V:Kit Software Platform with UV-Vis Protocols
A range of test templates with SOPs for UV-Vis Spectrophotometers for delivery and execution by V:Kit software.
The tests supplied in the UV-Vis protocols include the setpoints and limits for meeting current USP 857 and Ph. Eur. requirements.
V:Kit's flexible, protocol designer tools allow users to build customised protocols, ideal for companies that need to comply with more than one pharmacopeia by combining tests from each.
The software will integrate with Certified Reference Materials supplied in sealed, quartz cuvettes from Starna® and Hellma®, as well as liquid standards from Merck® and Agilent®
Standard Operating Procedures
Each test design contains a SOP which is directly accessed from the software. They are centrally distributed and are only accessible by authorised users. Full version control is enabled, and obsolete versions automatically archived, preventing use of out of date procedures.
Each SOP provides instructions on how to execute the test and documents the formulae and calculations used in the data evaluation. This assists the process of data checking by Quality Assurance or external auditors.
Certificates of Analysis
COAs are directly accessed from the software, which automatically extracts and embeds the analytical data directly into the test protocol. This avoids transcription errors and prevents accidental use of out of date materials.
The COA of a batch of a standard used in a OQ/PQ test can be electronically attached to the qualification report. So no more photocopies or poor quality scans….
V:Kit COAs follow ISO guidelines regarding certified values, intended use, homogeneity, storage, hazard and quality information.
Operational Qualification Test Templates
- Control of Wavelength - Rare Earth Oxide (USP)
- Control of Wavelength - Holmium Oxide (EP)
- Control of Absorbance Accuracy - 60mg and 600mg K2Cr2O7
- Control of Absorbance Precision - 60mg K2Cr2O7
- Control of Absorbance Accuracy - Neutral Density
- Control of Absorbance Precision - Neutral Density
- Limit of Stray Light - Acetone
- Limit of Stray Light - Potassium Chloride
- Limit of Stray Light - Sodium Iodide
- Limit of Stray Light - Sodium Nitrite
- Resolution - Toluene in Hexane