Data Integrity and data quality: ALCOA+, SOP guidance, data management in the lab
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How to Achieve Data Integrity in the Laboratory

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A knowledge collection on the ALCOA+ principle, data management and practical tips to ensure data integrity in the laboratory

Following ALCOA+ to achieve data integrity in the laboratory

The acronym ALCOA+ defines a framework to achieve data integrity, especially important for regulated industries. In order to meet regulatory requirements, your laboratory data – printed or electronic – must be:

  • Attributable – Record who performed an action and when.
  • Legible – Data must be readable throughout the entire lifecycle of the record.
  • Contemporaneous – Documented at the time of the activity.
  • Original – Original record or a certified copy.
  • Accurate – No errors or editing without documented amendments. Reliable data.
  • Complete – All data, including any test, repetition or reanalysis performed. Data (records) must be complete..
  • Consistent – All elements of the analysis such as the sequence of events follow on and are date or time stamped in the expected sequence.
  • Enduring – A sustainable record (systematically documented) in laboratory notebooks or validated systems.
  • Available – Can be accessed for review and audit or inspection over the lifetime of the record.

The ALCOA+ poster gives a concise overview of the 9 points to data integrity for your laboratory.

Download ALCOA poster

Lack of data integrity as main reason for FDA warning letters

In 2016, 80% of the FDA warning letters were issued due to the lack of data integrity. The main reason was incomplete data, an aspect that can be prevented by using the right solutions. The highest risks, when not working in a compliant manner, lie in import bans, product re-calls or even the closing of production plants.

For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or documented evidence of all relevant analyses that can be checked by a second person and are also readily available for audits. Storing the result is not enough, each result set has to be complete and contain all relevant metadata.

Data integrity in the context of 21 CFR part 11 and EU Annex 11 Compliance

The US FDA and European Commission have defined the criteria for ensuring trustworthy and reliable electronic records and electronic signatures in computerized systems of regulated pharmaceutical industries. Several pharmaceutical companies have recently asked for 21 CFR Part 11 certification for instruments not connected to a PC, just using the instruments' firmware. But according to experts, standalone instruments cannot be 21 CFR Part 11 compliant and concepts, which are presented as a feasible workaround, may result in data loss or worse.

Data management with common software

Common software can play a key role in a lean automated data integrity solution. Common software, such as METTLER TOLEDO’s LabX or STARe, has to be validated only once and every new analytical instrument attached will just require an amendment via change control as the software, data management, audit trail, user management, result flow etc. already are validated.

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