Products

Validation Accelerator Packages

Life science companies must manage global compliance standards and accelerating performance expectations to maintain a competitive advantage in the industry. Companies are looking to decrease costs, accelerate time to market, increase productivity, while achieving, simplifying and maintaining compliance.

Oakston technologies Life Sciences practise provides a comprehensive enterprise solution to support US, EMEA, and Asian regulatory requirements for regulated applications (see list below).

This practice provides Validation Accelerator Packs (VAPs) and compliance methodology provides life science companies with an industry best practice tool to simplify compliance, increase productivity and minimize costs. VAPs have been used successfully in the industry for more than a decade.

VAPs are a complete set of validation document templates for each based on common, general requirements for life science companies and contain the following compliance documentation:

Computer System Validation Plan

• Risk Assessment
• Business Requirements Model
• System Requirements Specification
• Installation Qualification Package  includes protocol, test scripts and summary report template
• Operational Qualification Package includes protocol, test scripts and summary report template
• Performance Qualification Package includes protocol, test scripts and summary report template
• Traceability Matrix
• Standard Operating Procedure Checklist
• Validation Summary Report

The USDM Life Sciences VAPs can decrease both validation time and validation costs by 60%, as well as provide for faster implementation time and better system performance. The VAPs provide an industry proven best practice approach to validation and compliance.

Extender

Extender is a social crowdsourcing platform for sourcing, creating and sharing spreadsheet models. Users can got to “Extender” and search for spreadsheet models specific to their need, or post requests about their need, other “Extender” users (from all over the world) can then respond to such requests by uploading the required spreadsheet model.

Each spreadsheet is unique, depending on the data being analyzed and the outcome to be inferred. For example, your typical income tax calculation spreadsheet would be vastly different to the one analyzing your mortgage payments, which in turn would be different from a spreadsheet that calculates your student loan interest. In short, every unique situation requires a unique spreadsheet model.

ALM Migrator

ALM Migrator tool allows to migrate the data from any 3rd party (Defect, Requirement, Test Management) tools in to Quality Center along with attachments and Linked Defects.

This tool will Extract,Convert and Upload the data from any 3rd party (DM, TM, RM) Tools.

• Data Extract and Upload Utility interact with most popular databases (like SQL Server, Oracle ,My Sql) to extract the data .
• Base on custom SQL it will convert the data as per client requirements.
• Upload the converted data in to the various version of ALM tool.
• Bulk Attachment upload Utility
• Linked Defects Extract and Upload Utility create links between two defects /tests/requirements in QC as exist in legacy tool.