Beschrijving
ComSoft 21 CFR Part 11 is validatable software that meets FDA requirements within a closed system, with conformity to the CFR guidelines confirmed by an independent institute. It is intended for regulated environments where secure handling of data-logger measurements and full traceability of user actions are essential.
This article is part of Calibration, service & certificates.
Digital signature and audit trail functions support maximum security by enabling traceability of user activities. Raw data are stored in a tamper-proof file format, while checksums help detect transmission errors. An inactivity lockout reduces the risk of unauthorised access. The intuitive, clearly structured interface guides the user through individual work steps and simplifies data export, report creation and analysis. All captured measurement parameters can be presented and evaluated graphically as well as in tables. Measurement menus are individually adaptable, and data loggers can be grouped in clear tree structures by place of use and purpose for a transparent view of the full transport path. Additional functions include online measurement, formula creation and scientific-statistical evaluation (min/max/mean, limit exceedance). One piece from manufacturer Testo supports compliant monitoring workflows.
Key features
- Pack size: 1 pc
- Compliance focus: Validatable software for 21 CFR Part 11 closed systems
- Security: Digital signature, audit trail and inactivity lockout
- Data integrity: Tamper-proof raw-data format with checksum verification
- Analysis: Graphical/tabular evaluation plus min/max/mean statistics
- EAN: 4029547015182
- Technical Information Sheet:
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Questions about ComSoft 21 CFR Part 11 - software
What is this article?
ComSoft 21 CFR Part 11 - software is the article on this page. Luminix Health distributes Testo for laboratory use. It sits in Calibration, service & certificates, in Instrumenten.
A calibration compares an instrument with a standard and writes down the difference. The certificate is that comparison: the standard used, the points, the uncertainty, the date. Without it, a balance or a pipette is only claiming to be right. Accreditation is what tells you the laboratory that signed the certificate is itself checked. European comparison of standards is EURAMET. Belgian accreditation is BELAC. The units themselves are the BIPM.
Which category should I open next?
The category is Calibration, service & certificates. The catalogue is Instrumenten.
Shelves beside this one are Instrumenten.
What should I check before I order?
When this page shows a safety data sheet, use that manufacturer file. Hazard text does not belong in the sales description. For a pack size, a grade or a certificate that is not on the page, send a quote request or contact the team.
How does ordering and shipping work?
Luminix Health distributes this article from the heart of Europe. Articles in stock ship within 2–5 business days. Standard delivery is free from €250 excl. VAT. Cold-chain goods and dangerous goods under ADR are never included in that free delivery. The terms are in the Shipping Policy. The full brand index is on shop by brand. Who we are is on about us.
Which other categories should I open?
The seven catalogues are Labware, Lab chemicals, Lab instruments, Lab consumables, Chromatography equipment, Lab safety equipment and Life Science & Microbiology.