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The ALCOA principles ensure data integrity. They apply to the following types of GMP records: Electronically recorded – data recorded using equipment that ranges from simple machines through to complex and highly configurable computerised systems; Paper-based – a manual recording on paper of a manual observation or of an activity. Dec 16, 2019 Alcoa Corporation, a global leader in bauxite, alumina, and aluminum products, today announced that it will permanently close its Point Comfort alumina refinery in Texas. The site’s 2.3 million metric tons of annual alumina capacity has been fully curtailed since June of 2016. In October of 2019, Alcoa announced that it was conducting a review of its global production capacities to drive. Alcoa Corporation, a global leader in bauxite, alumina, and aluminum products, today announced that it will permanently close its Point Comfort alumina refinery in Texas. The site’s 2.3 million metric tons of annual alumina capacity has been fully curtailed since June of 2016. In October of 2019, Alcoa announced that it was conducting a review of its global production capacities to drive.
Since 1888, the people of Alcoa have partnered to create innovative and sustainable solutions that move the world forward. We created the aluminum industry, and will continue to define and advance it.
ALCOA+ is a framework or set of principles that ensures data integrity. It was introduced by, and is still used by, the FDA – the US Food and Drug Administration. It has relevance in a range of areas particularly in relation to pharmaceutical research, manufacturing, testing, and the supply chain.
As well as being essential for compliance reasons, the ALCOA+ principles are becoming increasingly important to GMP (Good Manufacturing Practices).
The Importance of Data Integrity
Data has always been important in pharmaceutical manufacturing and research. A range of different factors, however, means the importance of data is growing exponentially. The drivers for this include enhanced regulatory requirements in addition to the evolving expectations of consumers and end users as well as the increasingly competitive nature of the pharmaceutical industry.
You can’t just have data, though. Instead, you need to have data and you need to ensure the integrity of that data. When you have this, you have data you can use and rely on.
The ALCOA principles ensure data integrity. They apply to the following types of GMP records:
- Electronically recorded – data recorded using equipment that ranges from simple machines through to complex and highly configurable computerised systems
- Paper-based – a manual recording on paper of a manual observation or of an activity
- Hybrid – where both paper-based and electronic records constitute the original record
- Others – this includes photography, images, chromatography plates, and more
The ALCOA Principles
ALCOA is an acronym for the original five principles of data integrity. Those principles are:
- Attributable
- Legible
- Contemporaneous
- Original
- Accurate
However, the original ALCOA principles have since been updated to ALCOA+. The original principles remain with four additions:
- Complete
- Consistent
- Enduring
- Available
Let’s look at each of the principles in more detail.
Attributable
When creating a record, you must record the identity of the person or computer system that collected or generated the data. It’s also important to record the date of the collection or generation.
Legible
Ensuring data is legible is about more than being able to clearly read the data, although that is important in situations where manual data record-keeping takes place. Being able to make out the words is much less of a problem with electronic data, though.
That said, ensuring data is legible still has relevance. This is because it must be possible for data to be read and understood years and even decades after it’s recorded. This can have as much relevance to digitally recorded data as it does to data recorded in notebooks.
In other words, it’s important to avoid using clichés and unusual phraseology as this may be difficult to decipher in the future without getting clarification from the originator of the data, a person who may no longer be available.
Using consistent, straightforward language throughout an entire organisation, regardless of locality, is the best approach.
Contemporaneous
It’s essential that individuals or systems make a record of an activity at the time it takes place. With electronic data, this is normal practice, so this is another point that has more relevance to manual record-keeping.
Original
Records should be original rather than copies or transcriptions. Again, this applies mostly to manual record-keeping. For example, you should not write a record on a scrap of paper with the intention of completing the main record later, as this can result in errors.
Instead, the original recording of the data should be on the main record, whether that record is on paper or on a digital system.
Accurate
All records should reflect the reality of what happened and should be error free. Also, there should be no editing of the original information that results in that information being lost.
If changes are necessary, those changes must be documented in a way that makes it possible to refer back to the original information. Nothing should be removed, blocked out, or deleted.
When recording data electronically, the system must have built-in accuracy checks and verification controls.
Complete
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All recorded data requires an audit trail to show nothing has been deleted or lost.
Consistent
This primarily means ensuring data is chronological, i.e. has a date and time stamp that is in the expected sequence.
Enduring
While this is touched on in a previous principle, this principle of ALCOA+ places specific emphasis on ensuring data is available long after it is recorded – decades in some situations.
Available
This point follows on from the last point, i.e. data must not only exist, it must be accessible. The most efficient way of achieving this is normally by recording data electronically.
Data Integrity and Validation
Data integrity is essential to all validation processes in pharmaceutical and medical device manufacturing facilities. Following the ALCOA+ principles is the best way to achieve this goal.
125 Furrow Way,TN 37701Alcoa
Overview |
Tru By Hilton Alcoa Knoxville Airport, Tn is offering accommodation in Alcoa. The accommodation provides a fitness centre, a 24-hour front desk and free WiFi.
All units in the hotel are equipped with a TV.
Guests at Tru By Hilton Alcoa Knoxville Airport, Tn can enjoy an American breakfast.
Knoxville is 19 km from the accommodation, while Townsend is 33 km away. The nearest airport is McGhee Tyson Airport, 1 km from Tru By Hilton Alcoa Knoxville Airport, Tn.
Kuwarto: 6
Hotel Chain: Tru by Hilton
Ano ang araw ng iyong paglalagi?
Mga Pasilidad ng Tru By Hilton Alcoa Knoxville Airport, Tn
Pool at wellness
- Fitness center
Mga serbisyo sa reception
- 24-hour Front Desk
Iba pa
- Non-smoking na mga kuwarto
- Family room
- Naka-air condition
Safety features
- Sinusunod ng staff ang lahat ng safety protocol na ipinapatupad ng local authorities
- Available ang first aid kit
- Available ang face masks para sa mga guest
Social distancing
- Contactless na pag-check in/pag-check out
- Sumusunod sa mga patakaran sa social distancing
Kalinisan at disinfection
- Gumagamit ng cleaning chemicals na epektibo laban sa Coronavirus (COVID-19)
- Nilalabhan ang linens, towels, at iba pang gamit ayon sa local authority guidelines
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- Na-disinfect ang guest accommodation bago at pagkatapos ng bawat stay
- Naka-seal ang guest accommodation pagkatapos linisin
Ligtas na pagkain at inumin
- May social distancing sa mga dining area
Internet
Ang Wi-fi ay available sa mga kuwarto ng hotel at walang bayad.
Paradahan
Libre't pampubliko, may paradahang makikita (imposible ang reservation).
Mga Patakaran ng Tru By Hilton Alcoa Knoxville Airport, Tn
Ito ang mga pangkalahatang patakaran ng hotel para sa Tru By Hilton Alcoa Knoxville Airport, Tn. Maaari silang magbago batay sa uri ng kuwarto; mangyaring tingnan din ang mga kondisyon ng kuwarto.
Pagkansela / Prepayment
Magkakaiba depende sa uri ng accommodation ang cancellation at prepayment policy.
Mga bata at karagdagang kama
Libre!Hanggang tatlong mga batang wala pang 18 taong gulang ay pwedeng manatili nang libre kapag may existing bed.
May kapasidad na walang extrang kama sa kuwarto.
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Ang maximum capacity ng lahat ng bisitang nasa kuwarto ay 4.
May kapasidad na walang higaan sa kuwarto.
Alagang hayop
Hindi pinapayagan ang alagang hayop .
Mga grupo
Kapag ang booking ay mahigit 9 mga kuwarto, iba't-ibang patakaran at karagdagang suplemento ang maaaring mag-apply.
Mga tinatanggap na credit card
- Mastercard
- Visa
- UnionPay credit card
- UnionPay debit card
- Discover
- JCB
- Diners Club
- American Express
May karapatan ang accommodation sa pagpre-authorize ng mga credit card bago ang pagdating.
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