Empowering Compliance Solutions

How often in your career have you gone looking for critical documentation only to discover that it is lost - never to be found again? I hope that this has not happened when you are having an audit. We all know how severe this can be and the consequences of lost documentation to your bottom line.

Have you ever tried to get parties involved in the signature process, only to find vacations and workload slow things down until it becomes a crisis? Your workload is now increased because you have to walk the document from office to office to get the required signatures before you can carry on with your job! We understand.

The big hurdle to going with paperless documentation software has, until recently, been the requirement for a non-digital signature. Technology is available now that provides the necessary support for compliance with FDA 21 CFR Part 11 enabling you to use digital signatures!

Achieving compliance with regulations in various industries can be a difficult and challenging task without a clear and detailed understanding of the regulation requirements. All departments need to comply with the regulations.

Our Fault-Intolerant Process Specialists™ have worked to help clients resolve their document and compliance management issues. We have found that NextDocs provides a suitable suite of solutions for documentation management and compliance. The suite is designed from the ground up to be used in rigid regulatory environments. Imagine:

• Using email to notify individuals about documents requiring their signature.
• Notification when the document is not signed in a timely manner with automatic "nudges" to the offending individuals.
• No "unrecorded changes" - ever... true tracking capabilities.
• A system that is a simple, cost-effective, web-based solution for tracking documents.
• Security and reliability that allows compliance with FDA 21 CFR Part II.
• Not having to chase everyone down so you can get your work done and go home on time.

NextDocs enhances and configures Microsoft SharePoint Server to provide the necessary compliance functionality. Some of these features include:

• Secure digital signature functionality.
• Detailed document level audits, including version updates, check-in/check-out records, view history, etc.
• User access control and application appropriate security features.
• Workflow management and configurable user-specifics alerts for assigned tasks.

The needs and demands of companies have changed over the last decade when it comes to document management. We hear about the following needs/trends consistently from clients of all sizes:

• The majority of the work in a company today is done with or by individuals outside the traditional employee base. Systems being adopted today must be capable of dealing with this need.
• There is a significant "feature-fatigue" trend. Less is more, and having the right type and level of functionality is critical. Applications that are bloated with features have the inverse effect because companies are unable to train employees.
• Technology must match "the speed of business" - which is accelerating. Multi-year implementations are simply not acceptable.
• Adoption of Microsoft SharePoint in life sciences is very strong. DSGi provides clients an out-of-the-box product that allows them to leverage their investment to meet document management and collaboration needs.

We have found that existing solutions in the marketplace which were designed in the 90's do not match changing needs/trends.

The following suite information outlines the potential of NextDocs and some of the areas where the various disciplines in your facility will be able to comply with new and developing regulations and improved productivity.

Document Management | Compliance Management | Quality Management | Marketing Management

Document Management Features and Associated Benefits

• Document Management is designed to specifically address:
  • Creation, uploading, collection and organizing documents.
  • Set appropriate security and user access control to site content.
  • Quality control and compliance.
  • Document retention policies for record management



• Ease of use:
  • Web based - no desktop installations required
  • Integration with Microsoft Office and PDF
  • Approval & signature workflows
  • Workflow alerts to facilitate document editing, review and approvals through user-specific task assignment
  • Email notification allows user to track workflows and changes to specific documents
  • Tasks & import/export utility
  • Cost effective solution

• Secure:
  • Single sign-on
  • Universal PKI digital signatures provide visible embedded signatures that protect the authenticity of documents and signature.
• Enterprise ready:
  • Track major and minor versions of documents with associated meta data. Restore a previous version as the current version if mistakes are made.
  • Check-in/check-out documents for editing or use the "View" function if no editing is required. Document retention policies ensure duplicate documents are not unintentionally saved or altered.
  • Lifecycle management provides consistency and control.
  • Create efficient and organised document workflows from creation to archival.
• Compliance:
  • View detailed audits.
  • Create reports for document history (See Figure 1).
  • Support for 21 CFR Part 11 compliance built in.
  • Also allows for compliance with GMP, GLP, GCP and other regulations and industry standards.


Detailed Audit Log

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Compliance Management Features and Associated Benefits

The Operations group can easily access standard documentation, protocol and procedures that are current and approved by QA.

• Full feature document, quality and compliance management product suite.
• Integrate document control and management.
• SOP management.
• Employee certification, records and training management.
• Corrective Action / Preventative Action (CAPA) management.
• Integration capability with other systems in the organization.

• A solution that allows information tracking and management.
• Detailed audits and report logs provide visibility into document access and changes.
• Supports 21 CFR Part II.
• Industry leading usability and integration with desktop applications.
• Features universal PKI based digital signatures.
• No desktop validation required.
• Makes use of templates easy.
• Multi-user capability.
• Scalable - web-based.

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Quality Assurance Management Features and Associated Benefits

The Quality Assurance group would benefit from the suite by enhancing existing quality documentation management systems for compliance such as HACCP/HAZOP, Total Quality Management (TQM), SOP's and ISO.

• Enterprise wide process and SOP management
  • Templates
  • Lifecycle management
  • Workflows
  • Publishing
• Employee certification, records and training management
• Corrective Action / Preventative Action (CAPA) management
  • Complaints
  • Observations
  • Deviations
  • Audit findings
• Audits and investigations management
• Exceptions and deviations management
• Project control and documentation management
• Built-in workflows
• Detailed audit logs and reports enable compliance
  • Internal
  • External
• Web portal based with dashboard

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Marketing Management Features and Associated Benefits

• Control promotional material through multi-user web-based applications.
• Obtain digital signatures and approvals through efficient workflows.
• Compliant with 21 CFR Part II.
• Simple and has no desktop installation, saving time and money.

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Contact Us for more information about NextDocs Suite.