Lung Rx, a biotechnology company focused on advancing pulmonary medicine,
adopted the EMC® Documentum®/Documentum Compliance Manager platform in 2007 to
meet their content management needs, but had yet to deploy the platform.
Lung Rx had been dependant upon both an internal, shared network as well as
outsourcing solutions to manage their SOP (Standard Operating Procedure) content
and regulatory submissions respectively. Specific to regulatory submissions and
in alignment with the industry, the company also needed to put a system in place
in order to manage electronic submissions to regulatory agencies (as opposed to
traditional paper submissions). And, an end-to-end solution, including
implementation of new infrastructure, needed to be put in place for Lung Rx – in
a short timeframe.
Project objectives for the new system implementation
included:
- Facilitate coordination of end users between the U.S.
and the U.K.
- Effectively manage their SOPs and regulatory
submission documents, while at the same time, staying compliant with relevant
regulatory requirements.
- Ensure that current versions of critical
documents/procedures are being disseminated company-wide at any given point.
- Expedite their ability to compile and submit
electronic applications/updates to regulatory agencies.
- Implement an industry best-practice validated system, quickly.
Lung Rx engaged Impact Systems to identify the approach, deliverables and
services that would best meet these enterprise content management needs. Through
the course of the initial meetings to establish high level requirements, the
team determined that Lung Rx’s requirements were extremely close to two
pre-configured solutions developed by Impact Systems and EMC Documentum,
Compliance-in-a-Box (CiB) SOP Edition and Compliance-in-a- Box Submission
Edition. LungRx agreed to pursue this deployment option, which would provide a
much quicker implementation period at a more affordable price than a traditional
deployment.
Lung Rx was confident that CiB would withstand their compliance requirements,
since CiB is a proven, best-practice enterprise application in the
heavily-regulated life sciences industry. And, Lung Rx knew that CiB was
developed specifically for mid-market organizations in need of enterprise
content management systems for controlled content. Hence, LungRx felt good about
working with Impact Systems, as they knew Impact understood their small-company
mindset.
Additionally, Lung Rx agreed to deploy the latest Documentum Compliance
Manager (DCM) release, 6.5, which meant they would be one of the first companies
to deploy 6.5 and take advantage of the latest features and functionality
offered via DCM 6.5.
Built on top of the EMC® Documentum® Enterprise Compliance Platform,
Compliance- in-a-Box SOP Edition is based on EMC Documentum Compliance Manager
(DCM) configured for SOP work processes and management, and Compliance-in-a- Box
Submission Edition provides a turnkey solution for electronic submissions. Both
are backed by Impact’s consulting services, pre-configuration tools, templates,
and document types. The result is a fully functioning, validated Documentum
Compliance environment that is content-ready.
Also attractive to Lung Rx was the CiB philosophy – start
small, with the ability to scale quickly and at the same time, have the ability
to “think big” with respect to a long-term enterprise solution. CiB allowed Lung
Rx to get a working EMC® Documentum®
application up and running within eight weeks from
installation in a test environment through implementation in the production
environment, including validation. The use of this pre-defined solution with a
tightly controlled project scope and set of configurations plus associated
validation scripts would provide results in a condensed time frame, and prepare
Lung Rx with a solid foundation of compliance infrastructure for extended use of
Documentum.
Also important to Lung Rx were the features and functionality provided by EMC
Documentum Compliance Manager (DCM). The platform replaces manual processes with
an automated, integrated, online environment for creating, reviewing, revising,
approving, distributing and auditing controlled content. DCM dramatically
reduces the time and effort spent managing controlled content.
DCM audits all controlled content activities, and enables all users,
managers, and external agencies to know when and why changes were made. And by
helping Lung Rx meet quality objectives and comply with internal and external
regulations and standards, DCM reduces company operating costs; minimizes waste,
errors, and production delays; and may likely allow LungRx to deliver products
to market faster.
Specifically, DCM allows Lung Rx to:
- Easily respond to external regulatory agencies
- Quickly determine who has interacted with content, as
well as when and why
- Detect attempts to alter or remove documents
- Enforce signatures and proper approvals
- Ensure content authenticity and immutability
- Ensure document retention for required periods
An end-to-end solution, including implementation of new infrastructure, was
executed for Lung Rx. As a result of the implementation, a best practice SOP
Management Process was adapted by LungRx. It took eight weeks to achieve the
company’s initial objectives of deploying EMC Documentum pre-configured for SOP
Management and eCTD Submissions. The company now has their first Food and Drug
Administration's FDA 21CFR Part 11 validated system, which they can scale
according to their future needs, and the following objectives were achieved:
- Collaboration. The CiB solution ensures that all
staff, both in the U.S. and the U.K., can collaborate and efficiently manage
controlled content across the organization.
- Risk mitigation. The company can now be sure that
current documents and procedures are being disseminated across the LungRx
organization at any given point.
- Organizational efficiency. The company now has a
system that allows them to much more efficiently manage controlled content.
- Increased compliance. Lung Rx now has a 21 CFR Part
11 validated system.
- Organizational adoption. Lung Rx used Impact System’s
Operational Qualification scripts to train their team internally, and the
company has been very pleased with internal acceptance of the system.
- Efficiency gains. Lung Rx now has the ability to
manage their submissions to regulatory agencies.
- Cost and time savings. The rapid CiB installation and implementation
provided significant cost savings, and reduced Lung Rx IT staff involvement.
Compliance-in-a-Box reduced the implementation period by 60 percent over that
of a traditional deployment, saving Lung Rx significant time and money. The
solution was implemented in eight weeks, compared to a traditional deployment
period of four to six months for a regulatory compliant system.
Lung Rx, as a biotechnology company, is ultimately in the business of helping
patients. The hope is that this solution will be of significant assistance in
allowing Lung Rx to make their pulmonary products available to the marketplace
earlier than would have been possible prior to this solution being in
place.