Document Pipeline - Migration & Import Tool
Our role was to design and implement a document migration and import tool - known
as "dPipeline" - to allow our Pharma client to send documents to their regulatory
content management system from a range of remote applications.
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The dPipeline application allows our client to construct document processing
"pipelines", so that when documents and metadata are sent from remote systems
they are loaded into the content management system according to highly-configurable
business rules.
The application consists of a library of reuseable operations that might be
performed during the import of a document - for example, applying a business policy -
together with a user-configurable architecture for defining which of these
operations should apply to a given class of incoming document, and in what order they
should be applied.
dPipeline is a 24/7 background application, ensuring that incoming documents
are processed as soon as they are generated by their source systems, and with
zero manual intervention.
We implemented the application using Java and XML/XSL, to ensure maximum
portability across our client's UNIX and Windows operating environments.
Regulatory Content Management
Our client - a global pharma - leads the sector in their exploitation
of Documentum for regulatory content management. We were engaged as client
technical architect for the latest version of their in-house application.
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The application facilitates the authoring and lifecycle management of
pharmaceutical regulatory content and is available to 6000 users worldwide.
Our main responsibilities were: defining and implementing the technical
architecture and detailed design for the application; consulting on technical
architecture matters to the development team; provision of the programming
resource for many of the major components of the application.
The application server architecture is based on a distributed configuration
of Documentum. The client architecture is based on an XML and DFC data
access layer, middle-tier COM and Java-based components, and a Visual
Basic presentation layer making extensive use of XSL transformations and
ActiveX controls. The application is deployed to a global user base using
a thin-client architecture based on Windows 2000 Terminal Services and
Citrix Metaframe XP.
The new version of the application affords high levels of productivity
in comparison to the earlier web-based client, due to its intuitive and
powerful user interface. For example, a major failing of the earlier client
- overcome in the new release - was its inability to perform a single
operation on a number of objects simultaneously.
It is also highly configurable as the majority of its control mechanisms
are XML-based. This allows major alterations to application functionality
- for example, the availability of entire features - to be made without
the need to rebuild and validate the application. It is also extensible,
as newly-developed components may be added to the application purely by
a modification to the XML-based configuration.
Research & Development Records Management
We were engaged to assist in the implementation of a document imaging
and management system within the Research & Development Records Centre
of a major international pharmaceuticals company.
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The primary objective of the department was to provide faster access
to GxP documentation held within the Records Centre to research scientists
within the R&D function. The first phase of the project was to implement
and validate a scalable document imaging system based on Kofax Ascent
Capture and Documentum. The second phase was to enable access to the information
via the corporate intranet using Documentum RightSite and an application
based on Viewspace.
We have since returned to migrate the entire system to a new server architecture
based on Documentum 4.2 and a new client application based on Documentum
Intranet Client.
Chemistry & Pharmacy Dossier Management
Implementation of a document management system within the International
Manufacturing department of a major international pharmaceuticals company.
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The primary objective of the department was to centralise the storage
and control of the Chemistry & Pharmacy Dossier, a major component
of each new drug application submitted to the regulatory authorities.
Following regulatory approval, this document continues to evolve during
the life cycle of a drug and each element of the document develops multiple
variants based on the markets into which a drug will be sold and the sites
where it will be manufactured. Total accuracy in managing the configuration
of the document is essential to ensure regulatory compliance in each market
where a drug is approved.
A solution was implemented based on Microsoft development tools and Documentum
EDMS. In addition to the main application, a tool was developed for browsing
and viewing off-line documentation packages that were published by the
system onto optical disk for distribution to remote manufacturing sites.
Thin-Client Application Architecture Design
Our client - a global pharma - had a requirement to migrate two major
legacy applications to a server-based model. The applications were no
longer compatible with the company's strategic desktop. We were engaged
to design and implement thin-client architectures for the two applications,
to allow them to continue to be available post-rollout of the new desktop.
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Working with the application vendors, we designed and scaled a server-based
deployment appropriate to the client's needs. The server architectures
were based on Windows Terminal Services and Citrix Metaframe. In addition
to the application design role, we were responsible for the specification,
installation and configuration of the server hardware required to support
the applications. To meet the client's regulatory requirements, we were
also directly involved in planning and executing the necessary qualifications.
Litigation Support Document Management
We were engaged to carry out a detailed analysis of an existing document
management system in use within the Legal department of a major UK-based
public sector energy company.
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Our client had highlighted a number of operational issues and the objective
of the project was to identify any specific technical or procedural problems
present in the system and to propose a remedial course of action. During
the course of the project this remit was extended to incorporate a more
strategic assessment of the document management needs of the Legal function.
After a period of analysis and consultation, a number of key issues regarding
performance and functionality were presented to the client together with
a set of phased options supported by detailed cost/benefit data. A number
of high-priority remedies were recommended and subsequently undertaken
in order to maintain the short-term viability of the system.
Legal Affairs Document Management
Implementation of a document management system within the Legal Affairs
department of a major international pharmaceuticals company.
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The primary objectives of the department were to reduce the volume of
paper documents required to be on hand at any time, and to improve the
ability to quickly retrieve documents relevant to a subject area (for
example in support of the document discovery process in litigation). There
were also benefits to be gained in streamlining and standardising the
department's processes for creating electronic documents.
A particular requirement of the project was for the system to be developed
and implemented within the framework of PD0008: the Code of Practice for
the Legal Admissibility and Evidential Weight of Information Stored Electronically.
Workshops were held to assist the clients in identifying their requirements
and to gain commitment to the process. From these a user requirements
specification, technical architecture and functional specification were
produced. A detailed design based on Documentum and Kofax Ascent imaging
tools was implemented. Visual Basic scripts were written to migrate an existing
PC-based document index into Documentum. The project was concluded by phases of
system testing, acceptance testing, implementation, data migration and user
training.
Investment Research Management
Implementation of a document imaging and management system for 1998 world-leading
hedge fund and Micropal award winner Bayard Partners Ltd.
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The purpose of the system was to manage key investment research information
gathered by the firm's research analysts. A primary benefit was the ability
to sort and filter the information easily and efficiently to provide effective
support to the investment decision-making process.
A Documentum-based solution was developed that was accessible from both
the company intranet and from ODMA-enabled desktop applications. Information
arriving from a variety of sources is handled, including paper, internally
and externally created electronic documents, electronic trading systems
and the internet. The solution incorporates extensive search facilities
covering both document metadata and content - for example, searches may
be executed simultaneously across the docbase and a range of internet
search engines. An integrated document imaging system was provided based
on Documentum DocInput. The system incorporates a gateway between Documentum
and leading hedge fund management package Tradar Portfolio.
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