ALCOA is a framework for ensuring data security and data integrity, with the goal to consistently have “quality data”. SciCord follows the ALCOA + model when developing their ELN/LIMS solution to ensure that the data captured is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available:

Any data should be easily identified to the person who did the data collection, place of origin, and the time of data collection. If alterations of the data occur, details should be provided based on the individual making the correction.

  • SciCord ELN/LIMS is designed fully compliant with CFR 21 Part11 including electronic signatures and audit trails.
  • The Audit Trail includes the author/modifier of the data, the timestamp of the original and modified data, and the location of the data within the system.
  • SciCord ELN/LIMS notebook has passed FDA audits and is suitable for GxP use

Data can be easily read. This extends beyond handwritten articles, but includes readability in both the short and long term, using materials that should be durable.

  • SciCord ELN/LIMS utilizes an Excel-like platform for spreadsheet visualization which allows for exporting data in multiple file formats, including Excel, CSV, and PDF files.
  • The readability of scientist’s entries is enhanced through the use of formatted templates that walk the reviewer through the experimental process for any and all testing performed.

Data recorded should be contemporary in nature. The time of data collection should correspond accurately with the time of data recording. Any manipulation of the data should also include a date and timestamp.

  • SciCord ELN/LIMS monitors the data recording and includes timestamps that are based on a standard, internal time that is separate from the user’s computer date/time
  • Each entry, whether it is an initial or modified recording, will receive a timestamp.

The original data records should be preserved.

  • If the data is initially brought into the system by importing data files, the files will always be retained to ensure the original data can be retrieved
  • If the data is entered directly by a user or an instrument, an audit trail will track when the data was entered and its value. If this value is modified, it will always be possible to trace it back to the original value.
  • Depending on the needs of the experiment, original values can be locked to prevent changes.

For any data to be viable, the data should be error-free. If any amendments occur, accompanying documents to support the changes must exist.

  • SciCord ELN/LIMS includes configurations for both compliant and non-compliant laboratories
  • In the case of a compliant laboratory, a configuration can include adding an “amendment reason”, which would force the user to include a reason for the modification.

No deletion of data has taken place from the date of documenting, and includes any changes that have occurred during the life of the data.

  • Initial and modified values are stored within the Audit Trail
  • Attachments are stored regardless of whether they are removed or overwritten and can be accessed.

Data should be chronologically arranged, with time stamps for any amendments to the original data. Various audits should be applied over the life of the data.

  • Data in the Audit Trail can be viewed in multiple ways: cell, worksheet, or workbook basis
  • The SciCord ELN/LIMS allows data to be recorded with an easily repeatable, consistent method.

  • Enduring – The material used to record the data should last for a long duration without losing the ability to read.
  • Available – Data should be easily accessible over the life of the data.
  • Data within the SciCord ELN/LIMS is stored within the Microsoft Azure Cloud, however, Bundles are generated and can be stored locally on the user’s server or computer.

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