SAP

Global Pharma Researh & Development (R&D) spend has witnessed the annual growth rate of about 10% each year in the last three years but for next three years it is forecasted to grow annually at mere 2%. On an average, the Pharma companies annually spend 20% of their sales revenue on R&D activities. The growth in annual sales revenue will be under pressure on account of patent expiry of money spinner drugs in next couple of years.  For example, patent for Lipitor (Cholesterol management drug) often referred to as billion dollar pill is set to expire next year. Inspite of the challenges, Pharma companies are planning to sustain to the almost same levels of annual R&D budget with minor yearly increase for next three to four years. Clearly there is a growing concern and strategies are being put in place to derive more mileage from R&D.

Continue reading " Pharma R&D Innovations:Need of the Time " »

Posted by Deepak Kumar at 8:41 PM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

What has helped retailers eliminate costs, manage assets and provide self checkout facility to customers? What has eliminated multiple resource requirements for handling and tracking packages and parcels in transport industry? What has off late reduced the burden of manual intervention at the toll gates?

No reward for guessing and it is RFID (Radio-frequency identification). Simply put, RFID (also sometimes referred to as Auto ID) outlines a technique of identifying an entity relevant to business, by use of radio waves (with the help of RFID tags and tag readers). Now various industries have seen multi faced utility of RFID. Let's assess its usage in Pharma Manufacturing with focus on regulatory compliance.

Continue reading " RFID in Pharma Manufacturing and Regulatory Compliance " »

Posted by Anand Krishna Sharma at 6:10 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

The blog discusses how Electronic Prescription will influence the pricing decisions of the Pharma companies which are already reeling under the margin pressures owing to patent expiry of most of the blockbuster prescription drugs in next 1-2 years. Reforms are being planned by the governments to rein in the rising cost of the healthcare and to bring it to affordable levels for the masses.

Continue reading " Role of E-Prescribing in Reducing Healthcare Costs " »

Posted by Deepak Kumar at 1:03 PM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

Pharma companies are trying to outsource more and more manufacturing activities to contract manufactures so that they can focus on core activities of drug discovery and marketing. One estimate pegs the annual revenue from contract manufacturing and research activities to approximately 180 Billion USD for year 2010 with the annual growth rate of approximately 11%.There is a rapid rise in the pharma contract manufacturing organizations in India and China in recent years and this will further aid to the growth of the contract manufacturing industry. The blog explorers various challenges that CMOs are likely to face in medium to long term timeframe.

Continue reading " Challenges for Pharma Contract Manufacturer Organizations " »

Posted by Deepak Kumar at 9:51 AM | Permalink | Comments ( 1 ) | TrackBacks ( 0 )

The concept 'Service Introduction' is gaining rapid popularity in IT world as an 'effective tool' to introduce a new application/service into an established system.

In short, Service Introduction is the management of activities to ensure that applications/systems being developed to meet all operational requirements before getting introduced to 'Production or Live' environment. It also has to ensure 'Maintenance teams' are comfortable in providing the required services from the day one.

Continue reading " Service Introduction- In IT space " »

Posted by Virupaksha Gopala Krishna Kalaga at 12:44 PM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

by Anand Krishna Sharma

Validation and adherence to regulatory guidelines is an integral part of any Life Sciences Company. One of the most popular IT systems in the market that form core of the functional system is SAP. SAP offers unique advantages, challenges and issues in catering to regulatory compliance due its inherent complexity, structure and processes. I would like to give a snapshot of such nuances in implementing Validation and compliance checks at a very high level in SAP environment.

Continue reading " Validation in SAP projects " »

Posted by Guest Blogger at 9:54 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

We heard of Preconfigured templates which will be kind of half the problem solved, ready to consume and jumpstart the implementation project.  On similar lines while I was looking at some of the ongoing legal changes that are to be complied in a time bound fashion,  I was wondering if we can come up with 'Preconfigured point solutions for accelerated legal compliance'.   Below is my thought process on same and wish to share view points with the ERP fraternity.

Continue reading " Preconfigured point solutions for accelerated compliance of ERP systems to regulatory changes " »

Posted by Udayakanth Kuppa at 9:28 AM | Permalink | Comments ( 1 ) | TrackBacks ( 0 )

Continue reading " Cloud Quotient of Life Sciences Enterprise - Part 2 " »

Posted by Hemant Pathak at 2:57 PM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

Continue reading " Cloud Quotient of Life Sciences Enterprise - Part 1 " »

Posted by Hemant Pathak at 4:37 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

Pharma organizations' typical pain point in IT deployment is that it takes a huge amount of testing to fulfill all the Computer Validation requirements as per the 21 CFR Part 11 guidelines. Testing cycle contributes ~40% of the application deployment cost and ~ 50% of the project timelines. The duration of an SAP implementation project in Pharmaceutical organization is atleast 20-30% longer and costlier than the similar project in engineering industry.

So what are the ways to reduce these timelines, effort and cost?

Continue reading " Is Cloud Testing a good option for SAP application's speedy testing in Pharma validated environments? " »

Posted by Ramesh J. Chougule at 6:49 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

by Ramesh J Chougule

While we know that discovering a drug costs 900 MSUD and takes approximately 15 years for a pharmaceutical company, there are technological advances like in silico simulations which are helping to improve effectiveness and reduce timelines in the early stages of the drug discovery life cycle. This technology is able to model the interactions and relationships among proteins, enzymes, receptors and chaperones. This gives a representation of various cellular processes, biochemical pathways and the associated cell signals.

Continue reading " Is In Silico Simulation the next big thing for Pharma? " »

Posted by Guest Blogger at 9:44 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

Using package software solutions for Enterprise Resource Planning Solutions (ERP) or Customer Relationship Management (CRM) for enterprise business transformation is very appealing. The reasons are many, not the least of which are:

•          Speed: Accelerated implementation

•          Knowledge: Built on industry best practices

•          Simplicity: Pre-integrated application suite or "stack"

Companies often speak of "vanilla" implementations where there is a strong reliance on "out-of-the-Box" functionality to drive process and organizational change.  However, it is a mistake to rely on software alone. Although fast implementation to achieve a target ROI is desirable, there are some risks that must be addressed. 

Continue reading " Don't rely on software alone to drive process transformation " »

Posted by Brandon Bichler at 3:07 PM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

Continue reading " Validation in Life Sciences Industry: Part 1 " »

Posted by Ravi Sanker R at 3:12 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

The  US  House  of  Representatives  passing  the  health  care  reforms  Bill was a top  news recently.  In  many  international  fora  it was received with applause. Although centered in the US, the event is viewed with global implications. Let us look at it with the IT perspective.

Continue reading " US Health Care Reforms: What is in it for IT " »

Posted by Hemant Pathak at 11:27 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

This blog is based on the experience of working in Pharma ERP Projects and Support environment. In this case ERP system used was is SAP R/3 system. One of the observation is Pharma companies have to follow and built in Validation and Compliance steps in both SAP Projects and  Production Support processes. Validation and Compliance ensures detailed electronic records and audit trails are maintained for system setup, design, specifications, testing, defects, modifications and are ensured through Validation Plan & Report for SAP Projects and through Validation Audits for SAP Production System. Validation and Compliance procedures also ensures Implementation and Maintenance of GxP business processes as per defined operating procedures in the underlying systems. This translates into presence of multiple tools and presence of complex processes which adds up to the cost of SAP Support setup. This blog examines and present ways to reduce such costs.

Continue reading " Optimize Operating Cost of Pharma ERP Support Setup " »

Posted by Deepak Kumar at 11:00 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

Pharma and Healthcare companies may have multiple ERP system lines in their Organization. This could be because of multiple reasons, for example how organization was structured in the past e.g. separate business divisions exist for patent drug production, Generics, Consumer Health or it would have acquired or got merged with other Pharma companies for better strategic fitment. Reasons apart, there is sufficient scope to optimize the total cost of ownership of ERP Systems by consolidation into a Global ERP System. Apart from the benefits arising from IT Infrastructure consolidation, the business case for consolidation of ERP systems will originate from the top management need of having a global view of business, to foster the standardization of the business processes across divisions, to improve visibility across supply chain, to bring efficiency in handling inter-divisional transactions and most importantly to emerge as a customer and market responsive organization.

Continue reading " ERP Consolidation Assessment in Pharma Companies:Cross-Divisional or Divisional " »

Posted by Deepak Kumar at 8:32 AM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

Continue reading " Building Validation and Compliance capabilities:Key Enablers for Pharma IT Offshoring " »

Posted by Deepak Kumar at 2:45 PM | Permalink | Comments ( 0 ) | TrackBacks ( 0 )

Inadequate handling and management of Product complaints is one of the top findings in the FDA warning letters to the Pharma and Healthcare companies. Though these companies have Complaint Management systems and procedures in place but clearly there is a need for robust solution to meet the challenges of regulatory compliance, having an advance alert mechanism for relevant business decisions on account of product safety and most importantly of being responsive to customer and regulatory authorities.

Continue reading " Pharma Complaint Management:Meeting the Challenges " »

Posted by Deepak Kumar at 11:34 PM | Permalink | Comments ( 1 ) | TrackBacks ( 0 )