The advanced regulated markets – United States of America, Europe, Japan, and others are opening up for pharmaceutical companies of other countries to export their products to above advanced markets under certain conditions & Guidelines. The conditions & Guide lines are issued from time to time by each of these countries. For example United States of America’s guidelines for compliance of electronic data to support CFR 210 & 211 is referred as CFR 21 Part 11 of USFDA.

Hence it is mandatory to comply with above guidelines before the inspection by Regulatory Agencies. During the inspection it is important to have the computer system (Application, Hardware, communication & data storage) also reviewed & validated.

Why System Validation?

Most companies are investing in Information Technology (IT) enabled applications to improve their operational performance on one hand. On the other hand, electronic data like Quality Analysis, Certificate of Analysis (COA), Material Quarantine, Retest, Reprocessed, Non-Conformity Material Disposition Record (NCMDR), Equipment & Instrument Calibration, Bill of Material (BOM), Recipe and Machine History records captured in IT enabled applications helps in accelerating the audit process as details of compliance to current Good Practices (cGxP) {x - Manufacturing (M), Clinical (C) and Laboratory (L)}, and adherence to Standard Operating Procedures (SOP) can be easily checked in rapid time, hence considerably reducing the audit time.

Data, referred to in the above paragraph, if made available to the audit agencies in validated systems, considerably enhances the confidence of the agencies, as well as customers in the advanced regulated markets. Hence, a systematic validation of the IT applications and systems involving the Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) has become critical to a company’s success.

SpectraSoft has done System validation in a number of companies who have all been audited and approved by USFDA.

SpectraSoft helps company establish systems and processes and enable them to comply with Regulatory Requirements.

Getting started

If your company is in need of Validation you can call for further information or contact us for taking it forward.