Good Documentation Practices are critical within organizations implementing a controlled document system. With an emphasis on maintaining a system of control, participants will learn strategies, standards, and practices for accurately completing controlled documents in a cGMP work environment. In addition, participants will learn to implement ALCOA, an acronym for a method used to ensure information is properly collected, recorded, and stored.
Examples of documents discussed include Standard Operating procedures, Work Instructions, Batch and Test Records, Forms, and key documents central to many types of processes. Requirements of 21 CFR 11, Electronic Records; Electronic Signatures, will also be addressed.
This course reviews strategies for implementing compliance, as well as standards and practices for accurately completing cGMP paper records. Participants in this course will:
• Learn why Good Documentation Practices are essential to a Quality Management system
• Apply the ALCOA system to Good Documentation Practices
• Identify applications and differences between procedures, records, forms, and other controlled documents
• Distinguish between correct and incorrect completion of records and forms
• Understand the Requirements of 21 CFR 11, Electronic Records: Electronic Signatures
This course is available online, and can be taken anytime, anywhere.