The Solution Architect operates in a complex Research andDevelopment environment with high levels of accountability where ease of access and analysis of vital data is paramount to the discovery of new drugs within the regulated pharmaceutical industry.
The Architect will ensure that common architecture decisions are taken and implemented consistently across the business and IS, providing IS/IT architectural expertise and technical direction to system development and integration projects for IS/IT solutions and will be an Architecture Specialist in one or more areas (either Technical or Business focused).
Accountabilities and Responsibilities. The role will be accountable for architecting and designing comprehensive solutions that meet business requirements. The Architect will partner with project managers, business analysts, and solution engineers to create solutions and meet the financial targets (cost and benefits).
The Architect also ensures that the subsequent detailed design remains in line with the chosen solution and that the solution delivers value for money.
Candidates will have demonstrated
- successful delivery of an information and systems roadmap (taking ownership and driving end to end)
- subject matter expertise in technologies around enterprise search, semantics and taxonomy (ie collect, mashup, enrich, index, search)
- current insight, knowledge and experience in delivering Information and System Architecture blueprints
- ability to speak with informed authority about external industry standards and blueprints (values and challenges) in the space of enterprise search
- working in a global organisation with complex/geographical context
- strong communication, influencing and negotiating skills, operating to VP level
- strong relationship and team building skills
Background
- Bachelors degree in Computer Science with 10+ years experience in software solutions delivery with 5+ years as solution architect
- Degree or experience in life sciences is an asset
Soft Competencies
- Consistently applies enterprise architecture principles and assets to the design of new solutions and services in response to business requirements using technologies and components that are adaptable to changing business conditions.
- Understands, communicates and ensures the impact of evolving standards on enterprise-wide systems are considered and acted upon.
- Engages with project teams to ensure assets are leveraged effectively when developing solutions and services to ensure focus on long-term benefits and value realisation.
- Communicates the benefit and value and the impact of enterprise architecture standards and assets to non- IS/IT personnel in a way that is understandable.
- Utilises business acumen in working with business leaders to design improved services, processes and assets for effective knowledge and information dissemination.
- Ensures the availability, integrity and searchability of knowledge and information through the application of formal data structures and protection measures.
- Maintains an active awareness of external standards and applies in an organization’s context to ensure integrity of data and ability to manipulate across partners and external bodies.
Proven experience in a significant number of the following technical domains.
- Search, Semantics and taxonomy (For example – Autonomy, SchemaLogic)
- Integration technologies (For example – SOA, ETL)
- Process Modelling (BPMN)
- Information Modelling (For example – Enterprise Architect, System Architect)
- Software architecture (.Net and/or J2EE)
- Enterprise architecture tools (including Asset management) (For example – TROUX, Essential)
- Enterprise Content Management (For example – Documentum, Sharepoint)
- Analytical tools (For example – Tibco Spotfire, SAS, Business Objects)
- Collaboration tools (For example – MS OneNote)
- Database architecture (For example – Oracle)
Group task management finally makes sense with Stacks – Group task management Tracking and Follow up Software.
- Assign and track tasks with ease
- Get alerts for new and completed tasks
- Instantly view others’ tasks and timelines
Visualize the Workload
With Stacks it takes one glance to instantly decipher everyone’s workload. No information hidden 10 clicks deep and no complicated Gantt charts.
Assign Tasks to Get Responses
Email lacks accountability. Stacks fixes that problem. Stacks ensures the ball isn’t dropped and that someone always has ownership of a task.
Background Alerts
Stacks provides you with subtle alerts when items are added or completed by others. This helps if you do not like distractions.
What others are Doing? – Transparency
Know what each team member is focused on with a click. See who’s overwhelmed and who has time for a coffee run.
Sorts – Filter – Prioritize
Your task management solution should handle the hard thinking, not you. Stacks gives you the power to see only the information you’re interested in.
Simple Task Tracking and Followup Software
It takes seconds to add and update tasks. For more complex requirements we’ve tucked away features that don’t get in your way unless needed.
In today’s business the following functions are critical to your document management success.
- Environment
- Organizing
- Managing
- Sharing
Livelink Electronic Document Management for Healthcare Pharma Industry
Open Text’s Livelink ECM – Document Management provides the essentials to help you reduce the amount of time and effort spent managing your corporate documents.
Securely capture, organize and control all forms of electronic documents in a centralized repository. Begin improving productivity by controlling, automating, and auditing document-centric business processes.
- Implement good corporate governance practices and reduce the risk of non-compliance
- Improve employee productivity through faster and easier information retrieval
- Increase return on investment (ROI) through accelerated productivity and low cost of deployment and ownership
- Leverage other technology investments by scaling OpenText Document Management to grow with your needs
Benefits of Open Text’s Livelink ECM – Document Management
- Extract the value in your electronic document assets
- Improve personal productivity and corporate agility
- Increase ROI through low cost of deployment and ownership
- Leverage technology investments
- Reduce corporate risk through good governance practices
OpManager is a complete, end-to-end network monitoring software that offers:
- Advanced Fault And Performance Management Across WAN
- Voip Services
- Network Devices
- Servers
- Applications
- Databases
- Other IT Infrastructure Such as Printers and UPS
OpManager is easy-to-install, easy-to-use, and works right out-of-the-box. OpManager has all that you need to manage your IT infrastructure without being expensive or time consuming to implement. Learn why more and more Network professionals are choosing OpManager – a practical alternative to the large, complex and expensive network management frameworks.
- Analyze WAN traffic using Cisco Netflow
- Automate Network Change and Configuration Management
- Monitor and troubleshoot VoIP performance
- Resolve outages quickly with support for SNMP traps and Syslogs
- Troubleshoot WAN Latency Issues with Cisco IP SLA
- Understand application performance and how it impacts the network
- Visualize your network with rich and customizable maps
Adopting Service Oriented Architecture (SOA) or moving into cloud computing architecture, as an IT manager of health-care systems, you will come accross Enterprise Service Bus (ESB) terminology.
Enterprise Service Bus (ESB) provides fundamental services for complex architectures via an event-driven and standards-based messaging engine (the bus). Developers implement an ESB using technologies found in middleware infrastructure products created based on recognized standards.
Key functions provided by ESB for Healthcare and Life Sciences
| Complex event processing | event-interpretation, correlation, pattern-matching |
| Invocation | support for synchronous and asynchronous transport protocols, service mapping (locating and binding) |
| Management monitoring, audit, logging, metering, admin console, Business Activity Monitoring(BAM) | |
| Mediation | adapters, protocol transformation, service mapping |
| Messaging | message-processing, message transformation and message enhancement |
| Other quality of service | security (encryption and signing), reliable delivery, transaction management |
| Process choreography | implementation of complex business processes |
| Routing | addressability, static/deterministic routing, content-based routing, rules-based routing, policy-based routing |
| Service orchestration | coordination of multiple implementation services exposed as a single, aggregate service |
Key benefits of Enterprise Service Bus (ESB) in Healthcare and Pharma Industries
- Faster and cheaper accommodation of existing systems
- Increased flexibility easier to change as requirements change
- Incremental patching with zero down time enterprise becomes refactorable
- More configuration rather than integration coding.
- No central rules engine no central broker
- Predefined ready for use service types
- Scales from point solutions to enterprise wide deployment distributed bus
- Standards based
Commercial and Open Source Enterprise Service Bus (ESB) Products
- Apache ServiceMix
- IBM WebSphere ESB
- Microsoft BizTalk Server
- Mule
- Open ESB
- Oracle Enterprise Service Bus
- Petals ESB
Reference : ESB at Wikipedia
Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
February 17, 2011Much has been written about “why” to validate. The Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry is an SOP-centric explanation of “how” to validate. Creating a state of sustainable compliance with FDA regulations including 21 CFR Part 11, Electronic Records; Electronic Signatures is daunting task.
This handbook follows FDA guidelines and “Best Industry Practices” in defining the roles, responsibilities, and requirements of computer and computerized system validation for the pharmaceutical, biotechnology, and medical device industries. It details the requirements for Standard Operating Procedures and Protocols for User Requirements, Functional Requirements, Design Specifications, Installation Qualification, Operational Qualification, and Performance Qualification.
21 CFR Part 11 Assessment and validation gap analysis methods are prescribed to determine the state of compliance of systems with current regulation. The! first requirement of 21 CFR Part 11 is “Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.” This book explains how to comply with this and other requirements of 21 CFR Part 11.
Author – Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry
Stephen Goldman is a Senior Compliance Director and Consultant specializing in 21 CFR Part 11 training, assessment, remediation, validation and project management to provide sustainable compliance in the regulated pharmaceutical environment. He has provided Subject Matter Expert guidance and training for gap analysis and remediation of computer systems validation for a major pharmaceutical company under an FDA Consent Decree. He has performed engineering and validation services for two remote data entry systems for use in clinical trials.
Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare
By Guy Wingate (Editor)
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated.
Computer Systems Validation
The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture.The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement.
He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.
Basecamp offers to-do lists, wiki-style web-based text documents, milestone management, file sharing, time tracking, and a messaging system. It also offers integration with 37signals’ own Campfire product.
Basecamp is proprietary software available in the English, Spanish, French, Italian, German, Finnish, Portuguese, Danish, Dutch, Polish, Swedish, Greek, Russian, Hungarian, and Japanese. Translations into additional languages are planned.
Basecamp is the top choice for entrepreneurs, freelancers, small businesses, and groups inside big organizations.
Over 5 million people worldwide have used Basecamp to collaborate on over 4 million projects, track 57 million hours of work, share 46 million files, and complete 43 million to-dos.
Project Management Software – Online Collaboration – Basecamp
Trusted by millions, Basecamp is the leading web-based project management and collaboration tool. To-dos, files, messages, schedules, and milestones.
Assembla is a collaborative project management service for open-source and commercial software. The service rents development applications to other companies online, reducing the cost of software development.
Assembla workspaces to accelerate software teams
Ticketing and issue management, Subversion, Git, Mercurial, Wiki, and other collaboration tools to accelerate development.
Free starter offers include free subversion, free git, stand up/scrum reporting, and unlimited free services for public communities and open source projects.
Accelerate your team with classic collaboration tools like a Wiki, message board, shared files, and chat. Assembla packages them into a space with one team list and one activity stream. Your users will find it easy to join a team and see what is going on. You get out of the business of forwarding emails.
The AMA Handbook of Project Management by Paul C. Dinsmore and Jeannette Cabanis-Brewin
CAPM In Depth: Certified Associate in Project Management Study Guide for the CAPM Exam by Paul Sanghera
The Essence of the PRINCE2: Project Management Method by Colin Bentley
Overview of the PMBOK® Guide: Short Cuts for PMP Certification by Deasún Ó Conchúir
Achieve CAPM Exam Success: A Concise Study Guide and Desk Reference by Diane Altwies and Frank Reynolds
PMP Project Management Professional Study Guide by Joseph Phillips
Achieve PMP Exam Success: A Concise Study Guide for the Busy Project Manager by Margaret Chu, Diane Altwies and Janice Preston
Project Management Workbook and PMP/CAPM Exam Study Guide by Harold Kerzner and Frank P. Saladis
Project Management: A Systems Approach to Planning, Scheduling, and Controlling by Harold Kerzner
PMP: Project Management Professional Study Guide by Kim Heldman
The Essence of the PRINCE2: Project Management Method by Colin Bentley
PMI Risk Management Professional (PMI-RMP) Examination Specification by Project Management Institute
PMI-Scheduling Professional (PMI-SP) Examination Specification by Project Management Institute
Project Scheduling and Cost Control: Planning, Monitoring and Controlling the Baseline by James C. Taylor
Program Management Professional (PgMP): A Certification Study Guide with Best Practices for Maximizing Business Results by Craig J. Letavec, Steven C. Rollins and Diane C. Altwies
A Guide to the Project Management Body Of Knowledge (PMBOK® Guide) by Project Management Institute
The Fast Forward MBA in Project Management by Eric Verzuh
Program Management Professional (PMP) Examination Specification by Project Management Institute
PgMP: Program Management Professional Study Guide by Paul Sanghera
CAPM/PMP Project Management All-In-One Exam Guide by Joseph Phillips
PMP: Project Management Professional Exam Study Guide Deluxe Edition by Kim Heldman, Claudia Baca and Patti Jensen
Preparing for the Project Management Professional (PMP) Certification Exam by Michael W. Newell
The McGraw-Hill Guide to the PMP Exam by James P. Lewis and Robert E. Dudley
CAPM Certified Associate in Project Management All-in-One Exam Guide by Joseph Phillips
PMP: Project Management Professional Study Guide by Kim Heldman