Validation

Computer Systems Validation

We can provide global business solutions to you with expertise in GxP computerized control systems and the structured Software Development Life Cycle (SDLC) methodologies.

 

Lab Systems/Instruments validation

Whether the need is for validation of laboratory systems (e.g. Laboratory Information Management Systems (LIMS), Chromatography Data Acquisition Systems) or qualification of stand-alone instruments, we can provide skilled consultants with lab bench experience to handle the work. 

 

Clinical Systems

We are experts in clinical system compliance and validation. We provide validation of clinical data systems, e.g. SAS-based applications.

IT/Infrastructure qualification

We help companies implement a compliant process to ensure that their infrastructure is providing the services and documentation that their clients expect. Our services include network qualification, hardware qualification, implementation/validation planning, and standardized IT compliance practices.

 

Process Validation

Sino-American Pharmaceutical Services can help you optimize the manufacturing process, validate the process against the required and designed specifications, demonstrate the control of the manufacturing process, whether it is an API, finished product or packaging manufacturing.

 

Cleaning Validation

We provide cleaning validation services for bulk chemical, solid dosage and medical device manufacturing areas/equipment.

 

Manufacturing Equipment and Facility Validation

We can provide validation for various types of manufacturing and Computer Integrated Manufacturing (CIM) systems. ERP, MES, DCS , PLC , BAS and HVAC, SCADA. Or water systems, autoclaves, blender, fillers, mixer, washer/dryer, etc.

 

Thermal Validation

We can provide world class thermal validation services for a number of systems, such as freezers and stability chambers.

 

21 CFR Part 11

We have extensive experience helping our clients to understand and comply with the FDA's Electronic Records & Electronic Signatures regulation, 21 CFR Part 11. We can provide expertise to perform system inventory, evaluation and re-mediation to bring systems into compliance with Part 11.