A working staff composed by more than 15 specialists headed by a validation manager, more than 1000 IQ/OQ protocols in the last four years; about 600 FS/HDS/SDS protocols in the last four years; approximately 200 change control per year. These are only some of the figures of our Validation Department.
Marchesini Group supplies a Validation Protocol written in according to cGMP and GAMP5 standards, created and used for the pharmaceutical sector.
Our team of experts clearly describes all stages of machine procedures, compile Functional and Design Specification, prepare and execute Installation Qualification (IQ), Operational Qualification (OQ) in compliance with the relevant standards and regulations.
Validation Documentation is created by working closely with the customer, who can request specific tests for each machine, to define system specifications and all testing sheets needed to carry out the test which the system must undergo.
This sector is covered by a dedicated team of specialist working at Pianoro headquarter, where the work of our validation personnel employed by other Group companies, is also coordinated to achieve an uniform validation.
Support does not end when the machine is delivered to the customer, but can continues with the passage of time even as regards any subsequent modifications to the machine (Qualification of modifications and extension of equipment).
Marchesini Group Validations:
- QP (Quality & Project Plan)
- FS (Functional Specifications)
- HDS (Hardware Design Specifications)
- SDS (Software Design Specifications)
- Program List
- Flow chart
- IQ/OQ Test protocol
- Change Control Specification
- Certificates of Product Contact Parts
- Certificates of Critic Instruments Calibration
- 21 CFR Part 11 (FS and Test Protocol)
- Traceability Matrix