what is the difference between iso 13485 and 21 cfr 820?

Keep a permanent record of all cell formulas when the spreadsheet has been developed.

Test the spreadsheet by entering nonsensical data.

Manually verify spreadsheet calculations by entering data at extreme and expected values.

Automatically reject data outside valid ranges.

Make spreadsheets read-only, with password protection, so that only authorized users can alter the spreadsheet.

Lock all cells of a spreadsheet, except those for data input.

Some Suggested Validation Measures from the FDA: There is a common misconception that only spreadsheets with formulas must be validated. However, even a data processing system (spreadsheet or database) that holds records must be validated if it is part of the quality system. If the spreadsheet supports a process that is governed by external regulations and quality standard requirements, it should undergo the validation process. 21 CFR Part 11 states that the purpose of validation is to “ensure accuracy, reliability, consistent intended performance, and ability to discern invalid or altered records.” Validation produces documented evidence that the spreadsheet performs its intended use correctly and consistently, while verification ensures that the correct output is achieved Spreadsheets and databases are automated data processing systems under regulation 21 CFR Part 820.70(i) and if they are used as part of production or the quality system, they need to be validated for their intended use. The quality system must have written SOPs and the validation must be documented and maintained. ISO 13485:2016 explicitly mandates that software used as part of the quality system be validated and subject to change control. These validation activities and results shall be documented.” All software changes shall be validated before approval and issuance. If your company has received warnings from the FDA or you are looking to implement a verification and validation SOP, AlvaMed has the experience and expertise to help.Ģ1 CFR 820.70(i) – “When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol. Released in March of 2016, ISO 13485:2016 will require the validation of software which will now align with 21 CFR 820. Many companies have received warnings from the FDA about their lack of validation procedures on their data processing systems. In the recent years as computers and software have become increasingly vital and complex, the FDA has become more stringent on software, database, and spreadsheet validation with new regulations upon us other notifying bodies will follow suit.

What is the difference between iso 13485 and 21 cfr 820?