Why Choose Reliant FDA Experts?

SOP Generation

A good SOP is much more than just compliant. It should also be clear, easy to follow, and utilize links to other SOPs rather than repeat information. An SOP that does this will help ensure that an auditor doesn’t find inconsistencies between SOPs, or ask a question that requires consulting a team of people to come up with an answer. It will also help ensure the auditor doesn’t find instances where SOPs were not followed because everyone assumed someone else was responsible. Last but certainly not least, a good SOP is cleanly formatted and grammatically correct. This helps keep the auditor moving rather than digging further on the assumption that things were rushed and not reviewed properly.

SOP SECTIONS IN A TYPICAL TEMPLATE

  • Purpose
  • Scope
  • Responsibilities
  • Definitions
  • Materials
  • Procedure
  • References
  • Revision History

COMMON ISSUES, MISTAKES AND PITFALLS

  • Not having clearly defined responsibilities
  • Insufficient detail for consistency between personnel
  • Repetition of specific procedure details in multiple SOPs
  • Absence of definitions required for clarity

EXAMPLES OF THE HELP RELIANT CAN PROVIDE

  • Generation of SOPs, Forms, and Templates
  • Audit, Assess, and Provide Recommendations on an Existing SOPs, Forms, and Templates

ASSOCIATED JOURNAL ARTICLES AND COMPLIANCE TIPS
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