Full GxP-validation of DocuSign™

Ensure technological and procedural compliance

Full GxP-validation of DocuSign™

A pharma-focused packaged solution that ensures technological and procedural compliance

We can get you started with DocuSign – and ensure full GxP-compliance in the process

Pharma IT’s experienced consultants can help your company stay Part 11 compliant not only from a technological perspective, but also from an internal procedural standpoint. To this end, our solution includes templates, predefined documents and processes to establish the fully GxPcompliant use of DocuSign.

We can get you started with DocuSign – and ensure full GxP-compliance in the process

Pharma IT’s experienced consultants can help your company stay Part 11 compliant not only from a technological perspective, but also from an internal procedural standpoint. To this end, our solution includes templates, predefined documents and processes to establish the fully GxPcompliant use of DocuSign.

Our DocuSign package spans all core validation documentation needs

We offer all core validation documentation as a packaged solution including: 

  • Vendor Assessment
  • GxP Assessment
  • Risk Assessment
  • Validation Plan
  • User Requirement Specification
  • Configuration Specification
  • Performance Qualification & Traceability
  • Validation Report
  • System Administrator Manual
  • System User SOP

Our DocuSign package spans all core validation documentation needs

We offer all core validation documentation as a packaged solution including: 

  • Vendor Assessment
  • GxP Assessment
  • Risk Assessment
  • Validation Plan
  • User Requirement Specification
  • Configuration Specification
  • Performance Qualification & Traceability
  • Validation Report
  • System Administrator Manual
  • System User SOP

Our DocuSign package spans all core validation documentation needs

We offer all core validation documentation as a packaged solution including, but not limited to: GxP and Risk Assessments, Performance Qualifications & Traceability, Validation Reports, and System User SOP. In this way, we ensure that your DocuSign solution includes all the necessary documentation for remaining compliant now and in the future. 

Harness the Cloud to ensure long-term Part 11 compliance

Although DocuSign is an excellent cost-effective tool to provide functionality related to electronic signatures for both GxP and non-GxP documents, clients may find that its use as a long-term document archive is limited. To this end, Pharma IT’s Cloud EDMS includes fully compliant archiving features for long-term storage. 

Harness the Cloud to ensure long-term Part 11 compliance

Although DocuSign is an excellent cost-effective tool to provide functionality related to electronic signatures for both GxP and non-GxP documents, clients may find that its use as a long-term document archive is limited. To this end, Pharma IT’s Cloud EDMS includes fully compliant archiving features for long-term storage. 

We can get you started with automation immediately

Our team can ensure that your company remains Part 11 compliant through our Full Validation of DocuSign solution. If your firm needs extended functionality for regulatory document writing, Pharma IT also offers our Pharma IT Cloud service: a unique cloud offering in the market created specifically with smaller firms in the pharma, biotech and medical device industries in mind.

Jakob Juul Rasmussen, Managing Director

Are you interested in learning more about our DocuSign offering?

We offer full GxP-validation, Cloud-based long-term archiving, and more

Are you interested in learning more about our DocuSign offering?

We offer full GxP-validation, Cloud-based long-term archiving, and more