Data integrity is fundamental in many of the industries The Hark Platform is being utilised in.
But by far the most heavily regulated industry is pharmaceuticals and life sciences.
The industry governing body, the MHRA set out these guidelines within their MHRA GMP Data Integrity Definitions and Guidance for Industry when describing how to design systems to assure data quality and integrity:
Systems should be designed in a way that encourages compliance with the principles of data integrity.
Examples include:
- Access to clocks for recording timed events
- Accessibility of batch records at locations where activities take place so that ad hoc datarecording and later transcription to official records is not necessary
- Control over blank paper templates for data recordingUser access rights which prevent (or audit trail) data amendments
- Automated data capture or printers attached to equipment such as balances
- Proximity of printers to relevant activities
- Access to sampling points (e.g. for water systems)
- Access to raw data for staff performing data checking activities
With the above being one of the many stringent rules that hold the industry accountable for its products, justifying the use of a non-smart system is becoming much harder to do.
Monitoring your temperature and humidity in testing, storage and production facilities will soon be fully automated and this time of the year should bring updating considerations to the fore.
Although most companies that need to monitor and store environmental data have moved to at least digital monitoring systems, the addition of a smart system can drastically change how data integrity is ensured.
Case in point, on the 29th of October British Summer Time ends and at 1am on the 30th of October, our clocks will turn back to 00.00. A non-smart system may not be able to handle this change, or carry on as if it didn’t happen which in actually means the data you are storing is not accurate or questionable at best.
To ensure trustworthiness and reliability of electronic records the accuracy of the time stamp applied is vital and the means of checking and setting the accuracy of the time stamp is of critical importance.
Ideally time should be checked automatically via a network and it needs to be accurate within a minute. As per the FDA’s requirements, your time stamp should be local to the user and the sample in question.
Daylight savings time brings one of many potential issues that can occur with a local system whether it’s local to the storage chamber itself or local to the facility as a whole, i.e. in a local server. With a smart system in place, especially one that’s cloud-based, archaic issues surrounding time stamps as well as every other element to do with data integrity from the secure storage of data to the required audit trails will be a thing of the past.
To upgrade your existing set-up to a the Hark system get in touch to book a demo. Our cloud-based platform is completely retrofittable and we work with companies to bring their existing hardware into the smart age.
