v:kit for HPLC and GC IQ/OQ/PQ

October 2006

 

Dear Reader,

Welcome to the v:kit newsletter. In this publication we aim to keep users and distributors updated on the latest developments in the equipment qualification arena.

In this issue

·  Free v:kit training

·  Hear about the real-world use of v:kit

·  Is v:kit software validated?



Hear about the real-world use of v:kit

There is an excellent opportunity available to hear about the real-world use of v:kit in a regulated environment.

At the upcoming conference on Equipment Qualification & System Validation in Laboratory and Manufacturing Environments to be held in Amsterdam, The Netherlands on December 5-7, 2006 Steve Luke from NLG and Karl Fitt, Analytical Manager, Chemical and Pharmaceutical Development, Evotec (UK) Ltd will be presenting the following session:

INTERACTIVE SESSION 11
Wednesday, December 6, 2006 3:30 PM - 5:00 PM
HPLC Qualification Case Study: An Example From the Real World

I. The Conscious Decision of What Approach to Take for HPLC Operational Qualification
- The HPLC environment at Evotec
- Determining the requirements for HPLC operational qualification - technical and financial
- Selecting the qualification provider

II. The Delivery of the Agreed Operational Qualification
- Details of the actual qualification performed
- How the qualification is integrated into company systems
- Was the approach successful?

III. Interactive Exercise:
Participants will apply the methodologies detailed in the presentation to their laboratories and can compare the result to their existing qualification approach.

Join us in Amsterdam to see how v:kit could work for you and your customers.

Download the conference brochure



Is v:kit software validated?

We are frequently asked if v:kit software is validated.

The answer is yes. Declarations of software validation are available for HPLC and GC v:kit software and can be downloaded from the following web page:

FAQ - Software

These declarations certify that the software was developed, tested and validated according to internal regulations. Functional and performance specifications have all been met. All documentation is available for audit.

In addition an installation qualification (IQ) package is available for v:kit software. This package contains an SOP plus certificate generator and allows the user installing v:kit to complete an IQ designed to meet regulatory requirements.

IQ package ordering details

Part Number: VKIT-SIQ
Description: v:kit software installation qualification package
Price: £100.00

Free v:kit training

Each HPLC and GC Initia v:kit now includes a voucher for FREE training

The voucher entitles you one of the following:

  • 1 cost-free place on a v:kit training held at the NLG Analytical facility in the UK
  • Credit to the value of £400.00 against a v:kit training delivered on your site

Additional places on the v:kit training held at the NLG Analytical facility in the UK can be puchased at a cost of £400.00 per person.

v:kit trainings are held at regular intervals over the year. Training details are as follows:

Duration

  • 1-day

Agenda

  1. Introduction to v:kit - details of the v:kit concept
  2. v:kit test details- in depth discussion of the tests included in v:kit
  3. v:tools - specification of the tools required for v:kit
  4. OQ delivery - qualification of a complete instrument using v:kit
  5. Review - review of the day and opportunity for open discussion

Qualifying products

Part Number: VKIT2-I64
Description: InitiaLC HPLC starter kit
Price*: £1200.00

Part Number: VKIT-IGC
Description: InitiaLC GC starter kit
Price*: £1200.00

* End user price. Normal distributor discounts apply

Click here to request further details

 

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