Validating pharmaceutical systems
The data with some of the highest concerns for risk in cloud environments includes records pertaining to quality systems in pharmaceutical manufacturing.
Company requirements in these industries are extremely tight on computer system validation due to the need to stand up to the rigor of regulators.
COTS software Traditionally, most pharmaceutical companies deploy on-premise software.
They may purchase a commercial off-the-shelf (COTS) system, install it internally on servers, configure it to communicate on the corporate network and with other corporate systems and databases, and manage it in compliance with a corporate IT strategy and set of Standard Operating Procedures (SOPs).
Proper training record with attendance should be maintained.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.
Mitigating risks and avoiding new ones is top of mind for pharmaceutical IT and quality professionals.
Now that cloud-computing models are well accepted across many industries with proven security models and high reliability, it is becoming a viable option for life sciences enterprises.
However, the nagging challenge of validation of these systems is still widely misunderstood among life sciences professionals.
Therefore, HPLC is taken as an example system for validation.
Computer system validation protocol can be written in following steps.1.
Computer system validation creates confusion for many pharmaceutical professionals because there are two things one is computer and other the instrument software. Note: When computers are connected by means of local area network (LAN) it should be included in operational qualification.