Before the Warning Letter: Why a digital, tamper-proof, and automatic device qualification ensures high data integrity

Chromatographic systems contain numerous components that need to be regularly checked and maintained to ensure the precise operation of the devices. (Source: AnaTox GmbH & Co. KG)

Chromatographic systems contain numerous components that must be regularly checked and maintained to ensure the precise operation of the devices. (Source: AnaTox GmbH & Co. KG)

Chromatographic systems contain numerous components that must be regularly checked and maintained to ensure the precise operation of the devices. (Source: AnaTox GmbH & Co. KG)

Many laboratory areas across various industries use chromatographic systems for precise substance separation. (Source: AnaTox GmbH & Co. KG)

All parameters are continuously monitored, and the recorded results – including all raw data and metadata – are stored in the company's AIQ database, so they cannot be manipulated through external access. (Source: AnaTox GmbH & Co. KG)

Detlef Wilhelm is the managing director of AnaTox GmbH & Co. KG and has developed an ALCOA-compliant qualification software for chromatographic systems with the AIQ software. (Source: AnaTox GmbH & Co. KG)

Without reliable and comprehensive research data, there can be no approval, for example, for new medications. Therefore, laboratories worldwide are required to adhere to the ALCOA guidelines of the American Food and Drug Administration (FDA) for their measurement systems in their documentation, among other things. If gaps are revealed during an audit because, for example, certain metadata are missing or manual adjustments are not traceable, this can lead to stricter regulations and, in repeated cases, even the closure of the laboratory. To ensure high data integrity from the outset, AnaTox offers a specialized software that enables the laboratory to reliably and tamper-proof collect and document all maintenance, repair, and qualification data. The AIQ-Tool software is particularly user-friendly: qualifications can be performed by an experienced technician as well as a trained in-house employee – the results are comparable and compliant with standards.

In many laboratories, in addition to the actual research, collecting and evaluating the generated data is part of everyday life: spreadsheets are created, results are processed in open-source systems, data are stored in third-party cloud services, systems are upgraded, and the next audit is prepared with a mixture of paper and electronic records. Especially in the field of drug development and manufacturing, strict regulations ensure that the entire process from development to quality control of the finished medicinal product, including all collected data and performed tests, is fully traceable. During audits and inspections, laboratory personnel must therefore be prepared to answer all questions regarding compliance, including the qualification of their equipment and systems. The regulatory authority can pose questions from two different perspectives: on the one hand, regarding data integrity, and on the other, concerning compliance with qualification regulations.

This has changed the questions faced by regulated laboratories in demonstrating compliance according to USP standards. The qualification of instruments must therefore be based on scientific principles and include the necessary level of metrological testing, properly dimensioned according to laboratory requirements. The AIQ tool from AnaTox can significantly support this: with this software, authorized device users are enabled to perform qualifications and maintenance independently and manufacturer-agnostically in a very short time, as well as to tamper-proof document various parameters and changes to the hardware. Data integrity always meets high standards and provides additional legal security.

Fully electronic documentation prevents orphan data* and their manipulation

The implementation of qualifications with a fully electronic protocol offers the lowest risk regarding data integrity issues, as manual entries and/or calculations are ideally minimized. Therefore, the AIQ software conducts all processes electronically, automatically storing all data, including parameters, in a dedicated database. This applies to operational qualifications (OQ), maintenance (PM), re-qualifications after repairs (RQ), and performance qualifications (PQ). As a result, all data related to an instrument are stored in a central location and are clearly accessible, including their audit trail protocols.

All reports related to the respective instrument concerning compliance activities are immutable. This ensures that data and reports are neither lost entirely nor partially. Conversely, it reduces the risk of intentional or unintentional changes to recorded parameters and results. At any time, it is possible to trace which operator performed which actions. This also maintains the temporal relationship between measurement and data evaluation, as, for example, post hoc manipulation of timestamps is excluded.

AIQ tool considers customer-specific requirements (URS)

Nevertheless, the AIQ tool remains flexible: customer-specific requirements (URS) for qualifications can be easily incorporated by adjusting measurement parameters of tests. For example, it is not practical for many laboratories to verify the flow precision of an HPLC pump at 5 ml/min. Instead, these should be performed close to the intended method parameters, which were established during the design qualification for the device. Since such adjustments are automatically and seamlessly documented by the AIQ tool, the results retain their authenticity and validity despite modifications to the setup by operators.

In addition to documenting the results and procedures of scientific measurement methods, the AIQ tool also allows for user-friendly maintenance management according to manufacturer specifications, which further enhances data integrity. When devices are registered via the tool, their status and error messages are automatically documented. This enables personnel as well as qualification auditors to track all activities related to the hardware. This also includes “changes” such as module replacements after repairs, without the need to re-qualify the entire system. Since the cumbersome collection and review of various protocols are eliminated, the AIQ tool also facilitates internal quality control work as well as audits by authorities and customers. The documentation of all activities for all instruments is harmonized. This significantly reduces the effort involved in tracing, reviewing, and approving the devices. Consequently, the “instrument downtime” is greatly reduced, and nothing stands in the way of secure and efficient quality control.

* R.D. McDowall, LCGC Europe, October 2022, Volume 35, Issue 9