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SeerPharma to Present at KENX CSV/CSA University in San Diego

November 09, 2023

KENX is a leading knowledge exchange network in the life sciences industry, at the forefront of coordinating and running events focused on making pharmaceuticals and devices safer. The organisation achieves this by bringing together regulators and industry leaders to address the latest industry trends, regulatory changes, business challenges and...

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CSA/CSV & 21 CFR Part 11 Training for Global Diagnostics Manufacturer

July 03, 2023

The Singaporean division of a global diagnostics equipment manufacturer engaged SeerPharma to deliver training on Computer Software Assurance/Validation and 21 CFR Part 11. Multiple workshops were delivered to over 50 staff, to help them appreciate the regulatory expectations of the US FDA , for the work performed on-site.

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Computer Software Assurance (CSA) Webinar for ISPE India

October 13, 2021

The International Society for Pharmaceutical Engineering (ISPE) is a global not-for-profit association serving its members involved across the entire pharmaceutical product lifecycle. Affiliates and Chapters of the ISPE can be found around the world.

ISPE India, the Indian affiliate of ISPE, recently invited SeerPharma's Director – Ian Lucas, to...

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Computer Software Assurance (CSA)

June 17, 2020

Computerised System Validation (CSV) is an activity carried out by Pharmaceutical and Medical Device organisations to ensure that IT infrastructure and applications that impact product quality are operating in a controlled state. Organisations must demonstrate an appropriate level of control of their Computer Systems to regulators such as the US...

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CSV Assistance for Pharmaceutical and Medical Device Companies

December 09, 2019

Several pharmaceutical and medical device manufacturers in the Asia-Pacific region have approached and engaged SeerPharma for assistance on matters related to Computer System Validation (CSV). Typical requests have seen SeerPharma address computer systems validation approaches to meet the regulatory requirements of Annex 11 of the PIC/S Guide to...

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CSV Review of Applications & Practices for Pharmaceutical Manufacturer

August 26, 2019

A Pharmaceutical manufacturer has requested that SeerPharma conduct a Computer System Validation (CSV) review of their level of Good Manufacturing Practice (GMP) compliance around the activities and functions of their IT department. The CSV review will help provide confidence that their computerised system are in a Validated state.

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Computer System Validation (CSV) Workshop In Hong Kong

November 30, 2018

A major provider of supply chain and transport solutions in the Pharmaceutical and Medical Device Industry engaged with SeerPharma to deliver a workshop on Computer System Validation (CSV) to their Global Quality Team in Hong Kong. The workshop focused on CSV as it relates to Good Distribution Practices (GDP), looking to address the Why and How of...

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Computer System Validation: Starting on the Right Track

January 18, 2018

Most of us follow a professional sporting team. Each year we start the season with hope and enthusiasm that ‘this year’ will be ‘our year’. Have our recruiters and management assembled the right mix of youth and experience and will they be coached to their strengths? Is the framework in place to raise our odds of success ?

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Electronic Quality Management System (eQMS) for Pharmaceutical Company

December 15, 2016

SeerPharma’s Software Solutions team has been engaged to implement an electronic Quality Management System (eQMS) for a major multinational pharmaceutical company.

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CSV Gap Assessment for Pharmaceutical Distributor

November 15, 2016

A major pharmaceutical distribution organisation engaged the services of SeerPharma (Singapore) Pte Ltd to provide a review on the compliance of its core SAP-Centric solution to the GxP Computer Systems Validation (CSV) requirements of both FDA 21 CFR Part 11 and PIC/S Guide to GMP Annex 11. There were 2 phases to this project.

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