Sisthema performs Qualifications (DQ, IQ, OQ, PQ) of equipment, instruments, systems and processes for Pharmaceuticals, Cosmetic, Food and Health companies.
Following the GMP Guidelines and in compliance with the ISO 14644-1:2015 regulation, Sisthema performs environmental validations and instruments’ calibrations, checking the critical parameters and finding possible anomalies and problems in the plants.
During the years, Sisthema has gained a significant experience in the organization and execution of Audits in different fields: Pharmaceutical (API, finished products, excipients, packaging), Medical Devices, Cosmetics and Food.
Using a network of highly qualified auditors, some of which on site, Sisthema is able to perform audits all over the world according to the main regulations and the specific needs of the customer.
Sisthema also offers On-site Training in order to satisfy the customers’ needs and provide practical tools and regulatory updates.
Sisthema can count on a team of trainers able to create customized plans for the company growth and development. The main contents of Sisthema’s On-site Training are:
- Validation, Qualification and Audit
- Quality and Production
Sisthema is able to offer Consultancy in different fields of the Pharmaceutical, Cosmetic and Food sectors.
Thanks to highly qualified consultants, Sisthema can support the companies with targeted projects such as:
- GMP, Good Manufacturing Practices
- Cleaning & Process Validation
- Support in preparation of AIFA and FDA inspections
- Batch Record Review
- PQR, Quality Review, Root Cause Investigation and CAPA
- GAP Analysis
- Elemental Impurities ICH Q3
- Support in writing the SMF
- Quality Agreement
- Risk Management & Risk Assessment GMP
- Supplier Audit
- Data Integrity
- ISO 9001 – ISO 13485 – ISO 22716
- Regulatory Activity