Data Integrity and a true PET LIMS
31 January 2017
Is your LIMS software ready for the scrutiny of a GMP inspection? Could you face the inspectors with the confidence to say, “Our LIMS software helps us comply with the necessary regulatory requirements on Data Integrity”?
Data Integrity has been a “Hot Topic” in the pharmaceutical industry for a few years now. The frequency with which the regulatory inspectorate ''fix'' their focus on Data Integrity during GMP-compliance audits is ever increasing.
It is worth reflecting on the minimum regulatory expectations for Data Integrity from the point of view of the US FDA, MHRA and the European EMA. In this article we will present how LabLogic are incorporating the relevant, specific features into PETra which enable our customers to be compliant in the key area of Data Integrity.
The FDA issued draft guidance as recently as April 2016 entitled, “Data Integrity and Compliance with CGMP – Guidance for Industry”. In this document the definition of data integrity is related to the completeness, consistency and accuracy of the data. The document introduces the acronym ALCOA, stating that, “Complete, consistent, and accurate data should be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate.”
Attributable - relates to the source of the data and for this we need to consider not only the equipment or system generating the data, but also the persons responsible and on duty at the time of batch manufacture and testing.
For PETra systems, all aspects of data generation and retrieval is tested in the qualification stage of the software implementation on site. The persons responsible for requesting or checking the data must be logged onto PETra using a unique User ID. The access to specific functionality is restricted and defined in the the User’s profile (e.g. as Technician, Manager, Administrator, Super User, etc.) and all interactions with the system are recorded in a secure (encrypted and uneditable?) audit trail. The log-in features present in PETra in this important area are customizable, but always enable the customer to configure the system to be in compliance with the requirements of FDA 21 CFR 11 and Annex 15 of Eudralex Volume 4.
Legible – The legibility of the data is guaranteed within PETra, since the information is in an electronic format, and may be viewed on screen or printed. This includes the possibility of the User Interface and printed materials appearing in most common foreign languages.
Contemporaneously recorded – Each item of data generated and stored in PETra has a time/data stamp. This time stamp, along with other “metadata” such as units, equipment source ID, instrument calibration status, etc. are logged in the PETra database in a packaged, retrievable and interrogatable form.
Original or a true copy – Instrument data in PETra is either retrieved directly via a physical instrument interface (cable) or a true copy is generated from a Transfer Protocol provided by the instrument control system and tested in the qualification phase by LabLogic.
Accurate – The Maintenance Module in PETra enables the user to keep records of the calibrated status of the instruments in the manufacturing and Quality Control systems. The user is prompted in advance when essential maintenance or calibration is due. In this way, the system gives both the users of the system and, more importantly, the Qualified Person responsible for releasing the batch, the required confidence in the accuracy of the key batch-related data held in the PETra database.
We hope that this short article demonstrates why we are so confident in the PETra system when it comes to Data Integrity.
For more detailed information on PETra contact firstname.lastname@example.org to arrange a demonstration and/or to discuss a quotation. Remember that we have many satisfied clients who will be only too pleased to allow you to see the software in action on their site.