ProtectionPlus Module: Regulatory compliance and data integrity


Description

This configurable security and data integrity module offer the tools necessary for users to be compliant with laboratory and data regulations, 21 CFR Part 11.

Compatibility

This app requires the latest version of LabSpec 6. If you do not already own LabSpec6, please contact us to check your system compatibility with LabSpec 6.
Please contact us, for a good implementation.

Conditions of use
- App usable on a single PC
- Can be transferred to another PC via HFR
- Permanent license
- Free updates in LabSpec6

Contact us

If you have any further questions, please contact us using our contact us form available here: Contact us.

Details

HORIBA Scientific’s range of Raman spectrometers can be used with assurance in regulated environments with the LabSpec 6 ProtectionPlus module. This highly configurable security and data integrity module offers all of the tools necessary for users to be compliant with laboratory and data regulations, including 21 CFR Part 11 of the FDA’s Code of Federal Regulations, Title 21, relating to electronic records and electronic signatures.

Within the scope of Raman spectroscopy, an electronic record is data represented in digital format that is created, modified and archived by a computer system. The regulations are used to ensure the validity of the data throughout its lifetime, tracking how the data was acquired and modified, and recording which user was responsible for all such actions.

The optional use of electronic signatures allows users to electronically authenticate data, and provide a legally binding commitment to its validity. Note that compliance with the regulations requires more than just installation and use of the ProtectionPlus module. Specific company policies and laboratory best practice must also be strictly followed, and users must be suitably trained to work in a compliant manner.

Since the regulations are not highly prescriptive, the ProtectionPlus module is designed to be a configurable unit, offering a wide range of tools which can be enabled and configured by a security administrator - this ensures that a company specific interpretation of the regulations can be accommodated with ease.

Key functional blocks of ProtectionPlus:
  • User access management and control
  • Electronic record audit trail
  • Event log application audit trail
  • Electronic signatures
  • System policies and file management control

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