MS-Access Database Compliance
ABB Engineering Services – Life Sciences has a successful track record of working with blue-chip pharmaceutical clients to install and validate MS-Access based systems in compliance with the latest industry regulations and practices. We work closely with key users of the systems to ensure rapid implementation in the minimum timeframe. Our approach enables companies to continue to utilise their existing investment in MS-Office based IT solutions and avoids the necessity of purchasing expensive additional software/hardware.
Project Management
ABB can supply their extensive PM expertise to mitigate project risk and ensure on-time delivery. The project may be managed as a ‘simple’ standalone database validation; it could be combined with other Access database system validations, or can be part of a wider/corporate project. A key feature of ABB’s project management approach is their ability to integrate with other partners to ensure the highest performance levels throughout the team.
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System Design / Customisation / Optimisation
Typically we find that some optimisation is necessary to client databases prior to the addition of any necessary technical controls. If required we can extend the “technical” optimisation service to review and improve the business process surrounding the database; additionally our expertise can be applied to enhance and customise the database to support any new requirements. ABB have a library of generic solutions at our fingertips, we can supply a complete solution for your requirements even if you have no existing database in operation.
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Database Technical Controls
In order to meet regulatory requirements it often necessary to add technical controls to existing MS Access databases. ABB work in partnership with a number of companies who can supply technical controls for the following:
- Security – Unique login ID’s, enhanced password security.
- Integrity – Full/configurable audit trails & event logging.
- Electronic Signatures – Configurable signature meanings, passwords and record locking.
- Database Analysis - Comprehensive relationship determination and categorisation
- Search Engine– Secure viewer and customized reports
We also have experience of working with other third party add-ins and control systems for databases and can readily adapt our generic solutions to these systems.
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System Validation
ABB Engineering Services are the world leader in computer systems validation, as exemplified by our leading roles in the GAMP forum. We have developed a generic document set, based on the highly acclaimed spreadsheet validation documents, to facilitate the validation of MS-Access databases. These documents provide User and Functional Specifications, together with Qualification documentation for the final system. We can supply these documents as generic templates, together with any required training, or provide a full validation service.
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System Implementation
ABB will work alongside your users and IT departments to ensure the final system is implemented in a compliant manner. We have wide experience in the supply of data migration testing/reports, User training and SOP’s, system acceptance reports etc. A key feature of our service is our flexibility to meet your individual requirements in a cost-effective manner.
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System Support
ABB’s ‘Validation’ services do not stop once the system is installed, we can continue to support your system throughout its lifecycle. We can offer our services to assist in areas such as troubleshooting, performance monitoring, data archiving, change control and eventual system retirement. Consider ABB as your representative in the regulatory arena in addressing your regulatory and validation issues, or as a partner for validation outsourcing.
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