SOP and Compliance Management

Compliance

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Relationships

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Audit Trails

Reviews

Policies and Procedures

Learn about the foundation of SOPs and Compliance

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Compliance Tracking

The built in Compliance capabilities of DocTract allows published documents to be automatically distributed to the proper audience and record an acknowledgement by employees that they have read and understand a Policy or SOP.  Electronic signature enforcement locks in compliance to meet Regulatory Requirements.

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Electronic Signatures

Electronic signatures are a critical capability in many Regulated environments.  Meet the needs of common Regulatory requirements such as,  21 CFR Part 11 for Life Sciences.  DocTract can enforce confirmation of credentials and password at the time of committing key data to the system.  This includes, record changes, approvals and acknowledgement of understanding for an SOP.

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Revision and Version Control

Track unlimited versions and revisions for Policies, Procedures and other documents.  Track every detail about a Policy, Procedure or other document between versions and access historical versions easily.  Even track changes and feedback from one version to the next, providing a path for the evolution of a document.

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Regulatory and Relationship Tracking

Policies and SOPs do not exist in isolation.  Build an information network between your documents and the regulated environment.

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Related Documents

Your policies and procedures form a connected ecosystem that creates your compliance framework.  Since everything is connected in some fashion, changing a policy, procedure, SOP or other key document can impact other documents.  The built-in Related Document capabilities in DocTract provides quick and easy visibility across all documents that could be impacted from a change.

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Regulation Tracking

The world is always changing, and changes in Regulations or Industry Standards can have minimal, material or no impact on your organization.  The impact of a change in Regulation or Standards needs to go through a thoughtful analysis to understand the impact and potential changes.  The first step in this process is understanding which policies, procedures or SOPs fall under the change.  DocTract provides easy association of Regulations or Standards to your key documents, enabling quick retrieval for an impact analysis.

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Audit Trail

Track who, what and when.  A true audit trail is available throughout DocTract.  This includes tracking not just who and when something was modified, but also the old value and new value after the change.  The high level of audit capabilities provides the compliance needed in a Regulated environment without users even noticing it is there.

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Review and Approval History

DocTract provides a full history and audit trail for all reviews and approvals.  History is tracked by both document and version.  Authorized users can view the feedback, comments and questions provided during the  approval process, including any responses.  The built-in Global Search capabilities can even be activated to search through all of the history of document and not just the current version.

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Document Reviews and Renewals

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Review Reminders

Key compliance documents can either be automatically or manually assigned individual expiration dates.  When a  document is within the Review period defined by your organization, an automatic notification is trigger to the document owner that a review is pending.  Document owners can view their outstanding document reviews in an easy to use dashboard and dedicated interface.

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Review Process

Complete recurring document reviews easily through the automated Review workflow.  Submit expiring documents into the full configurable workflow, track approvals and published fully reviewed documents.  Individual document reviews can be managed from your dashboard to see who has approved and who has not.

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