of the overall #lifeinsurance policy #workflow and process.
Pre-issue #process visioning, both strategic and tactical, is critical to the #policylifecycle.
The decision to invest in systems or #offshore resources ultimately should get evaluated within the context of current #businessprocesses.
Make the most of your SharePoint implementation by aligning the system architecture with your business goals.
Maximise the value you gain from your SharePoint solution
Identity and Request Management Using Novell Identity Manager: Identity Manag...Novell
To support regulatory compliance, audit requirements and its strategic direction, St. Vincent Health joined with Novell to design, develop and implement a Novell Identity Manager system in its 18 hospitals to provide role-based access control and audit capabilities that exceed auditor requirements. This session will provide an overview of the business case, benefits, phased approach and technical solution for role-based access at St. Vincent Health in support of HIPAA compliance. This session will provide a demonstration of Novell Identity Manager based workflow customization, role-based access control entitlements and provisioning. It will also demonstrate how Identity Manager can be used to manage other processes other than identity and access management. You will see a complete demonstration of St. Vincent’s Identity Manager solution and how Novell Sentinel reporting is providing answers to auditor and management questions.
The NextDocs Qualty Management System consists of a variety of pre configured solutions for managing SOPs, deviations, complaints, audit findings, change control and CAPA to deliver compliant, user-friendly solutions while minimizing the demands on business and IT Users.
For more information visit http://www.nextdocs.com
Find out more about Chronos Workflow Platform - self-service solution to automate business processes. If may should be interested in business process automation, workflow solutions to increase productivity, please contact us for a discussion. Chronos Workflow is available as Saas or in Enterprise edition. We have bluechip user references already in 11 countries so far. Feel free to check out our clients and solution on www.chronosworkflow.com
5 technologies that shorten the document lifecycle & increase productivityNikec Solutions
As the business world moves faster, lawyers are expected to respond to a client’s demand swiftly and consequently need to produce documents quicker than ever. With the different processes involved between the creation and the completion of a document (initial scanning, editing, reviewing, approval and sharing) – i.e. the document lifecycle – teams must stay sharp and consistent to meet those shorter response times.
Digitalisation has revolutionised the speed at which we work with documents but the use of latest technologies can further enhance this. Here are some of the instrumental technologies that will help optimise your document life cycle, without requiring an army of IT experts to manage.
Chronos Workflow - Business process automation without programmingEdith Varhelyi
Self-service business process automation solution for teams of 5-5000 users. No programming needed. Fortune 500 companies and SMEs are already using it in 15 countries.
NextDocs’ collaborative solution for clinical trials, built on Microsoft SharePoint provides an integrated platform that streamlines processes, automates information exchange, and dramatically reduces administrative overhead associated with running clinical trials. Our clinical portal allows clinical teams to work together in an effective and efficient manner by keeping trial personnel connected, informed and on task – providing access to everyone at any time, from anywhere. NextDocs Clinical Document Management solution is based on the NextDocs compliance platform, which includes a comprehensive set of features that address all ICH, FDA, EMEA, and MHLW regulatory requirements.
cP-DocRev is a priority web-based advanced linear discovery review and repository platform. built with best-in-breed technology the platform is customizable and scalable. Offers built-in analytics and fully integrated production capabilities developed on fully open end architecture.
Automating Patient Management with ApplicationXtender WorkflowChristopher Wynder
The hardest part about managing a clinic is keeping everybody up-to-date with the right information. Whether this is simply making sure billing is alerted of a new bill or as complex as managing follow-ups after a referral. There is simply too many documents, emails and schedules for a person to manage. This is the value of workflow to a clinic or hospital- setting the rules regarding who gets to see certain types of documents and ensuring that know about the updated information.
Document and workflow management solutions help eliminate the use of paper and provides a great way for businesses and governmental agencies streamline processes in the workplace.
OpenText ApplicationXtender provides cost effective document management. For software vendors looking to expand or build a healthcare focused product, "AX" can be embedded to provide first class content services in without the high cost of research and development.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
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Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
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2. Simple, Effective and Compliant SOP and Employee Training
Management through the Entire Lifecycle
“Failure to follow established SOPs is one of the most frequently cited violations in FDA 483s and warning letters. The
frequency of SOP-related violations points to the need for all regulated companies to review their SOPs, their methods
for distributing compliant SOP training curricula, their methods of validating receipt and testing for comprehension of
the materials, and their documentation of SOP training activities. Additionally, enterprise-wide training programs must
include automated methods for new employee on boarding, and for annual refresher training. “
BioPharm International
Global Quality Assurance and Regulatory Compliance
by Denise Queffelec and David Peterson
The NextDocs Solution Key Features and Benefits
Our pre configured solution for managing procedural documentation All the benefits of traditional
addresses these key challenges to deliver a compliant, user-friendly solution
while minimizing the demands on your already overtaxed business and IT document management
users. system plus more:
» Support for and enforcement
of your business processes
A FAMILIAR INTERFACE
Because NextDocs is built upon SharePoint, a technology that many
» Decreased time to review and
business users already use, training and ramp-up time are reduced. Most approve documents
companies already have the ability to support and administer SharePoint –
unlike highly specialized document management technologies where several » Significantly decreased
administrators must sometimes be hired just to support a single application. handling of paper
BUILT-IN COMPLIANCE » 21 CFR Part 11 compliance
For SOPs and related documents, the ability to comply with 21 CFR Part
11 is necessary in order to use electronic documents in place of paper » Streamlined validation,
assisted by our validation
documents. Part 11 also applies to electronic systems that generate, track
toolkit
and recall official paper copies.
» Streamlined deployment and
NextDocs supports both GxP and Part 11 compliance through the use of increased user acceptance
built-in and configurable business processes providing compliant procedures due to our familiar user
for review, approval, signature, effectivity, period review, change requests, interface
and user training and training records.
» Ability to provide user
interface in the local language
SCALABLE FOR THE ENTERPRISE
SharePoint has the proven ability to manage millions of documents over local
» Decreased cost of ownership
and wide area networks, providing users with the performance they expect. and accelerated return on
By using SharePoint, you eliminate the need to implement complicated IT investment
solutions if you expand to a new region or office.
3. CONFIGURED TO YOUR NEEDS
In recent years, the life sciences industry has learned through experience about the high cost of ownership associated
with custom solutions. Although NextDocs starts with an industry proven configuration, we understand that you may have
sound business reasons to expand the inventory of documents managed, implement variants on our standard review and
approval processes, or track special properties that provide valuable information to system users. In short, the software
should support your business processes, not the other way around. Almost all user requests can be accommodated by
simple system configurations, without requiring custom software development.
Sample View: NextDocs SOP and Employee Training Management System
SOP Solution Components
When you purchase the NextDocs Procedural Document Management solution, you start with a product that is
fully configured for use in managing SOPs, and which could be validated and deployed by doing nothing more than
adding specific information about your products, departments, etc. to pre-existing lists, importing your templates, and
adding your users to appropriate roles.
STANDARD SOLUTION COMPONENTS
» Preconfigured SOPs, Policies, Forms, Batch Records, Attachments, and Change Requests
» Predefined lists that limit valid values for document properties to values that you supply
» Creating of documents from your templates or by import from the file system
» Best practice lifecycle for review, approval, finalization, and revision with appropriate change requests
» Review and approval workflows
» Automatic or manual release for training and effectivity
» Change Request forms and processes designed to your requirements
» Role-based security
» Periodic review process
» Watermarks and overlays
» Controlled, uncontrolled and clean copy printing
4. NEXTDOCS COMPLIANCE PLATFORM
The NextDocs Compliance Platform includes a comprehensive set of features that addresses all ICH, FDA, EMEA, and MHLW
regulatory requirements. It is built in and fully integrated with the Microsoft SharePoint Server framework.
■ Real-time Adobe PDF conversion triggered by ■ Version tracking with major and minor versioning, version
document state change or workflow step history and previous version restoration
■ Controlled document management including ■ Configurable document numbering
configurable application of watermarks & overlays
■ Auto population of document properties
■ Full lifecycle management of the document from
inception to obsolescence ■ Electronic/digital signatures that address all regulatory
requirements
■ Flexible and powerful process automation tools for
change requests, document review, and approval ■ Audit trails that provide a detailed log of every activity
performed in the system
■ Check in/Check out controls to prevent documents
from being overwritten
NextDocs is the global leader in providing Microsoft SharePoint-based document and Main Headquarters EU Headquarters
quality management solutions to life sciences organizations. It enables businesses in 500 N. Gulph Road Elisabethstrasse 91,
regulated industries to achieve compliance with FDA and other agencies while automating Suite 240 80797 Munich
processes, improving efficiency and dramatically reducing costs. NextDocs customers King of Prussia, PA 19406 Germany
include Pharmaceutical companies, Bio-Techs, Medical Device companies and CROs. Tel: 610.265.9474 Tel: +49.89.5908.1435
For more Information visit www.nextdocs.com
Accredited by
ANAB