compliance
I vores artikelarkiv kan du udforske nøgleaspekter inden for kvalitetssikring og overholdelse af regulativer inden for laboratorieudstyr og praksis. Opdag hvordan Cubis II MCA-software og Cubis® II balanceserie kan hjælpe dig med at opnå overholdelse og forbedre nøjagtighed og effektivitet i dit arbejde.
Find mere om:
- 21 CFR Part 11 overholdelse
- Tilpasningsdygtig konfigurering med Cubis® II
- Kvalitetssikring og standarder i medicinsk enhedsudvikling
- Elektronisk signatur og audit trail
- Dokumentation og validering
- Compliance-relaterede ressourcer og vejledninger
Cubis® II MCA 21 CFR Part 11 Compliance Checklist
Is the system a Closed System, where system access is controlled by the persons who are responsible for the content of the electronic records that are on the system?
Is the system an Open System, where system access is not controlled by the persons who are responsible for the content of the electronic records that are on the system? (e.g.
a service provider controls and maintains access of the contents of the system, etc.).
Protecting Data Integrity — Evaluating Instruments in the Lab
Compliance with data integrity regulations begins with all data-generating instruments and extends throughout lab systems—evaluate your instruments and procedures with this checklist.
Cubis® II Pharma Compliant by Design
The Cubis® II balance series was designed for customizable modularity, which means the user can choose from many hardware and software options for thousands of different configurations. Choose from among 45 weighing modules, seven draft shields, two display and control units, and five software packages, including more than 60 software Apps.
Meet the requirements of the pharmaceutical industry with a combination of the MCA high-end 7” display and specific QApp pharma package, providing all features needed for a full pharma-compliant lab balance system.
On the Chapter 2.1.7 “Balances for analytical purposes” of the European Pharmacopoeia (Ph.Eur.)
The new chapter was published in July, 2021 and becomes effective on the 1st of January, 2022. The new chapter is mandatory for any analytical weighing procedure described in a Ph.Eur. monograph.
Are You Compliant When it Comes to Pipetting?
When developing or testing your medical device, there is always the question: are you following methods for current Good Laboratory
Practice (cGLP) or current Good Manufacturing Practice (cGMP)? In this practical guide, we’ve compiled a list that you
can follow to give you peace-of-mind on the topic of compliance.
Vi er en dansk familieejet virksomhed med 43 medarbejdere, der brænder for at give vores kunder en professionel service, der matcher vores kernekompetencer, som er salg, service og kalibrering af laboratorie- og pipetteringsudstyr. Trivsel og performance er parametre, som har stor betydning for os. Vores medarbejdere tager ansvar for deres opgaver, og er altid klar til hjælpe og vejlede vores kunder med rådgivning og service på et professionelt og højt niveau.
Sabine Kähler
Forretningsudvikler
sk@dandiag.dk
+45 3116 9067