In the life cycle of each project, commissioning and qualification processes are the last steps to ensuring reliable and compliant installations and equipment for safe production and optimized quality.
AKKA is today a recognized partner for pharmaceutical companies in qualification and validation in these areas:
- Commissioning (FAT/SAT execution, protocols and reports writing and reviewing)
- Installation qualifications (protocols, test and reports)
- Operational qualifications (protocols, test and reports)
- C&M coordination
- Performance qualifications (protocols, test and reports)
- Validation deviations and non-conformities
- Planning and capacity management
We enable and deliver these activities for primary equipment, secondary equipment, clean/black utilities, and laboratory equipment.
We can provide this support with experts on demand or by working with our clients directly on site. When our client prefers a stronger partnership, he can also outsource the whole activity to AKKA.
We will create a dedicated team, sized according to work requirements, and perform the activities with clear commitments on quality, pricing and deadlines.