RCM Technologies (NASDAQ: RCMT) is a premier provider of business and technology solutions uniquely designed to enhance and maximize operational performance for over 35 years. RCM helped a Fortune 100 pharmaceutical company remediate its computer systems to comply with FDA consent decrees, assessing documentation, identifying issues, and validating a major system release with new processes. RCM experts completed the assessment ahead of schedule and under budget, and supported quality assurance initiatives through expertise, consistency, immediate productivity and cultural alignment.
https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...April Bright
Product launch is not the time to start securing reimbursement for your device. Reimbursement remains a complex process for orthopaedic companies that could be lessened if properly aligned throughout commercialization. Mr. Hunter shares the who, what and when of reimbursement to ensure that you’ve received proper coverage prior to launch.
PowerShell with SharePoint 2013 and Office 365 - EPC GroupEPC Group
PowerShell with SharePoint 2013 and Office 365
Web: www.epcgroup.net | E-mail: contact@epcgroup.net | Phone: (888) 381-9725 | Twitter: @epcgroup
* SharePoint Server 2013, Office 365, Windows Azure, Amazon Web Services (AWS), SharePoint Server 2010 & SharePoint 2007: Review, Architecture Development, Planning, Configuration & Implementations, Upgrades, Global Initiatives, Training, and Post Go-live Support with Extensive Knowledge Transfer | Custom Branding and Responsive Web Design (RWD)
* Health Check & Assessments (Roadmap Preparation to Upgrade to 2013 or 2010) - Including Custom Code & Solution Review
* Enterprise Content Management Systems based on Microsoft SharePoint 2013, Office 365 Hybrid Cloud (Both On-premises and cloud)
* Enterprise Metadata Design, Taxonomy | Retention Schedule Dev | Disposition Workflow, and Records Management | eDiscovery | Microsoft Exchange 2013 Migration \ Integration | Roadmap, Requirements Gathering, Planning, Designing & Performing the Actual Implementation
* Best Practices Consulting on SharePoint 2013, Office 365, SharePoint 2010, 2007 | EPC Group has completed over 900+ initiatives
* Intranet, Knowledge Management, Internet & Extranet-Facing as Well as Mobility (BYOD Roadmap), Cloud, Hybrid, and Cross-Browser | Cross-Platform Solutions for SharePoint 2013 with Proven Past-performance
*Upgrades or Migrations of Existing Deployments or Other LOB Systems (Documentum, LiveLink, FileNet, SAP, etc.)
* Custom Apps, Custom Application Development, Custom Feature, Master Pages, Web Parts, Security Model, Usability (UI) & Workflow Development (Visual Studio 2012, Visual Studio 2013)
* Migration Initiatives to SharePoint 2013 \ Office 365 and those organizations with both on-premises and cloud assets for a SharePoint Hybrid Architecture and Deployment
* Key Performance Indicators, Dashboard & Business Intelligence Reporting Solutions (PerformancePoint 2013, SQL Server 2012 R2, SQL Server 2014, BI, KPIs, PowerPivot, Scorecards, Big Data) and Power BI
* Experts in Global \ Enterprise Infrastructure, Security, Hardware Configuration & Disaster Recovery (Global performance considerations)
* Tailored SharePoint "in the trenches" Training on SharePoint 2013, 2010, 2007 + Office 365
* Support Contracts (Ongoing Support your Organization's 2013, 2010, or 2007 Implementations)
* .NET Development, Custom applications, BizTalk Server experts
* Project Server 2013, 2010, and 2007 Implementations
* SharePoint Roadmap & Governance Development: 6, 12, 18, 24 and 36 months (Steering Committee & Code Review Board Development)
https://quality.eqms.co.uk/blog/good-practice-in-the-pharmaceutical-industry
What is GxP? What is GxP important for the life science industry? How can you use software to comply with GxP
Good Practice in the Life Science industry
Plan for Success Strategies to Align Reimbursement and Commercialization - OM...April Bright
Product launch is not the time to start securing reimbursement for your device. Reimbursement remains a complex process for orthopaedic companies that could be lessened if properly aligned throughout commercialization. Mr. Hunter shares the who, what and when of reimbursement to ensure that you’ve received proper coverage prior to launch.
PowerShell with SharePoint 2013 and Office 365 - EPC GroupEPC Group
PowerShell with SharePoint 2013 and Office 365
Web: www.epcgroup.net | E-mail: contact@epcgroup.net | Phone: (888) 381-9725 | Twitter: @epcgroup
* SharePoint Server 2013, Office 365, Windows Azure, Amazon Web Services (AWS), SharePoint Server 2010 & SharePoint 2007: Review, Architecture Development, Planning, Configuration & Implementations, Upgrades, Global Initiatives, Training, and Post Go-live Support with Extensive Knowledge Transfer | Custom Branding and Responsive Web Design (RWD)
* Health Check & Assessments (Roadmap Preparation to Upgrade to 2013 or 2010) - Including Custom Code & Solution Review
* Enterprise Content Management Systems based on Microsoft SharePoint 2013, Office 365 Hybrid Cloud (Both On-premises and cloud)
* Enterprise Metadata Design, Taxonomy | Retention Schedule Dev | Disposition Workflow, and Records Management | eDiscovery | Microsoft Exchange 2013 Migration \ Integration | Roadmap, Requirements Gathering, Planning, Designing & Performing the Actual Implementation
* Best Practices Consulting on SharePoint 2013, Office 365, SharePoint 2010, 2007 | EPC Group has completed over 900+ initiatives
* Intranet, Knowledge Management, Internet & Extranet-Facing as Well as Mobility (BYOD Roadmap), Cloud, Hybrid, and Cross-Browser | Cross-Platform Solutions for SharePoint 2013 with Proven Past-performance
*Upgrades or Migrations of Existing Deployments or Other LOB Systems (Documentum, LiveLink, FileNet, SAP, etc.)
* Custom Apps, Custom Application Development, Custom Feature, Master Pages, Web Parts, Security Model, Usability (UI) & Workflow Development (Visual Studio 2012, Visual Studio 2013)
* Migration Initiatives to SharePoint 2013 \ Office 365 and those organizations with both on-premises and cloud assets for a SharePoint Hybrid Architecture and Deployment
* Key Performance Indicators, Dashboard & Business Intelligence Reporting Solutions (PerformancePoint 2013, SQL Server 2012 R2, SQL Server 2014, BI, KPIs, PowerPivot, Scorecards, Big Data) and Power BI
* Experts in Global \ Enterprise Infrastructure, Security, Hardware Configuration & Disaster Recovery (Global performance considerations)
* Tailored SharePoint "in the trenches" Training on SharePoint 2013, 2010, 2007 + Office 365
* Support Contracts (Ongoing Support your Organization's 2013, 2010, or 2007 Implementations)
* .NET Development, Custom applications, BizTalk Server experts
* Project Server 2013, 2010, and 2007 Implementations
* SharePoint Roadmap & Governance Development: 6, 12, 18, 24 and 36 months (Steering Committee & Code Review Board Development)
A CSV (comma separated values) file can be created for a list of email addresses which are separated by a comma. On SurveyCrest, you can add all the email addresses of your contacts easily by simply uploading a CSV file made on MS Excel. This presentation explains how a CSV file can be uploaded on SurveyCrest.
Fuji Xerox My Prints is a powerful and easy to use solution which helps schools, libraries and organisations of any size to securely manage and control output.
My Prints is a comprehensive Secure Cost Management system designed to seamlessly monitor and control print / scan / copy jobs. This is provided via an easy to use administrative and user tool that can be securely accessed from anywhere on the network though a web browser.
Some of the key benefits include:
- Transfers accountability to users or departments by individually tracking activity.
- Creates environmental awareness.
- Reduces overall printing cost.
- Discourages overuse of IT resources.
- Increases document and device security.
- Improves efficiency by implementing Secure Release
For more information on how you can take control and manage your output with My Prints visit: http://www.fujixerox.com.au/solutions/MyPrints or call 13 14 12
(Module: Capturing requirements : importing a document)
At the end of this lab you will be able to import requirements that were captured in an external CSV document, and create individual artifacts within the requirements management project.
Given
► The JKE Banking Money That Matters project
Description
► In this lab, you are Bob the analyst. You sent out a spreadsheet to your team collecting new requirements. The team filled in the spreadsheet and handed it back. You will import those requirements, into the JKE project.
Exercise Tasks
In this exercise, you will complete the following tasks:
► Task 1: Import requirements that were captured in an external CSV document
Safety is the major issue anywhere. There are a lot of crimes happening every day. It would be very insightful to analyze the crime rate data to identify frequency of crimes, types of crimes, areas with a higher number of crimes etc. These insights will then have the potential to aid in proactive preventive measures by police increasing the level of safety in certain are.To add a different dimension to the analysis we considered California State University Los Angeles as our focal point and proceeded to project the data based on different parameters like time and distance. This would result in extracting key findings about crimes occurring around California State University Los Angeles and in Los Angeles.
Medical Device Manufacturing and Product Quality ProgramEMMAIntl
The purpose of this webinar is to discuss the FDA’s voluntary medical device manufacturing and product quality pilot program, CMMI Institute’s role in it and how manufacturers will benefit from this program.
I made this one, and it is good to show how to address the new requirements -- Context of organization, interesting parties, SWOT, PEST Analysis, Risk evaluation. just want to share with someone who need it ...
T.Rama Rao is a Sr.Consultant & Promoter of M/s.Saipharma Consultancy with Team Members having rich experience in handlig Project Management, Audits & Compliance Management, Regulatory Affairs, Pharmaceutical Product Development, GxP Training/ Operational Excellence
We work with Micro ,Small ,Medium and Large Enterprises in Pharma Formulations/Intermediates ,APIs,& Chemicals / Medical Devices/ BioTech / AYUSH/ Primary Pkg Mtrs/ Clinical Research Organisation .
Please visit our web site www.saipharmaconsultants.com for further details
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Quality Function Deployment (QFD) for Design ControlsEMMAIntl
The Food and Drug Administration (FDA) has requirements for medical device manufacturers to establish and maintain a quality system for their medical device(s). The requirement for a quality system does not necessarily introduce new concepts, but applies existing quality concepts to design, development, manufacturing, distribution and use of medical devices. Within the larger quality system requirement, a methodology to control device design and development of medical devices is required. This set of sub requirements is known as Design Controls. In this paper, the history and evolution of quality systems and their application to medical devices will be covered. A Quality tool that could be well applied to the specific area of design controls, Quality Function Deployment (QFD), is a focus of this paper.
Qumas Collaboration to Innovation Quality QMS PIMS 2014GBX Summits
Qumas Collaboration to Innovation Quality QMS PIMS 2014
How Enterprise Quality Management can protect your customers, keep you compliant, and have a positive effect on your bottom line.
www.pims.gb.com
www.gbx.uk.com
We are an Australian Business Consultancy with specialist skills and experience within the admin systems and processes used by Australian superannuation and wealth companies.
In essence, at QMV we manage projects and deliver complete programs of work for our clients.
Our services fall within five key areas. Let’s explore them in detail.
1. Platform
-Configuration Management
-Platform Review
2. Operations
-Compliance Service
-Reporting
-Business Process Review
3. Change
-Program Management Office
-Change Management
4. Quality
-Quality Management Planning
-Data Services
-Testing
-Due Diligence
5. Business
-Tender Support
-New Business
1. RCM Technologies (NASDAQ: RCMT) is a premier provider of business and technology solutions. These solutions are uniquely designed to enhance and
maximize the operational performance of customers by adapting and deploying advanced information technology and engineering services. For over 35
years RCM has been an innovative leader in the design, development and delivery of these solutions to commercial and government sectors. With offices
throughout North America and the capacity to delivery globally, RCM offers its customers solutions on a national and international scale.
Background
On March 10, 2011, FDA announced that a
consent decree of permanent injunction
has been filed against a subsidiary of a
Fortune 100 pharmaceutical and medical
device company, for failing to comply with
current good manufacturing practice
requirements. The action prevented that
portion of the company from
manufacturing and distributing drugs from
its PA facility until the FDA determines that
its operations are compliant with the law.
In response to the consent decree, the
company had the need to re-assess the
compliant and validated state of the
computerized system used to support the
product Quality Assurance processes and
implement remediation of any resulting
findings.
The project consisted of two phases: (1) the
initial assessment of the system validation
and compliance documentation; and (2)
major system remediation release to
address the assessment findings.
Goals
Assessment phase
Assess, document and
communicate the current system
compliance state, identify findings
and remediation action.
Remediation phase
Validate implementation of a major
system release in conjunction with
significant business process
changes.
Define and implement high Quality
Assurance standards demanded by
Consent Decree environment.
Meet deadlines established in
cooperation with FDA.
Approach
A team of senior RCM SMEs executed
the system compliance assessment six
weeks ahead of schedule and under
budget, providing the client with clear
findings and remediation strategy.
RCM formed two teams that engaged
on project System Validation and
Quality Assurance activities. RCM
developed and implemented a
solution-oriented “Center of
Excellence” approach to the project,
successfully providing vastly qualified
personnel and maintaining high-
productivity project environment.
Benefits
Expertise
RCM provided industry experts to
support both Systems Validation
and Quality Assurance initiatives
Quality and Consistency
RCM defined and implemented
project-specific candidate selection
and qualification criteria
Immediate Productivity
RCM provided pre-training on
relevant client SOPs, on-site
mentoring, leadership, orientation
and support, etc.
Personnel Retention
RCM implemented retention
initiatives and motivators
RCM provided dedicated on-site
management presence
Cultural Alignment
RCM exemplified consistent
positive project culture
Contact:
Laura DeLea- Account Executive
201-400-9774
Case Study
Consent Decree Remediation Project
Computer Systems Validation and Quality Assurance
RCM’s mission is to be in a
leadership position in its
industry by providing
responsive, high-quality,
reliable, technologically
advanced, and cost-effective
services that enable its
customers to meet their
business objectives