Regulatory Compliance with SharePoint

Introduction – Regulatory Compliance

This post describes how Microsoft SharePoint® can be applied to manage common regulatory compliance requirements in companies of all sizes.  Using SharePoint avoids proprietary system lock-in.  With SharePoint Online, a solution is easy to deploy by eliminating up-front costs for IT Infrastructure and Software Licenses.

A Technology Advantage

As a platform for quality applications, SharePoint can integrate and streamline the flow of information throughout your enterprise for more efficient collaboration and smoother regulatory compliance.

By designing a SharePoint solution that is specifically tuned to the fundamental process of regulatory data management, your quality initiatives can be a competitive asset, not a liability. Beyond simply facilitating compliance, SharePoint solutions can also reduce compliance costs, automate quality activities and accelerate your time to market, ultimately helping you make more efficient use of R&D dollars.

Simplified Web Deployment

SharePoint solutions allow you to distribute information and capabilities via the web and configure the interface to fit your unique requirements. Your users have real time access to the latest information through a web browser eliminating the need for client by client installation upgrades and maintenance.

Scalable, configurable and adaptable

A SharePoint architecture has the flexibility and scalability to fit a changing regulatory environment.

Configurable queries workflow and alerts

Configure workflows to automate actions such as creating non-conformances and initiating corrective and preventative action (CAPA) requests automatically. Tailor reporting to monitor and research specific trends, due dates and items.  You can monitor data for trends and events using RSS feeds and email alerts.

Solutions developed to address the specific challenges of regulated markets

More than simply limiting your exposure, a SharePoint solution architecture can improve your efficiency and effectiveness. Accelerate your time to market through smoother regulatory data management. A SharePoint solution can also improve your competitive advantage and standing with shareholders.

Transforming paper based process

Integrate structured and non-structured data using SharePoint. You can replace traditional paper based process with more efficient workflows that reduce cycle times, accelerate time to market, streamline approvals and improve audibility.

SharePoint Compliance Solution Possibilities

SharePoint presents a revolutionary potential to regulatory data management.

Global – Full language localization.

Accessible – Manage quality data from any location in the world with a web browser. Different groups can access data and improve operational efficiencies and product knowledge across organizational boundaries.

Powerful – SharePoint provides one of the most sophisticated collaboration architectures available today by integrating powerful search features across structured and non-structured data.

Intuitive – Interfaces and work flows are designed with input from your regulatory professionals to manage the most complicated tasks with a simple to use navigation.

Configurable– SharePoint architecture provides configurable workflows, control of security zones, customized forms and powerful search tools that allow you to design and adapt the system to your environment.

Cost Effective – The use of SharePoint Server as a foundation platform lowers the initial cost of implementation over proprietary solutions. Plus, the ability to seamlessly add workflows, forms and web parts lowers the total cost of ownership.

Trusted – Microsoft solutions are used by some of the most recognized companies in the world.

Complaints – Intake, Response and Product Complaints

A SharePoint based complaints system can provide a highly configurable management tool for all activities associated with complaint handling in a regulated environment.

  • Manage the investigation and resolution of customer complaints
  • Maintain customer and product information
  • Provide workflow and review processes with issue resolution and system notifications
  • Associate multiple products, manufacturing sites, vendors or classifications into each complaint
  • Attach files, photos and other documents
  • Add workflow elements including decontamination, product evaluation, event investigation, disposition and others
  • Manage activities, cancel or reassign actions and change due dates while maintaining full audit trail and rationale documentation
  • Configure reports with email distribution, scheduling and graphing capabilities

Corrective and Preventative Actions – Risk Evaluation and Mitigation Strategy

A Corrective and Preventative Actions (CAPA) solution can provide management capabilities that would allow users to initiate, evaluate, assign, monitor, review and approve each CAPA record. Security and access can be controlled by group and function to allow you as much control over the process as you wish.

Possible solution features

  • Link multiple issues from various sources to each CAPA
  • Customize classification schema to facilitate trend analysis
  • Add multiple classifications to each CAPA for trending
  • Include classifications for risk assessment, root causes and effectiveness monitoring
  • Generate CAPA approval workflows and circulate for Review and Approval
  • Create, assign and track activities and tasks through closure
  • Provide notifications and alerts of overdue items
  • Utilize electronic signatures where required

Configurable security

  • Security can be applied to users and groups to control who can be assigned to activities like approvals, investigations, effectiveness monitoring and others
  • Schedule and distribute reports via emailSharePoint allows full localization for complete presentation in the users preferred language

Accessible and Global

  • SharePoint allows full localization for complete presentation in the users preferred language
  • Web based applications can be accessed from anywhere while still enforcing all the security protocols that an organization applies to their remote users

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Chris Tsouris founded Strategic Computing over 20 years ago to deliver business empowering solutions through a superior commitment to technical excellence and customer service.  He is a seasoned speaker on Information Technology subjects including: Strategic Planning, Estimating Software Costs, Cloud Computing, Electronic Records, Regulatory Compliance and Master Data Management.

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