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Pharmaceutical, Life science and healthcare are few of the industries which needs to operate under the scanner of various regulatory and quality bodies. They need to be ready always for rigorous audit sessions to ensure regulatory and quality compliance. In this era of automation most of the brick and mortar companies are using various softwares for various processes like Pharmacovigilance software for recording adverse effects, electronic batch recording software, quality management software, clinical trial management software, training management software, document management software and many more so these systems should be effectively validated periodically and be ready for regulatory inspections. Because regulatory bodies are providing coaching to their audit inspectors about these various software systems so these inspectors are able to inspect more facilities and dig deeper into areas such as Regulatory Complaint CSV – computer system validation.
Regulatory inspections are very necessary for these above mentioned industries because this could affect your authorization to produce any new drug or to launch in a new market. In this context, the preparation and readiness for inspection, including computer system validation, is essential for the success of an inspection.
Complete readiness and preparedness can be explained as the ability to successfully host or execute regulatory inspections of validated computer systems. In other words performing as per the users expectations and GAMP and 21 CFR part 11 guidelines.
The objective of hosting the audit is to ensure that only correct information is disseminated by the most appropriate person in a timely manner.</p.
Sarjen Systems has a team of consultants who can provide strategic support for validation projects as well as day-to-day support for maintenance, revision and verification of activities regarding the computer system validation status and various services which include:
• Periodic compliance review of computerized systems
• Review of IT infrastructure
• Change control management
• Internal and external audit preparation
QEdge Quality Management Software Suite
Contact Us
6th Floor, Arista, 100 Feet Anand Nagar Rd, Jodhpur Village, Ahmedabad, Gujarat 380015
Phone : +91-79-66214899
Email: sarjen@sarjen.com
