Electronic Document Management System (EDMS)

Ensure your Electronic Document, Quality, and Training Management System is cost-efficient, effective, and compliant

Electronic Document Management System (EDMS)

Ensure your Electronic Document, Quality, and Training Management System is
cost-efficient, effective, and compliant

We provide effective, efficient, and compliant EDMS+QMS and training solutions

A well-functioning Electronic Document, Quality, and Training Management system is one of the cores of any pharma company. Pharma IT consultants are specialists within the pharma, biotech and medical device industries, and possess deep insight into sector specific IT applications. We can assist you with a tailored solution to meet your needs.

We provide effective, efficient, and compliant EDMS+QMS and training solutions

A well-functioning Electronic Document, Quality, and Training Management system is one of the cores of any Pharma Company. Pharma IT consultants are specialists within the pharma, biotech and medical device industries, and possess deep insight into sector specific IT applications. We can assist you with a tailored solution to meet your needs.

Our EDMS+QMS offerings span four consultancy areas



Strategy

Scoping

Clarification of documents and processes to include in project and proposed phasing

Business case on implementation (optional)



RfP/Vendor Selection

Vendor Demos

Vendor Evaluation and Request for Proposal

Vendor selection

Negotiation and Contract management



Implementation

Project Management

Process and SME expertise

Quality Planning

Specification, Configuration and Construction with Vendor

Qualification/Validation

Preparation for Go-Live



Maintenance

System Maintenance and Support

Training

Change Control

System Life Cycle Management

Pharma IT Cloud EDMS+QMS is our full-service, in-house solution

The Pharma IT Cloud EDMS+QMS is a complete GxP-validated Document, Quality, and Training Management system based on Ennov software, and pre-configured according to industry best practices. Our cost-effective solution boasts zero upfront implementation costs and comes with the support of Pharma IT’s expert consultants.

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 our expertise to ensure efficiency and compliance

We have helped companies of all sizes find, establish, and maintain the right EDMS+QMS to meet their needs. Pharma IT is technology agnostic and works with various EDMS platforms, and can guide you in selecting the right fit for you. With our support, you can rest assured that you are utilizing the most cost-effective, efficient, and compliant solution for your firm.

Jakob Juul Rasmussen, Managing Director

JakobJuulRasmussen

Our EDMS+QMS offerings span four consultancy areas



Strategy

• Scoping

• Clarification of documents and processes to include in project and proposed phasing

• Business case on implementation (optional)



RfP/Vendor Selection

• Vendor Demos

• Vendor Evaluation and Request for Proposal

• Vendor selection

• Negotiation and Contract management



Implementation

• Project Management

• Process and SME expertise

• Quality Planning

• Specification, Configuration and Construction with Vendor

• Qualification/Validation

• Preparation for Go-Live



Maintenance

• System Maintenance and Support

• Training

• Change Control

• System Life Cycle Management

Pharma IT Cloud EDMS+QMS is our full-service, in-house solution

The Pharma IT Cloud EDMS+QMS is a complete GxP-validated Document, Quality, and Training Management system based on Ennov software, and pre-configured according to industry best practices. Our cost-effective solution boasts zero upfront implementation costs and comes with the support of Pharma IT’s expert consultants.

Harness our expertise to ensure efficiency and compliance

We have helped companies of all sizes find, establish, and maintain the right EDMS+QMS to meet their needs. Pharma IT is technology agnostic and works with various EDMS platforms, and can guide you in selecting the right fit for you. With our support, you can rest assured that you are utilizing the most cost-effective, efficient, and compliant solution for your firm.

Jakob Juul Rasmussen, Managing Director

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
EDMS+QMS offerings?

We offer strategy, vendor selection, implementation, and maintenance services

Are you interested in learning more about our EDMS+QMS offerings?

We offer strategy, vendor selection, implementation, and maintenance services