- NEWTRONIC helps in identifying the test requirements and testing procedures. Our technically qualified sales team understands the customer's requirement and accordingly offers the best suitable equipment on the basis of the test requirements, load in the chamber, future expansions and availability of space.
- PRE REQUISITION : A pre requisition is being provided to the customer to help identify the requirement of uequipment. This helps the user to prepare the installation site before the equipment is received.
DQ, IQ, OQ, PQ : To help the customers to meet current regulatory requirements for equipment, NEWTRONIC can provide DQ, IQ, OQ, PQ protocols. This protocol ensure that system is properly installed, operate according to NEWTRONIC recommendation and adequately documented and controller according to regulatory requirements.
- CALIBRATION, VALIDATION : All the chambers are calibrated and validated at factory prior to dispatch. The chambers are re validated at the time of installationas a part of Performance Qualification. In addition NEWTRONIC can arrange scheduled calibration and validation services for NEWTRONIC's equipments.
- SERVICING : NEWTRONIC has network of sales and service centers at all over India, which are again supported by Head Office.
FDA has defined validation as:
- Established documented evidence which provides a high degree of assurance that a specific process will consistentlyproduce a product meeting its pre-determined specifications and quality attributes.
Validation can be re-stated as a means of proving that the requirements for a system have been :
Defined in advance, and that the system has been tested to prove that these requirements have been met and proof that each step has been completed by objective evidence in the form of documentation.
GAMP : Good Automated Manufacturing Practice is a "How to Guide" for the validation of computer systems. It contains seperate requirements for suppliers of systems and users of systems. It was developed as each company, and indeed each project team within a company, tended to apply personal preference rather than a methodology for compliance. GAMP provides, supplies with a universal standard that would meet the requirements of the pharma industry.
- 21 CFR Part - 11 is another requirement if the validation requirement is not maintained on paper. It can be summarized as "The final rule that provides criteria under which FDA will consider electronic records to be equivalent to paper records andelectronic signatures equivalent to traditional hand written signatures".