An automatic colony counter allows any modern microbiology laboratories to perform the colony counting simply and reliably. This leads to standardized, accurate results for both whole plate and sector counts.

However, those Food and Drug Administration (FDA) regulated companies that want to use electronic quality records and electronic signatures must follow the normative 21 CFR Part 11 which implements controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing the electronic data.


The requirement of FDA 21 CFR Part 11


The FDA issues regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

This regulation aims to permit the widest possible use of electronic technology, guaranteeing the responsibility of the FDA to promote and protect public health.

If you are looking for an instrument complying with the 21 CFR PART 11, you should take into account the following items:

For controls for closed systems, systems to which access is controlled by persons responsible for the content of electronic records on that system. These controls include measures designed to ensure the integrity of the system such measures include:

  1. Validation.
  2. The ability to generate accurate and complete copies of records.
  3. Archival protection of records.
  4. Use of computer-generated, time-stamped audit trails.
  5. Use of appropriate controls over systems documentation.
  6. A determination that persons who develop, maintain, or use electronic records and signature systems have the education, training, and experience to perform their assigned tasks.

The regulation also addresses the security of closed systems and requires that:

  1. System access be limited to authorized individuals.
  2. Operational system checks be used to enforce permitted sequencing of steps and events as appropriate.
  3. Authority checks be used to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform operations.
  4. Device (e.g., terminal) checks be used to determine the validity of the source of data input or operation instructions.
  5. Written policies are established and adhered to holding individuals accountable and responsible for actions initiated under their electronic signatures, to deter record and signature falsification.


The Sphereflash, a safe automatic colony counter for all laboratories


IUL’s Sphere Flash automatic colony counter meets all the requirements of 21 CFR Part 11. IUL  manufactures under ISO 9001 which certifies that the system has been manufactured under a standard of quality and ensures accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.

Records data can be exported to Excel, CSV, and text files. The generated PDF reports and tables can be automatically linked to a third-party application, to be digitally signed to ensure its authenticity, integrity, and authorship.

When exporting or printing reports, the exact data contents of the records in the database are automatically transferred to the file or printout; there is no possibility to modify the data. Furthermore, the results data of each operation can be automatically exported in real-time to an XML file when Remote Out mode is active.

The PRO version of SphereFlash®’s software is provided with a login feature that limits access only to authorized individuals by means of a username and a password. Each user is assigned a role that defines the subset of features for which they have permission. All the changes to the users and their roles, as well as the login events, successful or not, are recorded in the Audit Trail, which includes the date, local and UTC time, user, and change that has been performed.

All the records of the active database are directly available for review, export, and print until the authorized user performs a purge of the outdated records into an archive file. Even in the archive file, the outdated records are still safeguarded under encryption, and they can be retrieved for their consultation if needed.


Get advanced technology for laboratories

The SphereFlash® is able to perform the colony counting in a simple and reliable way thanks to its world-class software and its patented built-in lightning system.