Why is Data Integrity Training important?

How we generate, maintain and store records, particularly paper and electronic mediums now and in the future is extremely important.

Maintaining Data Integrity by having bonafide Data Integrity Training, forms part of your Quality Management System. Any omissions, lost or incorrect record keeping, will be picked up by inspectors and will be counted against you. If it’s serious enough, temporary suspensions can be incurred in the event of a serious deviation from procedure.

To have Data Integrity is to have adequate assurance that documents, records and data, remain secure, accessible and unaltered until their expiry date. Every detail of what goes on in the premises where GDP activity is concerned, must be documented, dated and signed. This even includes basic contract cleaning services.

“if it’s not written down, it’s just a rumour”.

Consequences of poor Data Integrity

Compromised, lost or absent data – whichever the format – is not only useless to a company, but carries an exponential degree of risk. This is because you would be unable to explain the ‘where’, ‘when’ and ‘who’, of any activity. This is particularly bad if a class 1 recall had to be made due to an alert sent to the DMRC (Defective Medicines Report Centre), where there was a serious risk to patients’ health reported.

If you were part of the supply chain for that product, and you could not demonstrate your actions because of insufficient or absent data, your license will be at risk. A suspension of your WDA License is likely, pending an investigation. Inspectors and auditors will presume that if it’s not written down, then it either did not happen, or you have removed the data. In this case, they may suspect illegal/criminal activity.

Doing it Right

By getting Data Integrity Training, thus following the SOPs and engaging the procedures for data integrity correctly, you achieve several things:

~ Compliance with GDP
~ Transparency for all stock movements and transactions
~ The Quality Management System is supported
~ Ability to respond rapidly and promptly in the event of recalls or deviations
~ Software systems are used correctly and statistically less likely to break down
~ Errors and evidence of Falsified Medicinal Products more easily spotted
~ Reassurance of satisfactory audits where documentation and data is concerned
~ Prevention of unexplainable stock audit and document/data abberations

Data Integrity Training

Paradigm Shift Consulting have a comprehensive training platform, which includes a course specifically for Data Integrity Training. The course is clearly laid out and well priced; even start-up businesses with low staff number can afford to take it. Successfully completing the course will produce a certificate presentable to inspectors as evidence of training, valid for 12 months.

Everything that Paradigm Shift Consulting does, is designed to help you do your job correctly and in a way that is with GDP compliance. We never “take the money and run”. However, if we can see you heading into dark and dangerous waters, we will advise you to stop what you are doing, and do everything we can to steer you away from (very expensive) trouble.

We want to see your business work in the interest of patient safety and product quality.

Get In Touch

Are you having repeated difficulty interpreting your own data? Are details of transactions getting lost? Are there aberrations and contradictions of dates and data showing up too often? Or perhaps your staff are not actually trained, which is a serious problem when inspection occurs? If you’re just getting started, train your staff immediately, as you cannot have staff engage their tasks without initial certificated GDP training (EU GDP Guidelines 2013/C 343/01, Ch2.4, para 1).

You can call us anytime between 9am and 5.30pm GMT for advice, or contact us with your enquiry using the form below, quoting “data integrity training” in your message.