Quality Systems – Computer System Validation

Computer System Validation is our bread and butter. Having managed the practical deployment of systems for multiple sites on different continents, detailed knowledge of the topic is available. We participated in a three day CSV Masterclass where we connected with other experts in the field as well as received detailed training of recent updates to the regulations.

Implementation

We can provide support for the project based deployment of new quality management systems (QMS).

We bring experience with regards to the implementation of a TrackWise® system used for Deviation, CAPA and Change Control management.

Based on a charter and a detailed project plan project members will be managed to execute the different aspects of the practical implementation of the QMS. There will be periodic, at least weekly, team meetings and individual members will be coached in 1-1 meetings should that be required.

The project plan will be developed in close cooperation with the software vendor and company representatives when required. For end users sufficient training will be given, and should the scale require it, a train-the-trainer methodology will be used.

By using GAMP methodology part 11 / Annex 11 compliance is warranted. During performance qualification (requirements) testing, special attention will be given to ensure SOPs are applicable and useful for the end user community. We can write and execute performance qualification scripts.

Improvement, simplification

We can review the current state of the QMS, and by using the DMAIC lean/ 6-sigma methodology cooperate with company representatives to improve and simplify those aspects of the QMS where the improvement will have the most impact. We have supported a South-Korean team in preparing for the implementation of a LIMS system, after which they immediately could identify and resolve areas where inadvertent inefficiencies had entered their system.

Maintenance

Bringing close to two decades of experience in multiple companies we hit the ground running and require minimum time to adapt to a new environment. If there is an acute need due to resource limitations or other reasons, we can join the team and minimize detrimental impact of the limitation.