How can you guarantee accurate GMP data entry and reporting?

Computerised systems should be validated and under a periodic re-validation program in accordance to guidances such as Annex 11. A robust system to implement ALCOA+ principles should ensure data accuracy at all levels of the work environment.

One thing I have found helpful is to have a system to put evidence as pictures that each step is done. Actually there should be two entries from the performers and auditors as well.

It is imperative to understand GAMP 5 principles and to properly assess if ANY changes or modifications made to a system in any way take this from COTS to customised. The validation plan has to account for these customisations so a thorough understanding of the URS to implementing is needed from the outset. Linking equipment URS to include capacity to provide data integrations means your IT / Tech function needs to be involved from the start. even if integration is needed in the future it is sensible forward business planning and saves on capex rather than needing manual workabouts or risky human interventions. Where does the system owner responsibility lie and why?

Do not forget when updating systems to assess backwards compatibility for historic data … this has to be a detailed assessment from the IT support functions Where will data reside and have you considered Data Protection policies as well?

Actually one of the requirements before implementing is to show the performers, auditors how they can fit and take from them evidence what they have learned..and they can see themselves in the organisation mission

The training program should also be included as part of the internal audit (self inspection) program. This should also include a list of trained auditors across the business and an established retraining frequency in particular for the GMP aspect (a defined GMP refresher program). Where possible, a “train the trainer” program should be established to ensure the competency of all personnel.

Consider what is a lead and lag KPI and make sure this is risk assessed and part of management monitoring / self inspection programs.

Ensuring precise GMP data entry and reporting is paramount for upholding product quality and compliance in industries like pharmaceuticals and manufacturing. This involves training personnel rigorously, establishing meticulous SOPs, verifying data, utilizing electronic data management systems, and enforcing strict access controls. Real-time entry, error correction protocols, and regular audits further enhance accuracy. Cultivating a culture of data integrity reinforces the significance of honest and accurate reporting. For instance, in pharmaceuticals, adhering to GMP guidelines entails accurately recording ingredient quantities, processing times, equipment calibration records, and deviations, if any, fostering airtight quality assurance.