Which statement best describes the common requirement for archives and the quality assurance unit?

• A. Both areas require written standard operating procedures to govern their operations.
• B. Archives require SOPs, QA unit does not.
• C. QA unit requires SOPs, archives do not.
• D. Neither requires SOPs.

Answer: (A)

Written procedures guide how tasks are done, keeping activities predictable, compliant, and traceable in a regulated lab. Archives manage records and need SOPs to define how records are created, stored, retained, and retrieved. The quality assurance unit also relies on SOPs to standardize audits, investigations, and corrective actions so they are performed consistently each time. Because both areas depend on clear, formal guidance to ensure uniform practice and proper documentation, the statement that both require written SOPs best describes the common requirement. If one area or neither had SOPs, essential processes wouldn’t have consistent, approved instructions, which would undermine quality and regulatory compliance.