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Principle Data Collection Data Correction Signatures Falsification of Documentation

Note: This training material only covers key topics related to GDP for the purpose of NHO training. For complete GDP details, please refer to  QSP V-QMS-0053974 .

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Data is collected, recorded and retained using ALCOA+ principle to ensure the data is complete, consistent and accurate.

Who performed an action and when? If a record is changed, who did it and why? Link to the source data.

Data must be recorded permanently in a durable medium and be readable.

The data should be recorded at the time the work is performed

Is the information the original record or a certified true copy?

No errors or editing performed without documented amendments

All data, including metadata are present. No omission of data

Data are readable and retrievable in its lifetime.

Data are available and accessible when needed.

Data should not vary and non-contradictory

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Use  only the most  Recent Effective  version of forms . DO  NOT  pre-print the forms . DO  NOT  record data on informal place for later transcription, for example, record on Post-it notes, scratch pad, your hand, etc.  Forms

Blue   ballpoint pen is recommended . DO  NOT  use gel pens because of their potential to smear . DO  NOT  use pencils because entries made could be erased . Legible  penmanship to prevent misinterpretation of data . Permanent Ink Example of illegible penmanship

Blank fields  must  be marked  “N/A ”  to indicate it was not skipped or missed . To  cross out an entire section 1. Use a single diagonal line. 2. Write N/A near the line. 3. Initial, sign and date. 4. Include explanation for N/A if the reason for non-applicability is not obvious . Blank Fields

Record  every entry . DO  NOT  use ditto marks (“ ”) or arrows . Repetitive Entries

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The associate who made original entry, makes the correction . Another person can help to make correction  only if error is obvious or info retrievable from raw data and source identified in explanation.  Who

Strike through the error . Make the correction next to the error. Mark an asterisk (*) beside error. Select an appropriate correction code . Initial and Sign, Date. Use the  date the correction is made , not the date the error was made. Date format should always be  DD-MMM-YYYY . How

DO NOT  delete, cancel, erase or make original data entry illegible . DO NOT  use correction tape or correction fluid . DON’Ts

This is to ensure that all corrections are  attributable . What are the errors? Who performed it?

Correction Codes Refer to V-QMS-0084625  for  this table of reason codes.

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Notes:  - Corrections  to multiple errors to be stated  sequentially. - Numbering  of asterisks starts anew on a fresh  page.

Steps:  Strike  through the error . Make the correction next to the error. Mark an asterisk (*) beside error. Select an appropriate correction code . Initial and Sign, Date. Use the  date the correction is made , not the date the error was made. Date format should always be  DD-MMM-YYYY .

4.3
5.
By signing. it is confirmed that the packaging
data and information have bæn reviewed.
SCRAP
v/ NIA (Tick if lot is not scrapM
PR Closure Date:
by SP
by SP associate:
Reviewed by Lot release associate:
Material Doc

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Format Initial/ Sign/  Date (Manual aka wet  s ignature) Initial/Date alone is  Not  considered as a Signature . All AML associates has their own unique initial and signature  documented to  ensure traceability of identities .

Types Manual  (wet) signature Electronic  signature – Password or PIN required to perform the e-signature

Signature Labels Performed By:  I did it Verified By :  I saw  it or I  checked  it Reviewed  By:  I confirmed  it Approved By :  I agree with  it Note: One person can only assume One Role. If  2 individuals are performing an activity, both must sign as “Performed By ”.

DOs & DON’Ts Only sign/date your  own  name for work completed.  S ignature  must be performed contemporaneously with the date of  signing.  Do Not  backdate.  Do N ot  disclose or share your password or PIN used for e-signature or use  someone's  e-signature.  Do Not  perform and then approve, verify, or review the same data or information .

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Falsifying  data  is the act of willfully record false or misleading data. It is  a violation of Alcon policy, is strictly prohibited, and may be grounds for termination. E xamples  of  document falsification: Fabricating  information or recording results without performing the work.  Back dating or future dating of entries.  Signing another person’s name to a document.  Manipulating the clock  on a computerized system  to  misrepresent the actual date or time.

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Good  documentation practice shows control over our products and  processes . Therefore,  Take your time when perform any tasks. Always  verify  your own work before sending for review. Do it right at the first time.  Do not  leave  documentation error as it will get worse later. Take the time to correct it and document the correction properly.  Always  ASK  when in doubt. It is far better to ask questions than to try to fix the issue later on.

Good Documentation Practices (GDP)

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