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 - Intentional, Unintentional and Potential
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...
Data Integrity Training for Pharmaceutical Manufacturer
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.
Global Perspective on Effective Management of Risk-based GMP
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 Masterclass
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...
Data Security Support for Small Biotech Company
Cynata Therapeutics Limited is an Australian stem cell and regenerative medicine company that is developing a therapeutic stem cell platform technology, Cymerus™.
Effective CSV in the Pharmaceutical / Medical Device Industry
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.