We’re T-2 weeks for MOMENTUM’16. As we approach the conference, we’re shining the spotlight on the innovative people and organizations that make MOMENTUM’16 possible. Today we’re featuring insights on the cloud from David Blewitt, Vice President of Cloud Compliance Services and Solutions for USDM Life Sciences: 

The past 12 months have seen a significant number of Life Sciences companies adopting the functionality and advantages offered by the Cloud to perform many of their key regulatory functions.

Not least of these is the adoption of the DocuSign solution for 21CFR Part 11 Compliant Electronic Signatures – embedded within various business processes, areas and client specific use cases.

As DocuSign’s regulatory compliance partner, USDM Life Sciences and DocuSign worked together to develop the part 11 solution, following which USDM developed a suite of Validation Accelerators to enable Life Sciences companies to accomplish key goals, such as:

  • Satisfying the compliance departments within each company that the Part 11 solution meets all of the requirements of the related regulations and can be validated, controlled and maintained in a constantly compliant state.
  • Significantly reduce both the monetary and chronological cost of implementing the solution (average implementation and validation effort is just five weeks).

In the past year alone we have enabled more than 15 Life Sciences companies to go live. After selecting the Part 11 solution and USDM’s Validation Accelerator Services, the effort for each of these companies to maintain their solutions in a state of compliance is now being handled by USDM’s maintenance packages and monthly Validation and Verification Protocols.

Clients range in size from small businesses with no or very small regulatory departments, to Global Pharmaceutical and Medical Device companies with thousands of users and large regulatory capacity.

New Releases and fixes issued by DocuSign on a monthly basis are analyzed according to their inherent complexity and area of focus, and appropriate mitigating actions are then taken to ensure the compliant state is maintained. This process can be handled entirely by USDM, by the client, or by a combination of both — depending on the needs and desires of the end users.

As with any line of business, trust is a key factor, and it is especially important with SaaS. DocuSign, as the Vendor of SaaS solutions to the Life Sciences sector, has a responsibility for some of the key compliance elements when it comes to the overall systems validation and qualification picture.

Establishment of a Quality Management system, encompassing things like installation qualification processes, data center qualifications, back-up and recovery/business continuity processes, release management, communications processes and change control is critical in demonstrating the commitment to compliance that DocuSign has undertaken. USDM performs an annual audit of DocuSign to ensure their processes and compliance effort remains at the pinnacle of where it needs to be for their clients.

Selecting DocuSign for your Part 11 solution – whether it be as a standalone system, or integrated to other systems within or outside the cloud space – such as EDMS, CRM, ERP, CRO. LIMS, Test Automation or any number of bespoke systems, with USDM as the compliance partner, it can enable you to open up a world of efficiency and compliance that was not available in the past.

Regulatory departments within companies that have adopted the solution are now being asked on a very regular basis by their own internal departments how they can adopt the solution for other use cases. DocuSign is very adaptable and through numerous standard API’s can integrate into these other systems. And working together, USDM and DocuSign have and can enable establishment of new business processes to grab the opportunity to see the Silver Lining in the Cloud.

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