Biotage® Extrahera™ GLP Software and 21 CFR Part 11 Regulations Technical Information

An increasing number of laboratories are using electronic records (ER) and electronic signatures (ES) for exchanging and storing data. Electronic documentation offers many benefits, including increased efficiency and productivity when storing data and easier information sharing and data mining. If a company or laboratory intends to use an electronic format instead of paper for records that are required under FDA regulations and requirements, the company or laboratory must comply with the regulations issued by the FDA: Final Rule 21 CFR Part 11 Electronic Records.