SeerPharma Blog

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...

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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...

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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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GMP Validation Assistance to Multinational Pharmaceutical Company

August 17, 2016

SeerPharma assists a multinational pharmaceutical company with on-site GMP validation activities.

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CSV Support for Medical Device Manufacturer

April 29, 2016

A major Australian manufacturer of medical devices has engaged with SeerPharma to deliver a customised program on computer system validation (CSV). The course looks to address content such as agile processes, cloud computing and automated testing drawing on SeerPharma’s experience with the regulatory (GMP) framework and incorporating case...

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Effective CSV in the Pharmaceutical / Medical Device Industry

February 26, 2016

You’re a Quality, IT, or Operational manager working for a Pharmaceutical / Medical Device company, responsible for the computer systems used in-house. Working in the Pharmaceutical / Medical Device industry, means that regulators such as the FDA and TGA will scrutinise the use and validation of these business critical systems.

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