Projects

To observe client confidentiality, we maintain a strict policy of never releasing client project documentation to third parties. Nor do we publish specific details of client projects.

In general terms, therefore, some of the recent projects we have undertaken include validating:

• A bespoke Product Dossier Manager Web-based system for facilitating Common Technical Document (CTD) submissions across 29 European sites, stored in Documentum Compliance Manager 5.2.5

• The multi-site deployment of a Documentum 4i system in the UK, USA and Japan to facilitate CTD submissions

• A Laboratory Information Management System (LIMS) for a global pharmaceutical company

• Several Microsoft Excel spreadsheets, each using Visual Basic macros and an attached balance, to record active and placebo valve leakage and dose measurements

• Two Microsoft Access databases, for clinical supplies and raw materials inventory

• A Documentum 3 based system with workflows and automatic rendition of PDFs for the Chemical Business Unit of a major pharmaceutical company

• A PC based finished goods inventory system retrospectively for a healthcare company

• A production management information system written in RTL/2 on a VAX/VMS platform

• A semi-automatic ultrasonic well dispense detection system

• A hand-held bar code reader system used for clinical trials

• Various other systems for Y2K compliance

We have also provided independent validation consultancy services (eg electronic records and signatures assessment) to a number of companies as and when required.

Owing to our track record in writing technical documentation, testing validated systems and in the field of document management, since our initial involvement with computer validation in the 1990s, we have also been requested to help on non-validation matters:

• Engaging QA consultancy on a Sarbanes-Oxley project for a global insurer

• Testing of a HM Revenue & Customs payroll system for a major integration testing company

• Providing bespoke document management consultancy for a technical authoring agency

To see about a career with us refer to Careers.

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