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...
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...
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...
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...
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 ?
SeerPharma’s Software Solutions team has been engaged to implement an electronic Quality Management System (eQMS) for a major multinational pharmaceutical company.
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.
SeerPharma assists a multinational pharmaceutical company with on-site GMP validation activities.
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 studies...
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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