ALCOA is a framework for ensuring data security and data integrity, with the goal of consistently having “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:

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Balancing Lab Efficiency with IT and Compliance Requirements

In the pharmaceutical industry, maintaining the integrity and authenticity of data is a critical imperative. To meet rigorous quality and compliance standards, pharmaceutical companies have embraced ALCOA, representing a set of principles that ensure data reliability and traceability across drug development and manufacturing processes. ALCOA has become a foundational framework in pharmaceutical data management.

This method’s importance cannot be overstated, as it plays a pivotal role in upholding product quality, patient safety, and regulatory adherence. As pharmaceutical practices evolve to meet emerging challenges, the ALCOA method remains a steadfast ally, helping companies navigate the complex regulatory landscape while prioritizing patient well-being.


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 using 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, 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.

Enduring and Available

  • 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 Informatics Platform is stored within the Microsoft Azure Cloud. Additionally, bundles of each document and all associated files are generated and can be stored locally on the user’s server or computer.


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What Our Users Say

Don’t take our word for it. We exceed our client’s demands everyday to make their research and discovery process simpler and more efficient.

We have been audited by FDA twice and they had no concerns about the system nor any findings.

Deb Carr,
Director, IPD

This is by far the best value in science software (or anything else in science, really) that we’ve ever experienced. Other solutions in this price range had a fraction of the features, and those with the features cost 3x – 10x more. We’re very happy customers.

Josh Guyer,
Senior Pharmaceutical Scientist

In a head to head competition, SciCord was 3x more efficient at documenting a typical work process than [competition]. A complete ‘Assay’ work process required 60 minutes in [competition], while only 20 minutes in SciCord!

Indu Chowdhary,


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