The Basic Regulatory Expectations (Requirements) of Using Digital Health Technology for Clinical Studies

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 12, Seite 1393 (2022))

Meng B

The Basic Regulatory Expectations (Requirements) of Using Digital Health Technology for Clinical Studies / Meng • DHT for Clinical Studies · Meng B · Ulm
The COVID pandemic has changed the world and daily life totally. However, this changing is not only in a negative sense, but also in some positive way, e.g., rapidly digitalizing our working and living way. The decentralized clinical trial with the aid of Digital Health Technology (DHT) has become even more important for many pharmaceutical research and development (R&D) organizations. The regulatory authorities have also realized the rapid digital transformation of clinical development and published regulations for using DHT in clinical investigations, e.g., the U.S. Food and Drug Administration (FDA) draft guidance “Digital Health Technologies for Remote Data Acquisition in ...

Finding a way to incorporate quality risk management into quality system management

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 03, Seite 338 (2019))

Meng B

Finding a way to incorporate quality risk management into quality system management / Meng • Quality risk management · Meng B · Ulm
The ICH guidance Q9 and Q10 has been effective for more than 10 years now. Performing risk assessments according to ICH Q9 has already become a routine business in the pharmaceutical area. However, many pharmaceutical companies are still struggling to find an effective and reasonable way to incorporate the quality risk management into the quality system and operation activities. The current ISO 9001:2015 is going on to address the risk-based thinking and make it more explicit, which should be built into the whole quality management system. Risks are not regarded as negative senses, instead they provide opportunities to prevent or reduce undesired effects ...

Is Data Better to Track with TrackWise than with a Paper-based System?

Rubrik: GMP / GLP / GCP

(Treffer aus pharmind, Nr. 05, Seite 618 (2018))

Meng B

Is Data Better to Track with TrackWise than with a Paper-based System? / Comparison between an E-System and a Paper-based QM System · Meng B · Ulm
In April 2016, the FDA released the draft guidance “data integrity and compliance with cGMP guidance for industry”. Data integrity has acquired even more of a key role during inspections and audits. Not only would American inspectors like to take a closer look into the data management systems, but also European authorities and organizations pay more attention to this point. In August 2016 the Pharmaceutical Inspection Co-operation Scheme (PIC/S) published the draft guidance “good practices for data management and integrity in regulated GMP/GDP environments” in which it states that “Data Integrity is defined as ‘the extent to which all data ...