Data Integrity & Compliance GxP.......How can you guarantee data integrity and compliance?

I-How do the regulations define Data Integrity?

?? Anyone who has been inspected knows the old adage "what isn't written, didn't happen". The concepts around Data Integrity take this notion even further. The FDA expects data to be attributable, legible, simultaneously recorded, original (or a true copy) and deemed accurate (the famous ALCOA) (1). The FDA also relies on the reliability and accuracy of data, which means that companies must implement strategies to manage risks relating to data integrity.

? An alarming rise in GMP fraud involving data integrity has been highlighted by the FDA.

? The FDA generally encounters problems in the control of paper files that can be easily discarded or lost. Other problems mention the processing of blank forms and the conduct of the audit trail. This is where the use of an electronic Quality Management System, eQMS, comes into its own as a solution for companies wishing to take on board the FDA's suggestions.

II- Support and solutions put in place to deal with the various issues :

?? BIO15PHARMA offers top-of-the-range services in Quality Management, GxP Compliance and is recognised in Transition Management.

?? BIO15PHARMA can offer you electronic Quality Management Systems (eQMS) and support you from A to Z for the implementation of these eQMS which will enable you to comply with the requirements of 21 CFR Part 11 and to digitise :

• ?Quality processes (Documentation, Deviations, CAPAs, Change control, Audits, Training, etc.)
• The cleaning validation system,
• Batch record review and batch certification (electronic batch record),
• Digital visual management system (ePDRCA)
• Supplier management (Supplier Audits and "Commercial Carrying" invoice management)
• And a ZAC decontamination solution. The HDM equipment is QI-QO-QP qualified and meets the requirements of Annex 1 and Data Integrity.

III- Benefits of implementing eQMS :

? By choosing BIO15PHARMA 's services, you benefit from the following advantages:

• Regulatory compliance and compliance with Data Integrity requirements (FDA of 21 CFR Part 11),
• Pass regulatory inspections by reducing the number of discrepancies,
• ?Handle regulatory injunctions quickly and avoid penalties,
• Save several days' production thanks to optimised processes
• Reduce and control sterilisation costs,
• Considerable improvement in productivity and reduction in human error,
• Simplification of quality processes while respecting objectives,
• Reinforcement of health safety and the brand image of industrial sites.

IV- Conclusion :

? The characteristics of reliable data are, in fact, quite simple...:

• Accurate
• Complete
• Accurate at the time of the operation
• Legible
• Original
• Available
• Attributable
• Consistent
• Durable
• Authentic

... but they must be respected in every record and whatever the activity (Production, Quality Control, Logistics, Maintenance, Quality Assurance, R&D , etc.).

? Digitising processes is the main key to continuous improvement of the Quality Management System (QMS).

? Compliance is not an Option, it's a Requirement: The Life Sciences industry is evolving rapidly, and regulatory compliance is more crucial than ever.

V- CTA :

?? Do you need:

? A Data Integrity expert with over 10 years' experience ?

? A digital solution that will enable you to comply with Data Integrity requirements (FDA of 21 CFR Part 11) ?

? BIO15PHARMA can help you by offering qualified, validated eQMS that meet GMP requirements. To contact us and make an appointment, it's simple click here or scan this QR Code below :

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