As a life sciences manufacturer, there’s mounting pressure to integrate artificial intelligence (AI) across the product lifecycle and capitalize on the opportunities this technology presents to the industry. Organizations face the complex challenge of balancing innovation with regulatory compliance.
Safe and effective adoption of AI can require...
Audit trails play a crucial role in ensuring data integrity, traceability and compliance with Good Manufacturing Practice (GMP) regulations. Under the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009-16), Annex 11 outlines specific requirements for computerised systems, emphasising the need for audit trail reviews....
SeerPharma has been at the forefront of delivering GMP Training to the Pharmaceutical and Medical Device industries since the 1990s. With a constant view to the future, SeerPharma pioneered its own eLearning solution for industry and developed a Learning Management System (LMS) that hosted GMP eLearning courses and assessments. The solution was...
Data Integrity (DI) has become a common issue and a key area of focus for regulators in our industry. Trust is at the cornerstone of relations between industry, regulatory bodies, the health sector, and patients(consumer). Data is evidence of the activity that has been performed. Regulatory bodies entirely rely on the accuracy and completeness of...
A manufacturer of pharmaceuticals in the Asia-Pacific region engaged SeerPharma to deliver an onsite training workshop on Data Integrity to staff involved in Production, Quality and Warehousing.
SeerPharma in partnership with the Life Sciences Industry Group of the SingaporeManufacturing Federation held its annual Symposium for 2017 in Singapore, March 16th to 17th. The event saw over 50 delegates from across the Asia-Pacific region attend. Companies from countries such as The Philippines, Malaysia, Singapore, Australia and Sri Lanka were
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...
Cynata Therapeutics Limited is an Australian stem cell and regenerative medicine company that is developing a therapeutic stem cell platform technology, Cymerus™.
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.
Copyright © SeerPharma
