A draft guidance of Computer Software Assurance (CSA) for Production and Quality System Software has been issued by the FDA this week. This is a […]
Looking for an opportunity in Life Sciences? Willing to be part of our team of consultants? Check this out! OPEN POSITIONS: Mid-senior & Junior […]
In July 2022 ISPE issued the second edition of the GAMP 5 guide. Since the issuance of the first edition in 2008, multiple changes have occurred […]