Case Study: Medical devices manufacturer

Leading companies in the production of highly critical medical devices have achieved compliance with data integrity requirements through the adoption of Opera Industry integrated with instruments, laboratory machines and business management systems.

The FDA expects data used in GMP environments to be in a state of integrity. The concept of data integrity is summarised using the acronym ALCOA, which states that data must be: Attributable, Legible, Contemporaneous (i.e. recorded at the same time as it is produced), Original or a faithful copy and Accurate (ALCOA).

The MHRA5 includes other terms to help interpret the acronym. ALCOA is Attributable, Legible, Contemporaneous, Original and Accurate, while the “+” refers to being Complete, Consistent, Durable and Available.

Data form the basis of the system that leads to knowledge about a product or process. Consequently, many standards have been developed to ensure the collection of valid data. The sentence ‘Garbage in, Garbage out’ was well understood before the advent of computers. The issue of data integrity has focused on the activities of company laboratories, since this is where most data is collected, but it must be remembered that production processes generate data even without the use of laboratory facilities.
The statement: ‘Data must be recorded directly, promptly and legibly’ tells us that the first data record is the ‘original data’. There must be no intermediate records or copies. The term ‘promptly’ means that the recording must be made as soon as possible after the generation of the data. Furthermore, if an electronic record is used, it is necessary to have a function of ‘change tracking’ that records modifications from the original record.

Customers who have adopted Opera Industry for laboratory and production data integrity management have been able to collect and manage data thanks to the multiple validated communication interfaces that are available.

Our data integrity management process consists of the following steps:

• Login of enabled users with P11 compliant accounts
• Collection of Raw Data from the tool that generates it
• Protection of the raw data during the generation process from any changes
• Addition of metadata to characterise the records
• Assignment of a unique identification code
• Transfer of Raw Data and metadata to a centralised database
• Historical record of all accesses and actions performed by users on the electronic record
• Data Integrity report with highlights of the electronic record

The whole software and integration is validated, including clients, servers and interfaces. All records are subject to automatic Audit Log.

The collection of data from the instruments that generate them represents the greatest challenge due to the variety of technologies with which laboratory instruments, test benches, production machines and GMP document management software are made.

Through various interfaces, clients such as:

• Labview
• Labwindows
• C#
• MQTT
• ModBus
• RS232 and RS485
• TCP/IP clients
• File system based
• Without interfaces