SharePoint –solution for regulatory/compliance challenges in Pharmaceutical organizations

01 Jun, 2012

SharePoint-based solutions are getting adopted widely across the Pharmaceuticals and Healthcare ecosystem. This is largely due to the ease of creating compliant SharePoint solutions with the SharePoint 2010 platform.
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.

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