For the administration of production equipment, recording and graphical presentation of clean room monitoring data or for conducting statistical analyses in quality assurance: many of these quality-related tasks are performed with EXCEL® spreadsheets today.
But watch out! When the activities are related to products subject to GMP requirements, the spreadsheets being used require validation and quickly draw the attention of inspectors and auditors. Then the regulatory requirements must be met reliably while the effort is kept within limits.
Categorising and Reducing Effort
Not all Excel spreadsheets need to be validated the same way. GxP criticality and complexity are crucial factors. gempex uses a categorisation system developed in-house and derived from the GAMP guideline for the validation of computer-aided systems, and assigns each spreadsheet to a suitable category. Risk-based and according to the application. An appropriate validation approach is assigned to each category. This helps maintain an overview and keeps the effort low.
Reliable Implementation of GMP Compliance Requirements
Since the rules and guidelines generally demand certain security functions for computer-aided systems, these also have to be implemented in Excel spreadsheets. They include protection of non-editable content, verification functions for input cells with warnings and error messages, and an audit trail that cannot be manipulated. Implementing these is essential to make spreadsheet validation possible in the first place. gempex is experienced and reliable in this field, using proven functions and macros.
Reliable Excel Validation with Proven Tools
The validation itself is performed with the help of a proven and standardised validation protocol consisting of the parts specification, testing and report. All specification and test points for the validation that was performed are easy to follow within the protocol so the generally required traceability is assured. Through use in a variety of projects, tools like the SOP and validation protocol for Excel validation have been continuously optimised and their application simplified. This results in reliability, provides a good overview and guarantees the required compliance.
Optional: Know-how Transfer and In-house Validation
For those who prefer to conduct the validation in-house, the corresponding tools can be provided along with implementation, adaptation and instruction. Here gempex demonstrates full flexibility as a service provider. Then a streamlined process according to the requirements is developed jointly with the customer and clearly described in a concept SOP. This includes responsibilities, forms and the directly usable validation protocol. Employee training is a matter of course for gempex, by request also coaching with an initial spreadsheet. This quasi constitutes the comprehensive transfer of know-how with all required tools.
Reliable Excel validation – doing the right thing with know-how and experience.
- structured, fast determination of the required validation effort
- clear approach that is easy to communicate internally and externally to authorities
- experience and routine in the integration of compliance functions
- efficiency through the use of proven macros and standardised tools
- specification, testing and reporting in one document with a clear layout
- traceability, compliance and inspection reliability
- support to meet customer's needs – as a service or for internal use