Being in the Life Sciences industry for last 18 years, I have always been challenged on finding solutions that can help reduce the compliance cost, accelerate the time to market, ultimately making more efficient use of R&D dollars.

Whether it is document management, intranet & extranet, complaints handling, quality control and assurance, risk assessment or simple product development process, every functional area within the organization is looking for a robust solution that can strategically help to increase the efficiency and effectiveness of the employees while reducing the costs. To me the answer came with SharePoint 2010.

SharePoint 2010 provides both out-of-the-box functionality and a platform for customization. Because of this, the health and life sciences organizations get a range of flexible options for meeting their business needs. With robust business intelligence capabilities and no-code solutions, people throughout your organization, regardless of their technical expertise, can access information from databases, reports, and business applications.

With its rich set of integrated capabilities built on a single, scalable platform, SharePoint 2010 provides tools that you can use to reduce costs in several ways. By consolidating intranet, extranet, and Internet sites on a unified platform, you can reduce your maintenance, training, and infrastructure management costs. Because you can deploy SharePoint 2010 on-premises or in the cloud with SharePoint Online and Office 365, you have the flexibility to scale up and out quickly as your business needs change.

SharePoint can empower your staff to work together more effectively, using self-service capabilities. Also, by combining your content management, business productivity, and collaboration solutions on SharePoint, you can offer everyone on your team the same resources and the right information to make smarter business decisions. In my experience this has been particularly helpful when the team is working on product development – all the documents are integrated in one place, easy to reference and easy to share and most important of all streamlines the approval process thereby making the entire development process highly efficient.

With SharePoint, you get an adaptable work flow to direct the flow of information to support your company’s unique business processes. You configure workflows to automate actions such as creating non-conformances and initiating corrective and preventative action (CAPA) requests automatically. You can also tailor reporting to monitor and research specific trends, due dates and items seamlessly through integration with other services.

In regulated industries such as life sciences, the architecture of your enterprise information systems takes on a strategic importance. Solutions architecture affects how you collect, interpret and share information. It can either impose limits on how you do business or enable greater efficiency and flexibility.

The BYOD question
The most common concerns on implementing a BYOD policy start with security issues and data management issues. But the concerns reach far beyond: from security to end point management and from overload of data and data management to impact on infrastructure and organization. According to Information Week study, the number of organizations standardizing a mobile device platform has dropped from 73% to 58% in 2010 to 2011.
Here are some questions to seek answers to before implementing the BYOD policy
· Device – Will the device choice be unrestricted or chose from a list?

· Cost of data – Who will pay for the data plan – a monthly quota would be issued or will it be expense report based?

· Cost of device – Will it be jointly shared by organization and employee or solely employee owned?

· Security – What kind of security is needed –network access, remote wipe, encryption, device restrictions, cloud backup?

· Infrastructure – will the network infrastructure handle the onslaught of data and increase in complexity?

Next Week – What are some of the steps organizations can take to ensure a smooth rollout of BYOD?

SharePoint is highly customizable and very user friendly software that provides a strong base for Pharmaceutical and Healthcare organizations to shape functionality and enable them to meet the requirements of a wide variety of users across the ecosystem. These solutions support several functional areas including research & development, quality management, manufacturing & operations, clinical data management and customer service.
SharePoint allows many things including document management, designing electronic forms for the collection of data for everyday operational, managing lists and trackers of information centrally, and managing distribution of information and collaboration between geographically dispersed team. It also helps implement interactive workflows in line with SOPs to better manage processes and provides real-time metrics and KPIs through dashboards to facilitate decision making.

Regulatory compliance, complaints handling, CAPAs are a constant challenge for pharmaceutical companies. Microsoft SharePoint Server 2007(MOSS), has more complex applications with the capability to be a complete enterprise content management system and was able to address the regulatory and compliance challenges of pharmaceutical organizations.

Some of the key additions to MOSS were:
• enterprise search capabilities of both structured and unstructured content
• full content management including libraries, policies, auditing, and compliance
• business document workflows
• control of documents through detailed extensible policy management
• use of browser-based SharePoint forms for gathering information
• the capability to integrate business intelligence features by accessing other data sources (SAP, Oracle, etc.) to present real-time dashboards.

In order to address the internal needs of the organization, the IT departments create their own taxonomies, libraries, folder structures, policy and rights, etc. This type of SharePoint implementation can easily get out of control quickly. Therefore, it is imperative that both IT and quality assurance take the lead in the effort for an enterprise deployment of SharePoint and have a step by step plan.

To ensure control and compliance of the SharePoint implementation, the organization needs to establish a governance model to address all components of the implementation. In particular, the governance model should define the infrastructure requirements; address the establishment of overall policies for libraries, folders, templates, workflows, and documents; define roles and responsibilities; establish information rights processes for controlling access; and establish the taxonomy and structure of the content.

Following the governance model will ensure a successful deployment; however, to ensure the SharePoint deployment adds value to the organization, the deployment must align with the business goals of the organization. This alignment will expand the use of SharePoint across the organization providing easy access to structured and unstructured information to all who need it.

Through the use of SharePoint and the associated governance model, the use of human capital can be optimized by providing individuals with a broadly accessible connection to the people, processes, and information, customized to their role, task, and personal work style.

SharePoint also addresses confidentiality, integrity, and authenticity of electronic records through access control and permission to the records on either the individual record level or a document library level. In MOSS, all items maintain an auditable system of records.
Another feature of a compliant document management system is the ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. SharePoint addresses this requirement as well, enabling output to be generated in XML (extensible mark-up language) or XPS (XML paper specification) formats.

SharePoint is becoming increasingly popular due to its complete suite of enterprise content management system that can be easily adopted by various functional areas within an organization.

There are some fundamental benefits in employing collaboration across the organizations, few of them being:

1. Increase in productivity and efficiency – When employees have access to previous references and solutions achieved, they save time in rehashing the same activity. It can result in saving of innumerable hours of employee’s time leading to increased productivity.
2. Promotes innovation – Collaboration fosters innovation by aggregating and increasing the availability of research and information.
3. Increased knowledge transfer -It also leads to increased knowledge sharing amongst the employees
4. Establishes the sense of social community – Increased accessibility to peers, colleagues leads to enhanced sense of social community amongst the employees resulting in healthier and more satisfactory work environment

Across the value chain– An organization cannot decide to implement a social media campaign at the end of marketing process by putting up a facebook site or anyoutube campaign.  Participation by partners, customers, employees and other stakeholders including the market and industry allows the organization to assess the strategy and tactics to increase the bottom-line.

• HR- social media can play a powerful role in the human resources by its efficiency in attracting talent, vendor referrals and community building ( of former and future employees)
• Marketing – Social media could be useful in generating leads, increasing sales ( through contests and discounts), increased conversion, branding and PR, audience engagement and community building
• Customer relationship management -Inviting the consumers to have an open dialogue in the initial planning process helps to incorporate valuable feedback. During the marketing and selling process, social media could be used to generate brand awareness, brand promotion through deals and discounts and fostering brand loyalty and advocacy. After the sales has been achieved, social media could be used to gather valuable feedback from customers

There are some issues acting as roadblocks in comprehensive adoption of social media by organizations

• Accountability – It is not clearly defined as to who owns the social media in the organizations, which leads to the responsibilities about owning and managing becoming ambiguous.
• Lack of formal social media implementation policies and procedures
• No clear guidance on amount of money, resources and time required in the implementation for different organization sizes

Maintaining security, privacy, ownership and managing risk

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Our strength is our people that are thought leaders, passionate about mobility and process experts that believe in the innovation that mobility can bring to critical enterprise business processes.