Complaints Management - Medical Devices, Pharma, Healthcare Companies

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.

The Complaint Management encompasses two major parts a) Logistics complaints consisting of damaged goods, wrong shipments, product returns, wrong invoice, etc and b) Complaints arising from Adverse drug effects, Side effects, Interactions with other drugs. These are collectively known as Adverse Drug Events (ADE) and can be fatal for the consumers. The ADEs if not managed well could result in severe consequences from warnings,marketing suspension,fines,product recall,litigation and thus effecting life-sciences companies in more ways than one.

To make the Complaint Management solution robust and agile, let us review the overall process & process steps:
a) Complaint Registration
b) Complaint Assignment and Processing
c) Root Cause Analysis including Corrective Action and Preventive Action (CAPA)
d) Reporting ,Alerts,Trending and Communication
e) Complaint Closure
f) Proactive Monitoring

The weakness in the above process management can be many. The underlying technical systems are low in technical and business value and require multiple manual interventions in the complaint life cycle. The systems are managed on regional basis and thus lack to give a global view of complaints on a given product. The integration between the systems catering to different parts of complaint stages may be missing totally or partially and thus inducing the delay in tracking and monitoring of complaints. The analysis of adverse drug events will involve multiple departments e.g. Quality,Research & Development,Product Life Cycle management teams and the complaint system should facilitate collaboration amongst various teams involved. Because of mergers and acquisitions it is quite likely that complaint handling process is not consistent across the organization.

It is critical for Pharma companies to have a standardized process for Complaint Management which is supported by solution advanced in both technology and functionality to meet the above challenges. The salient features of an effective solution are listed as follows:

• Web based application catering to all stages of Complaint life cycle
• Capability for Workflow, Alerts and Notifications
• Auto routing of Complaints
• Ability to manage documentation and attachments throughout Complaint life cycle
• Internal and Customer view of Complaints
• Tracking & Monitoring of Complaints
• Complaint Escalations
• Single database for all Complaints
• Multiple language capability
• Electronic Signatures and Audit Trail
• Integration with Enterprise Applications (ERP) , Quality Management, Product Life Cycle Management applications
• Integration with Adverse Event handling process
• Collaborative framework to manage complaint process across cross-functional departments
• Regulatory and Internal Reporting,Trend Analysis
• Minimum manual intervention
• Scalable Technical Architecture
• High Performance and Response times
• Security & Authorization for relevant access control

Apart from increased customer awareness and because of ever rising regulatory and market pressures on Pharma industry, there is renewed focus on Complaints Management.Pharma and Healthcare companies should review their Complaint Management processes and systems to incorporate the required capabilities that arenecessary to meet current market challenges.

A robust and effective solution will not only help in reduction of cost of compliance but will also result in increased customer loyalty through improved response times and better customer experience

Analytics & Cloud Computing

ABCs of Cloud Computing

Cloud in simple words is 'Pay as you use'. Cloud computing is analogous to the way we pay for our utilities like electricity or water based on the consumption. The underlying Infrastructure is owned  and managed by some third party and cost is billed to us in form of units consumed

Following are the three distinct characteristics of cloud computing which differentiates it from normal hosting services:

a)Demand: - Massive computing power on demand available immediately
b)Unlimited Elasticity: - Infinitely scalable on demand and resources can be released as well when not required
c)Low cost of ownership/ Affordable: - Pay as you use for minutes , hours or days based on capacity used.

Cloud Types?

a)Public cloud: - This is pure form of cloud where infrastructure, service is provided & managed by third party and we pay as we use.
b)Private cloud: - There is lot of debate around whether private cloud is actually a cloud because all infrastructures is still managed and owned by a company. In real sense this is not a cloud but just a internal shared network which is not satisfying the parameters of cloud computing but still a topic worth for a debate because of different view points from Industry.
c)Hybrid cloud: - Combination of private and public cloud.

Business Intelligence \ Data warehousing & Cloud Computing
Growing data in TBs, high performance expectations, low TCO, easy to acquire, organize & manage are some of the key expectations for any data warehouse application. BI in cloud is a very new approach for Business intelligence which can address all future expectations of data warehouse with following distinct vantages :

1.No need to install any hardware or software: - Access through web browser ( depends on kind of cloud service)
2.Unlimited bandwidth and geographical scalability: - System will automatically assign or release computing resources based on requirements
3.Shorten BI implementation cycles and help BI implementations to become more flexible & scalable.
4.Pay as you use - If you use less, pay less: - This is as opposed to current scenario where an organization installs their own infrastructure and always pay for the peak load.
5.Common Data exchange method (Transaction data feed to cloud BI):- Lot of items to be sorted out at time of actual deployment.
6.Availability of best-of- breed infrastructure and services with unlimited computing capacity (based on the type of services purchased)

BI Delivery options
Business Intelligence can be on a private cloud or a public cloud depending on business needs and usage type

1.Delivery options based on service  :- BI  clouds generally have following service options

a)Infrastructure-as-a-Service (IaaS) :- Here vendors like GoGrid ,Rackspace , Right scale or Amazon etc can provide hardware and system software and then you can deploy  own BI/ DW applications . Here you only pay for hardware and system software on usage basis but you still need purchase your BI/ DW applications.

b)Platform-as-a-Service   (PaaS) :- BI Players like Good Data, Pivot Link etc  which provide the BI/ DW platform but you need to develop and deploy the same as per your business requirements

b)Software-as-a-Service(SaaS): -Here vendors like SAP Business Objects ,salesforce.com are offering 'On Demand BI' or prepackaged end to end BI solution with limited customization. This is typically suitable for Small & medium Enterprise category for cost advantages and short cycled BI projects.

All these options are analogous to a transport industry
a)Roads are basic Infrastructure  (analogous  to IAAS )
b)Cars , Buses are the platforms which runs on roads (analogous to PAAS)
c)GPS can guide as how to reach correct destinations(analogous to SAAS )

2.Delivery options based on  Usage Type: - Like staging data in local systems but accessing reports in cloud or using cloud for Prototypes as a sandbox or a fully live application in cloud.

 BI in cloud: - Key Issues

BI in cloud enables a variety of new possibilities and it can be future of BI looking at the current trends in BI industry .   However, it's not a silver bullet and one might need to evaluate following parameters as well.

1.Easy migration from one cloud to other cloud
2.Common data exchange mechanism: Data flow mechanism & strategy between local transaction system and BI cloud.
3.Deciding on what should be done locally and what should be done in cloud: - How much to use from cloud as there is too much offered by cloud
4.Security, Risk and Regulatory concerns: -While managing data outside the enterprise, data security can be a key concern .
5.Measuring long term cost of ownership
6.New era BI technologies like in-memory etc: - Are they being developed keeping cloud into consideration.