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...
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.
The Philippine Chamber of Pharmaceutical Industries (PCPI) was born in 2004 from the merger of four different associations, the Chamber of Filipino Drug Manufacturers and Distributors, the Association of Drug Industries of the Philippines, the Filipino Drug Association, and the Association of Philippine Pharmaceutical Manufacturers.
BioMelbourne Network is a not-for-profit membership association for organisations engaged in biotechnology, medical technology, pharmaceuticals and health innovation in the State of Victoria, Australia. It plays a critical role in connecting clinicians, researchers, finance and industry. The Network routinely hold events looking to connect...
A multinational pharmaceutical contract manufacturer recently required the assistance of a senior pharmaceutical QA resource to assist with managing Quality and GMP issues at their manufacturing site.
SeerPharma’s Software Solutions team has been engaged to implement an electronic Quality Management System (eQMS) for a major multinational pharmaceutical company.
A number of firms have requested our expertise to provide technical and compliance audits of contract manufacturers that they currently use in Europe and Asia.
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’s inaugural Symposium was a great success with Operational and Quality Directors from over 30 Pharmaceutical and Medical Device / Medical Technology companies such as CSL, Patheon, Alere Medical and MSD in the crowd.
GMP Data Integrity is an issue that a number of our clients have approached us about recently. The concept of Data Integrity has been around for quite some time, with the TGA introducing the concept of electronic records in to the previous Australian code of GMP back in 1990, while the FDA made 21 CFR Part 11 Electronic records and signatures...