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The latest revision of ICH E6 (R3), finalised in January 2025 and enforced in Europe since 23 July 2025, marks a significant shift in clinical trial governance, moving beyond incremental updates to reflect modern trial practices and technologies. The guideline emphasises quality by design, risk-based proportionality, and clearer delineation of...

With the mainstream support for SAP ECC6 ending in 2027 and extended maintenance available only until 2030 at an additional cost, Pharmaceutical and Medical Device manufacturers are facing a critical decision: how to upgrade their ERP systems in a way that meets both business goals and regulatory obligations. The move to SAP S/4HANA presents a...

SeerPharma has been engaged by a major multinational manufacturer to provide guidance and support on Computer System Validation (CSV) for a digital migration project. Based in Singapore this company has a global client base of leading companies in the Life Sciences and Medical industry. The client is heavily involved in the design and manufacture...

VIMTA is a leading contract research and testing organisation headquartered in India, serving the pharmaceutical, food, and general manufacturing sectors. With over 40 years of experience and a global presence, VIMTA is at the forefront of supporting pharmaceutical companies with their outsourced product development and discovery activities.

KENX is a leading knowledge exchange network in the life sciences industry, at the forefront of coordinating and running events focused on making pharmaceuticals and devices safer. The organisation achieves this by bringing together regulators and industry leaders to address the latest industry trends, regulatory changes, business challenges and...

The Singaporean division of a global diagnostics equipment manufacturer engaged SeerPharma to deliver training on Computer Software Assurance/Validation and 21 CFR Part 11. Multiple workshops were delivered to over 50 staff, to help them appreciate the regulatory expectations of the US FDA , for the work performed on-site.

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 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.