Excel Spreadsheets are an essential tool for supporting GMP business processes. By establishing a well managed program for assessment, design and qualfication, spreadsheets can provide a robust and compliant system for a wide range of GMP and non-GMP tasks, including result calculation, stability planning, inventory tracking and risk management.
Spreadsheets provide an excellent means for users to develop and prototype business processes, that might later become part of a more bespoke application, or can themselves remain a means to acheiving a compliant solution. As a regulated company, management has to balance the flexibility that spreadsheets provide with ensuring a compliant, robust and integral solution is maintained.
Common problems encountered include:
- Lack of visibility by senior management, IT or QA of the types and numbers of spreadsheets in use in an organisation
- Use of unvalidated and uncontrolled spreadsheets for GMP applications
- Lack of planning and risk management for spreadsheets and their use
- Poorly designed, and fundamentally incorrect, implementations of calculations in Excel.
TRAQuE provides a comprehensive Excel Spreadsheet Validation service, that can be tailored to suit your organisations needs. This can include:
- Implementation of a QMS, procedures and training to manage the design, validation and maintenance of Excel spreadsheets in the organisation
- Standardised risk assessment methodology for assessing GMP criticality of spreadsheets and the data they maintain or produce
- A complete design, development, testing and validation service for spreadsheets, tailored to your organisation's needs
- Customised function and macro development and testing to extend the stardard Excel functionality
To discuss your requirements further, or find out more, please Contact Us for more details