We offer complete validation solution for automated manufacturing practices as per regulatory
compliance in pharmaceuticals, life sciences, healthcare Industries.
We provide effective, systematic, quality based validation solution to fulfill regulatory requirements in appropriate time frame.
We have expertise in making & execution of validation protocol for computer based validation system.
Computerized Systems using PLC have been utilized for controlling drug manufacturing equipment. Such as Computerized Systems is referred to as a PLC based as Computerized Systems. Upon the use of PLC based Computerized Systems (PBCS), the regulatory authorities require drug manufacturers to prove their Computerized Systems has adequate functions and performance
Equipment Qualification is a term used to describe a set of independent procedures that are used to check if a product meets the specifications and requirements of intended purposes it ensures your product will consistently perform with in a given range.
BMS System Validation
BMS covers computerize system, network architecture and instrumentations/devices as controller (inputs/output) whereas it is monitoring for GMP elements and Non-GMP Elements.
Lab Equipment Validation
The laboratory needs to know whether the equipment used to provides valid and desired data. With the help of performance specifications of piece of equipment, the laboratory explains which data or which specifications the laboratory wants to obtain by using the piece of equipment.
Clean room validation is HVAC Validation is performed for a variety of reasons. To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment and environment meets URS; to ensure that the facility, equipment and environment meet defined regulatory requirements; ; to ensure that the facility, equipment and its environment function together as a system to meet defined standards.
Spread Sheet validation
When using spread sheets or programmable calculators for reduction of data generated by sample analyses, there should be assurance that the results are valid and usable for regulatory use.