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life science industry life science pharma life sciences consultancy pharmaceutical industry life sciences industry fda pharmaceutical european union medical devices european legislation healthcare medical device regulations regulatory compliance data integrity general data protection regulation ema gdpr gmp medical device directive pi life sciences consultancy data legislation data privacy big data quality metrics program data data security usp compliance ispe european medical device regulations manufacturing pharmacovigilance analytical instrument qualification elemental impurities aiq good manufacturing practices healthcare consulting pi data law international law samd software as a medical device medical software regulatory affaires regulatory performance qualification operational qualification installation qualification pharmacopeia nir infrared spectroscopy near-infrared spectroscopy instrument qualifiation ich q2: validation of analytical procedures analytical procedure transfer analytical procedure verification analytical procedure validation analytical lifecycle analytical target profile automation continuous manufacturing patient centered healthcare patient centred healthcare internet of things personal data europe instrument qualification data quality ich ich q3d guideline privacy by design european commission quality metrics fdasia vigilance medical device vigilance medicine production product quality assessment who signal detection idmp iso result review review process review by exception data audit periodic review audit trail review data integrity compliance soft skills data integrity audit data life cycle data lifecycle ivdr eu mhra alcoa strategic consultancy consulting services active implantable medical device directive mdr