Life Science Application, FDA and Cloud Computing


Life science application comes under Life sciences industry.

Life sciences consist of all fields of science that involve the scientific study of living organisms such as human beings, plants, and animals. The study of behaviour of organisms is only included in as much as it involves a clearly biological aspect. Biology and medicine remain main parts of the life sciences, having said that technological advances in molecular biology and biotechnology have directed it to a burgeoning of specializations and new interdisciplinary fields.

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R&D process in the life science can be a long and expensive undertaking. The product development process follows basic steps at a very high level as described below:

• Phase 1 – recognition of the particle, initial testing, and toxicology studies

• Phase 2 – more development, formulation, and human testing

• Phase 3 – double blind clinical trials to test efficacy and submission for FDA approval

Life science industry operates under the regulatory guidelines put forward by the Food & Drug Administration (FDA).

Food and Drug Administration is a federal agency in the Department of Health and Human Services. It is established to regulate the release of new foods and health related products.

The IT organizations in life science companies must adhere to the FDA guidelines put forth in the Code for Federal Regulations 21 Part 11 (CFR 21 Part 11). It defines how systems managing electronic records in life science firms must be validated and verified to ensure that the operation of and the information in these systems can be trusted.

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. CFR Part 11, as it is called, defines the criteria under which electronic records and signatures are considered to be reliable and equivalent to paper records.

Part 11 requires drug makers, manufacturers, biologics developers, biotech companies, and other FDA-regulated industries to implement controls such as audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule with some specific exceptions.

The actual Part 11 compliance process for any application includes software, hardware, and operational environment for the system itself. This allows an IT Team to answer the questions.

To prove these things the system validation process has three primary components, the Installation Qualification (IQ), the Operational Qualification (OQ), and Performance Qualification scripts. Organizations manage IT environment separately for the life science applications and with proper controls placed.

CFR does not ask organization on How to do it? but it states What needs to be done.

It all comes to convincing the FDA auditor whether the Cloud environment conforms to the FDA compliance requirements or not.

Cloud computing can improve and speed up process by reducing IT complexity and cost while allowing R&D organizations to focus on the ‘what’ of the R&D process in stead of the ‘how’.

But, how Cloud Computing and FDA can be brought on a same table is the biggest issue because:

Audit / Track of following items are needed.

Ø      Hardware serial number

Ø      System configuration

Ø      Equipment location

Ø      Exact versions off all installed software

FDA compliance in Public Cloud is impossible till now because you must be aware about the detailed information on the hardware and software that your system will be running on and even the exact physical location of the resources as well.

In Private Cloud, owner has control over all resources (Hardware, Software) and thus it is still possible.

In a nutshell, public cloud model just does not fit for the current practices for validation in FDA regulated organizations. However private cloud environment could be leveraged to provide life science companies with a short cut to completing overall system validation Public Cloud’s benefit “Economy of Scale” will be out of reach in this case.

A community cloud may be established where several organizations have similar requirements and seek to share infrastructure so as to realize some of the benefits of cloud computing. With the costs spread over less users than a public cloud (but more than a single tenant) this option is more expensive but may offer a higher level of privacy, security and/or policy (FDA) compliance.

What’s latest?

Amazon EC2 Dedicated Instances

Dedicated Instances are Amazon EC2 instances launched within your Amazon Virtual Private Cloud (Amazon VPC) that run hardware dedicated to a single customer.

NOTE: hardware dedicated to a single customer

Dedicated Instances let you take full advantage of the benefits of Amazon VPC and the AWS cloud – on-demand elastic provisioning, pay only for what you use, and a private, isolated virtual network, all while ensuring that your Amazon EC2 compute instances will be isolated at the hardware level.

You can easily create a VPC that contains dedicated instances only, providing physical isolation for all Amazon EC2 compute instances launched into that VPC, or you can choose to mix both dedicated instances and non-dedicated instances within the same VPC based on application-specific requirements

To get started using Dedicated Instances within an Amazon VPC, perform the following steps:

  • Open and log into the AWS Management Console
  • Create an Amazon VPC if you do not already have one on the Amazon VPC tab
  • Click on Launch Instance from the EC2 Dashboard
  • Select Launch Instances Into Your Virtual Private Cloud
  • Modify the instance tenancy from Default to Dedicated in the Request Instances Wizard
  • Start using your instance with the knowledge it will not share hardware with instances launched by other customers

Dedicated Instances certainly does help in building a case for FDA compliance and step in a RIGHT direction.
Reference:

http://www.hpcinthecloud.com/blogs/Cloud-Infrastructure-and-FDA-Compliance-92894189.html

http://www.hpcinthecloud.com/blogs/The-Possibilities-of-Cloud-in-the-Life-Sciences-Industry-91439669.html

http://www.hpcinthecloud.com/blogs/Negotiating-IT-in-the-FDA-Regulatory-Environment-92093279.html

http://aws.amazon.com/dedicated-instances/

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

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Five ultimate reasons to consider Cloud Computing for your business


When it comes to technology, you can never really know right from the start which trend is going to stick and which one will fade, so it’s not really a surprise that a lot of people were skeptical when cloud computing made an entry to the scene. Sure, the technology was still in its infancy and implementation was far from what we know today, but even so, cloud computing proved that the concept has a tremendous potential, and that it will forever change the world of technology and business. Fast forward to today, cloud computing is the ultimate technology to use in any field of work, with the most noticeable results in business environments. Simply put, whoever uses cloud computing in their business today has the upper hand. If you’re not convinced, here are the five ultimate reasons to consider cloud computing for your business. Continue reading “Five ultimate reasons to consider Cloud Computing for your business”

Platform as a Service Comparison- Force.com vs AWS Elastic Beanstalk vs Google App Engine vs Windows Azure


Platform as a Service Comparison

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  Force.com AWS Elastic Beanstalk Google App Engine Microsoft Windows Azure
Description Force.com is a cloud computing platform as a service system from Salesforce.com, that developers use to build multi tenant applications hosted on their servers as a service. AWS Elastic Beanstalk is an even easier way for you to quickly deploy and manage applications in the AWS cloud. You simply upload your application, and Elastic Beanstalk automatically handles the deployment details of capacity provisioning, load balancing, auto-scaling, and application health monitoring. Google App Engine lets you run web applications on Google’s infrastructure. App Engine applications are easy to build, easy to maintain, and easy to scale as your traffic and data storage needs grow. With App Engine, there are no servers to maintain: You just upload your application, and it’s ready to serve your users. The Windows Azure Platform is a Microsoft cloud platform used to build, host and scale web applications through Microsoft data centers.
Web-Site https://www.force.com http://aws.amazon.com/elasticbeanstalk/ http://code.google.com/appengine/ http://www.windowsazure.com/en-us/
Development Status Production Production Production Production
Technology Java, .NET, Ruby, Objective-C and PHP Java Java, Python C#, Java, PHP, Ruby
Open Source No No No No
Database Force.com database Microsoft SQL Server, Oracle, or other relational databases running on EC2. Google Cloud SQL, GAE doesn’t support external databases SQL Azure
Database as a Service Yes Amazon RDS, Amazon SimpleDB Yes Yes
API REST API AWS Elastic Beanstalk API or AWS SDKs Datastore, Blobstore,Email, XMPP, Channel, Memcache, Files API REST API and a managed API for working with the storage services
Pricing http://www.force.com/platform-edition/index.jsp?d=70130000000rza8 http://aws.amazon.com/elasticbeanstalk/#pricing http://www.google.com/enterprise/cloud/appengine/pricing.html http://www.windowsazure.com/en-us/pricing/details/
DevTest Environment Development Development ?
Free Trail 30 day Free Trail New AWS customers who are eligible for the AWS free usage tier can deploy an application in Elastic Beanstalk for free, as the default settings for Elastic Beanstalk allow a low traffic application to run within the free tier without incurring charges. Google App Engine is free up to a certain level of consumed resources. With new Spending Limit feature, customers who sign up for a new 3-Month Free Trial, MSDN or Cloud Essentials offer can utilize Windows Azure without any fear of getting charged as long as they keep the Spending Limit feature turned on.
Real-time web monitoring and analytics CloudWatch monitoring metrics Third-party tools can be used Windows Azure Application Monitoring Management Pack
Continuous Integration (CI) server CruiseControl is a continuous integration tool Hudson using the API to push new releases/versions to Elastic Beanstalk. Hudson – Continuous Integration for a Google App Engine application ?
Eclipse Plugin Force.com IDE on Eclipse 3.5 AWS Toolkit for Eclipse Yes ?

Cost Benefits of Cloud Computing


Cloud Computing is a “newsworthy” term in the IT industry in recent times and it is here to stay!

Cloud Computing is not a technology, or even a set of technologies — it’s an idea. Cloud Computing is not a standard defined by any standards organization.

Basic understanding for Cloud: “Cloud” represents the Internet; Instead of using application installed on your computer or saving data to your hard drive, you’re working and storing stuff on the Web. Data is kept on servers and used by the service you’re using; tasks are performed in your browser using an interface / console provided by the service.

A credit card and Internet access is all you need to make an investment in technology. Businesses will find it easier than ever to provision technology services without the involvement of IT.

There are many definitions available in the market for Cloud Computing but we have aligned it with NIST publication and with our understanding. NIST defines cloud computing by describing five essential characteristics, three cloud service models, and four cloud deployment models.

NIST's Architecture of Cloud Computing
NIST’s Architecture of Cloud Computing

Ref: NIST

“Cloud Computing is a self service which is on demand, Elastic, Measured, Multi-tenant, Pay per use, Cost-effective and efficient”. It is the access of data, software applications, and computer processing power through a ‘cloud’/a group of many on line/demand resources. Tasks are assigned to a combination of connections, software and services accessed over a network. This network of servers and connections is collectively known as “the cloud.”

Cloud service delivery is divided among three fundamental classifications referred as the “SPI Model,”

Cloud Service Models - IaaS, PaaS, SaaS
Cloud Service Models – IaaS, PaaS, SaaS

Software as a Service is a model of software deployment where an application is hosted as a service provided to customers across the Internet. By eliminating the need to install and run the application on the customer’s own computer, SaaS alleviates the customer’s burden of software maintenance, ongoing operation, and support. Salesforce is very popular Customer Relationship Management (CRM) software that is offered only as a service.

PaaS model makes all of the facilities required to support the complete life cycle of building and delivering web applications and services entirely available from the Internet. Google App Engine (GAE) is an example of PaaS. GAE provides a Python environment within which you can build, test and then deploy your applications.

Infrastructure as a Service (IaaS) is the delivery of computer infrastructure as a service. Rather than purchasing servers, software, data center space or network equipment, clients instead buy those resources as a fully outsourced service. Amazon Web Services (AWS) is one of the pioneers of such an offering. AWS’ Elastic Compute Cloud (EC2) is “a web service that provides resizable compute capacity”.

There are four deployment models for cloud services regardless of the service model utilized (SPI).

Public clouds refer to shared cloud services that are made available to a broad base of users. Although many organizations use public clouds for private business benefit, they don’t control how those cloud services are operated, accessed or secured. Popular examples of public clouds include Amazon EC2, Google Apps and Salesforce.com.

Private cloud describes an IT infrastructure in which a shared pool of computing resources—servers, networks, storage, applications and software services—can be rapidly provisioned, dynamically allocated and operated for the benefit of a single organization.

Hybrid Cloud represents composition of two or more cloud deployment models (private, community, or public) that remain unique but are bound together by uniform or proprietary technology that enables data and application portability.

Community Cloud represents infrastructure is shared by several organizations and supports a specific community that has shared concerns. E.g. FDA compliance needs specific controls where audit requirements can’t be met by other deployment models.

Cloud computing brings efficiencies and savings. The diverse benefits of cloud computing are undoubtedly worth pursuing. Cost-cutting is at the top of most companies’ lists of priorities in these challenging economic times. Having turned from revolutionary possibility into increasingly well-established custom, the cost of ‘outsourcing to the cloud’ is now falling dramatically.

In only paying for the resources used, therefore, operating costs can be reduced. After all, in-house data centres typically leave 85%-90% of available capacity idle. Cloud computing can lead to energy savings too, removing from individual companies the costly burden of running a data centre plus generator back-up and uninterruptible power supplies. Thus it results in reduction of CAPEX & OPEX.

Cloud Computing is in its formative years, but expect it to grow up quick. The prospective of Cloud Computing is mind boggling and the technology and business options will increase exponentially.

Still question remains, how Clouds are beneficial to the enterprises?

  • Focus on core business
  • Cloud computing increases the profitability by improving resource utilization. Pooling resources into large clouds drives down costs and increases utilization by delivering resources only for as long as those resources are needed.
  • Cloud computing is particularly valuable to small and medium businesses, where effective and affordable IT tools are critical to helping them become more productive without spending lots of money on in-house resources and technical equipment.
  • Cost savings
  • Remote access
  • Ease of availability
  • Real-time collaboration capabilities
  • Gain access to latest technologies
  • We can leverage the sheer processing power of the cloud to do things that traditional productivity applications cannot do. “For instance, users can instantly search over 25 GB worth of e-mail online, which is nearly impossible to do on a desktop.
  • To take another example, each document created through Google Apps is easily turned into a living information source, capable of pulling the latest data from external applications, databases and the Web. This revolutionizes processes as simple as creating a Google spreadsheet to compare stock prices from vendors over time, because the cells can be populated and updated as the prices change in real time.
  • Cloud computing offers almost unlimited computing power and collaboration at a massive scale for enterprises of all sizes.
  • “Salesforce.com has 1.2m users on its platform. If that’s not scalable show me something that is. Gmail is SaaS and how many users are on that?”
  • Multi-tenancy enables sharing of resources and costs among a large pool of users, allowing for:
  1. Centralization of infrastructure in areas with lower costs (such as real estate, electricity, etc.)
  2. Peak-load capacity increases (users need not engineer for highest possible load-levels)
  3. Utilization and efficiency improvements for systems that are often only 10-20% utilized.
  • Sustainability comes about through improved resource utilization, more efficient systems, and carbon neutrality.

But, are there any issues with Cloud Computing?

  • The benefits of cloud computing will not be realized if businesses are not convinced that it is secure. Trust is at the centre of success and providers have to prove themselves worthy of that trust if hosted services are going to work.
  • CIA (Confidentiality, Integrity, Availability)
  • Application performance
  • IT Security Standards – There are multiple standards for security protocol for IT systems that have yet to be implemented into cloud computing.
  • Regulatory compliance— the vendor will be required to participate in internal and external audits. They will need to find a way to accommodate auditors from all firms using their service. [FDA Compliance is not feasible yet.]

Let’s consider Facts and Figures before jumping into minor details of Cloud Computing. Compare the annual cost of Amazon EC2 with an equivalent deployment in co-located and on-site data centers by entering a few basic inputs (Ref: Amazon EC2 Cost Comparison Calculator).

Cost Component - Amazon EC2(Public Cloud), Co-Location, On-Site
Cost Component – Amazon EC2(Public Cloud), Co-Location, On-Site

Configuration:

High-CPU Instances: Instances of this family have proportionally more CPU resources than memory (RAM) and are well suited for compute-intensive applications.

20 High-CPU Extra Large Instance (75% utilization) and No. of Peak Instances – 5 with 10% Annual Utilization

  • 7 GB of memory
  • 20 EC2 Compute Units (8 virtual cores with 2.5 EC2 Compute Units each)
  • 1690 GB of instance storage
  • 64-bit platform
  • I/O Performance: High
  • Avg. Monthly Data Transfer “In” Per Instance (GB) -10 GB
  • Avg. Monthly Data Transfer “Out” Per Instance (GB)- 20 GB
  • Region: US-East
  • OS: Linux

Cost Details:

On-site

TCO On-Site
TCO On-Site

Co-Location

TCO Co-Location
TCO Co-Location

Amazon EC2(Cloud Computing)

TCO Amazon EC2
TCO Amazon EC2

Annual Total Cost of Ownership (TCO) Summary

Annual Total Cost of Ownership (TCO) Summary
Annual Total Cost of Ownership (TCO) Summary

Hence … Proved 🙂

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