Meeting regulatory requirements in the pharmaceutical, medical device and biotechnology industries is a complex undertaking. Companies must adhere to strict guidelines like 21 CFR Part 11, which governs electronic records and signatures.
Maintaining compliance with regulations like 21 CFR Part 11 is a continuous responsibility for pharmaceutical, medical device and biotech companies.
This blog details the advantages of electronic records for compliance and explains how Sepha’s systems support this transition.
This blog explains how Sepha’s products are designed to meet strict pharmaceutical data integrity standards (ALCOA+) to ensure quality, compliance, and patient safety.
This blog post explains the intent of 21 CFR Part 11, why it matters, and how it affects operations in regulated industries.
What Data Integrity, Speed and Package Integrity Mean for Manufacturers and CDMOs. A Q&A with Claire Miskelly, Head of Sales at Sepha
