The URS has been initiated by user department, XXX, and pertains to procurement of computer system. TABLE OF CONTENTS Sr. No. Topics Page No. 1.0 APPROVAL 3 2.0 INTRODUCTION 4 3.0 OVERVIEW 4 4.0 HARDWARE REQUIREMENT FOR SYSTEM 4 5.0 SOFTWARE REQUIREMENT FOR SYSTEM 5 6.0 UTILITY REQUIREMENT 5 7.0 ABBREVIATIONS 5 8.0 REMARK 5 […]
SOP For Computerised System Introduction and Validation Read More »
Operational Qualification (OQ) In Pharmaceuticals. Systems and equipment should operate correctly and their operation should be verified in accordance with an operational qualification protocol. Critical operating parameters should be identified. Studies on the critical variables should include conditions encompassing upper and lower operating limits and circumstances (also referred to as “worst case conditions”). Operational qualification
Operational Qualification (OQ) Protocol & Report Format In Pharmaceuticals. Read More »
Common Terms & Definitions used in Qualification & Validation of Heating, Ventilation and Air-Conditioning Systems For Non-Sterile Pharmaceutical Dosage Forms. Design parameters should be set realistically for each project, with a view to creating a cost-effective design, yet still complying with all regulatory standards and ensuring that product quality and safety are not compromised.
