Quality Systems Design & Implementation
Our consultants are experienced in the design and implementation of quality systems for deviations, complaints, CAPA and change control. Our competence is based on actual cases with both multi-national and SME clients.
We have implemented both manual and electronic document management systems. Our support can be a part of your internal project team or a complete solution.
Interim Quality Management & QP Services
A number of our consultants have 10-15 years experience in Quality Management in multi-national Pharmaceutical & Healthcare companies. This experience is available to our clients for short term assignments to manage specific change objectives or to substitute for permanent staff on leave absence. In addition, we have personnel experienced in QP roles who are available for contract assignment. Depending on your process and the extent of the contract, it is quite likely that we can offer you support. Please note that QP support requires a period of induction and must meet regulatory expectations. As such, please contact us as soon as possible if you anticipate a need in this area.
Quality Systems On-going Support
We can help you to prepare or upgrade your policies, procedures and master plans. If you have an unexpected work peak loading or need to prepare for a major regulatory audit then we can help. During 2007/8 we have supported two major clients with the transition to FDA compliance including gap assessments and PAI preparation. We perform risk assessments in quality for example the introduction of additional products to a plant or achieving efficient compliance by focusing effort based on an impartial and well justified assessment. Recently, the IMB expressed concern that companies use risk assessments to justify decisions rather that using an impartial assessment to determine the outcome. One way to demonstrate impartiality is to use a well established independent company specialising in compliance.
QC LIMS and E-tools
The implementation of a LIMS is complex and issues like vendor selection are challenging as vendors will naturally tell clients what they wish to hear. We have experience of LIMS implementation both at local and global levels and ideally placed to help you set-up your LIMS project and ensure you are in-control of the project when facing vendors. We have implemented trackwise and document managements systems and can support your client team in planning and/or executing these projects.
Validation & Verification
Our consultants are experienced in validation especially the development and approval of master plans and the approval of protocols and reports to ensure compliance standards are met. For major projects you may wish us to undertake an interim or final audit to confirm the project is on-track or complete from a technical and compliance perspective.