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ALCOA & ALCOA+

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Guru Balaji .S
Guru Balaji .S

ALCOA & ALCOA+ #health #medicine #research #manufacturing #innovation #research #development #Healthcare #quality #pharmacist #technology #CRO #compliance #counterfeits #gurubalaji

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ALCOA s.gurubalaji@gmail.com
ALCOA Attributable Who performed an action and when? If a record is changed, who did it and why? Link to the source data Who did it ? Source data Legible Data must be recorded permanently in a durable medium and be readable Can you read it? Permanently recorded Contemporaneous The data should be recorded at the time the work is performed and date / time stamps should follow in order was it done in ¡°real time¡±? Original Is the information the original record or a certified true copy? Is it original or true copy? Accurate No errors or editing performed without documented amendments It is accurate ? s.gurubalaji@gmail.com
ALCOA + s.gurubalaji@gmail.com
ALCOA + Complete All data including repeat or reanalysis performed on the sample 21 CFR 211.194 Consistent Consistent application of data time stamps in the expected sequence Date time stamps Enduring Recorded on controlled worksheets ,laboratory note books or electronic media Medium used to record data Available Available/ accessible for review /audit for the life time of the record For the life time of the record s.gurubalaji@gmail.com

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ALCOA & ALCOA+

  • 2. ALCOA Attributable Who performed an action and when? If a record is changed, who did it and why? Link to the source data Who did it ? Source data Legible Data must be recorded permanently in a durable medium and be readable Can you read it? Permanently recorded Contemporaneous The data should be recorded at the time the work is performed and date / time stamps should follow in order was it done in ¡°real time¡±? Original Is the information the original record or a certified true copy? Is it original or true copy? Accurate No errors or editing performed without documented amendments It is accurate ? s.gurubalaji@gmail.com
  • 4. ALCOA + Complete All data including repeat or reanalysis performed on the sample 21 CFR 211.194 Consistent Consistent application of data time stamps in the expected sequence Date time stamps Enduring Recorded on controlled worksheets ,laboratory note books or electronic media Medium used to record data Available Available/ accessible for review /audit for the life time of the record For the life time of the record s.gurubalaji@gmail.com