In software development for regulated industries, ensuring compliance with regulations such as 21 CFR Part 11 and EU Annex 11 requires a systematic and structured approach. In this blog, we explore how adhering to the principles of ISPE GAMP® 5, can guide software providers in aligning their activities to ensure …

Network design has always played a critical role in ensuring seamless operations in Biotech.  However, data security and reliable communication are often at odds with each other. Sites, which include laboratories, research facilities, and manufacturing plants, demand specialized network infrastructures to support their research, maintain sensitive data, and a myriad …

For FDA-regulated pharma and biotech companies, computer systems used in GxP environments must adhere to Electronic Records and Electronic Signatures (ERES) requirements, as governed by FDA 21 CFR Part 11 to ensure data integrity, product quality, and patient safety. Computer systems that create, modify, maintain, archive, retrieve, or transmit records …