Project Definition

SciCord projects can involve a new customer or an extension of the application to a new department within an existing customer.  The effort required is highly project dependent and can range from less than 1 month for an ELN style deployment to more than 1 year for an ELN/LIMS comprehensive/compliant project implementation.  Typical staffing requires:

  • Project lead to provide the overall design and manage customer relations
  • Analyst to obtain customer work process requirements
  • Developer to enhance/create templates and reports
  • Documentation specialist
  • Tester

These roles may be collapsed for smaller implementations.  In addition, an overall project manager is recommended to manage the combined vendor and customer effort.

Roles and Responsibilities

Identify key implementation personnel

  • Department(s)
  • Project owner, lead users, QA, analytical leads, manufacture leads
  • General user population skill levels

Compliance

Identify the level of compliance required and the division of effort between vendor and customer.

  • Research, development, quality control, manufacture
  • SOPs
  • Change controls
  • IQ, OQ, PQ process for core application, templates, and reports
  • Training

Logbooks

Identify the infrastructure required to support analytical or manufacture documentation

  • Instruments
  • Equipment
  • Columns
  • Standards
  • Solutions
  • Chemicals

Integrations

  • Chromatography
  • Instruments
  • External Customers (CRO, CMO)
  • Metrology *
  • Training *
  • Document Management *
  • Methods *

(* use SciCord or external system)

Lifecycles

Verify that the customer can utilize SciCord document and sample lifecycle processes.  Lifecycle processes are defined at the core level requiring a release of the core application in the event the standard lifecycles cannot be used out of the box.

Work Processes

Identify the various analytical and/or manufacture processes which must be supported. Determine if the processes are variations on an existing template/report or will need to be defined/built from scratch.  Provide an implementation cost estimate for the package of revised/new templates & reports.

Samples

Identify requirements for sample types, metadata, naming conventions, label printing, inventory, and interactions with templated processes.

Structured Data

Related to the work process and sample definition, identify the subset of data required for summary reports or to link processes.

Implementation Schedule

Define the implement phases and scope of each phase.  A typical phased approach is to implement the infrastructure (logbooks) first followed by the analytical/batch records.

 

Project Implementation

Overview

As with most applications, implementation work is done in a Test/Training environment.  The production environment is defined once the configuration is accepted by the customer.

The core SciCord application is designed for implementation with minimal configuration.  The application is installed with a default configuration and a set of infrastructure templates.  The vendor defines a lead user in the system who in turn defines additional users, roles, and responsibilities.

The brunt of the implementation effort involves revising or creating new templates which emulate customer work process. Sample types, structured data, and reports are generally associated with one or more templates and are created in tandem with the template(s).

Templates

Templates may be designed tightly coupled to an analytical method or manufacture product.  Templates may also be defined in a more generic way to support an analytical technique or manufacture process. There are of course tradeoffs!  Specific templates are simpler to create, document, and test but quickly proliferate and can become a maintenance issue.  It is also more difficult to react to a new customer methodology since a new template must be commissioned.  Generic templates can be very complex, with definition, documentation, and testing often requiring 3-6 months.  Generic templates also require buy in and compromise among larger groups which can impact delivery and schedule.  Once implemented however, generic templates are more flexible and better support the organization.

SciCord templates are a combination of a spreadsheet component, a configuration file, and a controller.

Spreadsheet

The spreadsheet provides the basic user interface, data entry, calculations, and document level reporting.  Design of the spreadsheet component may be done in most Excel compatible applications, but we recommend using Excel which has a superior tool set.  Most Excel functionality is supported but there are some exceptions such as macros and functionality which is unavailable when a worksheet is protected.

Configuration File

The configuration file is in xml format and defines structured data (analysis, components, sample types, sample attributes …) which are required by the template and provide portability between environments.

Controller

The controller is an assembly which exposes active functionality (buttons, dialogs, events) to enhance spreadsheet operation and can be compared to the Excel Macro language.  In most cases, a standard controller is utilized which provides access to Template API functionality.  In cases where additional (non-generic) functionality is required, a template specific controller may be created using C# (Silverlight).  A template specific controller has access to much of the core application/database providing a wide range of capabilities.

Template API

Template API is an extendable, pluggable library providing at present an automation layer and SciChrom (SciCord’s chromatography interface).  Template API is decoupled from the Core system to allow the addition of new features available to Templates without the need to release new versions of SciCord.

Both automation and SciChrom functionality may be implemented in a template by addition of worksheets to the template containing a proprietary configuration mechanism.

Reports

A report module is a DLL that wraps both the data-access logic (including the run-time parametrization interface) and the report definition – using the standard Microsoft RDLC file format.  Reports are developed and built using Visual Studio and then deployed on the server using a dedicated area in the Portal web application.



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