Ensuring Data Integrity: Alcoa++ demonstrated for Pharma Industry

[@sureshmolakalapalli]

Thank you sir for very good explanation, In some situations operator not possible to enter manual data entries contemporaneously at the time of activity, In that scenario how data entered contemporaneously.

[@PharmaQuality23]

There are several ways to act on such situation based on the Quality head approval, few examples are below: 1. Assign the IPQA/Lab QA person to record the data along with operator and there should be the justification for such situation. 2. Some approved paper-based logs or annexure can be used to quickly enter the data and later can transcribed into data sheet/BMR etc. 3. If automated system is there then voicing recognition software can use to interface the data into the original software. And many more...

[@Rakesh-wj9vn]

Sir can you please forward the links in which we can download WHO ,GMP ,EU annex and FDA guidelines for manufacturing vaccine facilities... Please

[@PharmaQuality23]

cdn.who.int/media/docs/default-source/biologicals/gmp/annex-2-who-good-manufacturing-practices-for-biological-products.pdf?sfvrsn=995d5518_2&download=true#:~:text=URL%3A%20https%3A%2F%2Fcdn.who.int%2Fmedia%2Fdocs%2Fdefault www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice www.fda.gov/vaccines-blood-biologics/biologics-guidances/vaccine-and-related-biological-product-guidances