Regulations Compliance

Improve your lab compliancy by using LabCollector to handle 21 CFR 11, Annex 11, GxP and ISO rules

Data Inventory Compliance

Archive of records

A record can be easily archived with a single click. The record will not be displayed in the search results unless a specific filter is applied. Modification will not be allowed in archived records and can only be duplicated, printed or stored. Records with storage or linked to another element cannot be archived.

Reasons to edit a records

In order to follow and ensure the interest of the modifications made, predefined reasons can be created. These reasons will then be proposed when saving a modification and will appear in the version list and the audit trail. Other reasons can be added manually.

Lock record and read-only function

A record can be locked to avoid further modifications and to ensure its integrity. This lock is visible in the version list.
A read-only record will be displayed in the search results, but no changes will be allowed. This action is irreversible (only the super-administrator can undo it) so the record will always remain in the current version.

Custom fields can be created as read-only fields to avoid any modification of this predefined field.

Only available in the Compliancy Pack – Contact us for more information

Records & custom fields’ versioning

Versioning keeps track of all changes saved to the record. Changes are also tracked in the audit trail. However, versioning provides a simple method to quickly access information on a record-by-record basis.

Only available in the Compliancy Pack – Contact us for more information

Encrypted custom fields

Data in a custom field type text can be encrypted in the database and is only visible in the UI. Search filters and searchable options are not possible in this case.

Only available in the Compliancy Pack – Contact us for more information

Other Compliance Features

Audit Trail Log

LabCollector allows you to have audit trail log for all the changes made in the LabCollector. In order to find the information without difficulties, it is possible to search by keyword, date, day or by module.

E-signature of records and reasons to sign

Electronic signature on blocked records allows to guarantee the integrity of the data. Signatures are shown in the version list and the audit trail. In order to ensure effective data tracking, the user must provide a reason for signing this record. Pre-defined reasons can be created. These reasons will be visible in the versioning and audit trail.

Only available in the Compliancy Pack – Contact us for more information

Login options

Login options will show you different options to login and also allow you to configure the LADP/AD and Single Sign On (SSO) authentication function. Other options are available like Two Factor Authentication or Captcha test. More stringent password rules are possible if you decide to enable this feature.

Compliance with Electronic Lab Notebook

The ELN add-on offers by default many options for tracking changes to ensure data integrity and no loss of information:

ELN e-signature

LabCollector’s ELN includes an easy-to-use electronic signature validation system that allows data integrity check (based on CFR 21 Part 11 and patents requirements). Notebook pages can be signed by both the authors and admin users. E-signatures give proof of content validity at signature date.

This option must be purchased

Compliance with Lab Service Manager

Lab Service Manager has its own rules of regulation in addition to the basic rules.

NOTE

LabCollector can help with compliance if used correctly.

Compliance requires a thorough reading of the appropriate regulations. It is up to each laboratory to determine which regulations require specific training or practices. The responsibility for some regulations related to the use of software and electronic records rests primarily or entirely with a laboratory and not with the software that is used in the laboratory.

Many aspects of compliance require LabCollector end-users to take on certain responsibilities, such as training staff in certain concepts, which is not possible for the software. LabCollector users should always review the appropriate regulations and guidance documents that apply to a particular situation to ensure compliance.