Areas of Expertise







 

 
 

 

Technologies
Regulatory Compliance
Operations


Using common standards, SciTech Engineering is able to deliver a comprehensive set of regulatory compliance and validation services around the world.

Quality Compliance Services (QCS)
These include: GMP auditing; mock inspections; regulatory filing; validation policies and validation master plans; preparation of design qualifications, installation qualifications, operational qualifications and performance qualifications for a wide range of facilities, processes and equipment; standard operating procedures; validation report preparation; calibration; process and equipment cleaning validation; scientific consultancy; and a comprehensive range of training programmes.

Integrated Commissioning& Qualification (C/Q)
With its high calibre, engineering, management & qualification staff, SciTech Engineering has pioneered the application of integrated commissioning & qualification. Using the principles of Good Engineering Practice (GEP) and an Integrated Quality System approach to the design, engineering and construction management of GMP facilities, SciTech is able to optimise the effort expended on qualification activities and focus on the manufacture of products.