ALCOA Plus USFDA Guidelines

Rahul Kashyap


ALCOA Plus USFDA Guidelines

Data Quality Attributes – ALCOA | ALCOA Plus USFDA Guidelines


•Each entry must be recorded, initialed and dated by the person performing the action

             Sign only for work you have performed or an activity that you have witnessed

             Electronic systems should retain all information as an audit trail

             Keep electronic passwords secret and secure

             Always Log Out or lock your computers when not in use!

Data Quality Attributes – ALCOA


             Electronic data should be easy to read and access

             Handwriting must be legible/readable in records, reports, etc.

             Record all data in permanent ink

             Changes made to data must not obscure/delete the original entry

             Use a single line to cross out and do not use correction fluid for paper records

             Electronic systems must retain all changes through audit trails

ALCOA Plus USFDA Guidelines

Data Quality Attributes – ALCOA

Contemporaneous (Real time)

•Information must be captured at the time of the activity by the person who performed/witnessed it

•Back-dating is never permitted

•Retrospective entry of ‘missing’ information or data must include an explanation, signature/initials and date

•Only use approved forms / documents to record all GMP data

Data Quality Attributes –ALCOA Plus USFDA Guidelines


•Original data (also known as ‘Primary Data’ or ‘Raw Data’) is the first information captured and must never be obscured or removed

•Always check the raw data when reviewing and approving reports or records

•Data must never be deleted and must be accessible throughout its lifetime

•Keep all documents / records (even if it has been invalidated)

•Take appropriate steps when correcting a documentation error to maintain a history of incorrect entries or changes

Data Quality Attributes – ALCOA Plus USFDA Guidelines


•Data must be free from errors with no missing information (including all failing and invalidated results)

•Others must be able to verify the processed/calculated data

•Data entered consistently in the required format (e.g. correct decimal places with the correct units)

•N/A, date and initial any blanks or empty spaces



•We gather a large quantity of data related to our research, manufactured products, testing, and our organisation

•There is a need to continually improve how we gather, manage, store and use our data

•Regulations require our data to be accurate, reliable and traceable throughout its lifecycle

•Need to implement an approach to Data Integrity (DI) that prevents issues, ensures compliance and builds trust

•We need a blame free culture that supports speaking up about concerns


Imagine a customer service representative from your bank calls you to notify you that a large transfer of funds out of your account was successfully completed.

Unfortunately, you never authorized any transfer and are depending on that money to pay pending bills.

After investigation, it turns out that an employee at the bank accidently processed another customer’s transfer against your account because of a few incorrectly transcribed account digits. Moreover, the bank manager approved the transaction without performing proper verification per bank procedures.

The bank promises to correct the situation, but you also now have to follow up on several bill payments that were declined because of insufficient funds.

The bank has apologized, but how would you feel?


Would you continue to trust your bank in the same way after an incident like this one?

If the same type of breach happened at here, would you feel comfortable if a member of your family took the drug or used the product?

•Errors like the bank scenario, in our industry, could have a major impact on the quality of our products.

•Data is part of the product and is a valuable asset:

─Without data, we cannot produce a product!

─Data provides confidence to the person at the end of the supply chain and Health Authorities that products are safe and effective.

Objectives of Data Integrity in pharma | ALCOA Plus USFDA Guidelines

At the end of this session, you should be confident in:

1.            Explaining why Data Integrity is important

2.            Stating 3 consequences of poor Data Integrity

3.            Identifying Data Integrity requirements and your personal accountability

4.            Understanding your role in embedding data integrity into the workplace

What is Data?

◦When you hear the word ‘Data’, what comes to mind?

◦What data do we generate through our day to day activities? Take a moment and list all the different types of data.


Pieces of information that can exist in different forms electronically or on paper. Data can be numbers, text, graphics, audio, pictures, or graphs and can be presented as raw data or as final results and reports. It includes all recorded GMP data such as batch records, logbooks, lab results, notebooks, etc.

Raw data may be on paper that is manually generated and recorded (e.g. IPC checks during production), OR may be generated and stored electronically, such as data produced by lab equipment and captured by a Laboratory Information Management System (LIMS).

What is Data Integrity?

What does Data Integrity mean to you?

Data integrity requirements are not new. FDA, MHRA, and WHO have generated additional guidance to clarify requirements. Why? Numerous violations have been found in recent years that have led to warning letters, import alerts, and consent decrees.

Data Integrity Issues

•Data integrity issues can happen because of unintentional and deliberate behaviours and actions

•Unintentional issues are often the result of poorly designed processes and procedures, mistakes or lack of understanding.

•Deliberate issues are actions to deceive or mislead. These often occur as a result of trying to hide or cover up a mistake or issues. These include:

•Falsification of data, e.g. backdating documents, signing for actions not completed or witnessed

•Omissions or deletion of data

•It is ALWAYS better to explain mistakes or problems openly so they can be resolved quickly and accurately.

•Whether the data integrity issue is unintentional or deliberate, it impacts the safety and quality of our products.

             Even good intentions can lead to poor data

Examples of Data Integrity Issues

A number of data integrity issues result from poor processes or practices, or from high-pressure situations as there is more of a tendency to take short cuts or deviate from the ‘normal process’.

Here are some examples:

•Operator signs the “Witnessed By” field on the manufacturing record for addition of an ingredient even though they were not present at that time due to multiple, competing duties. What’s the potential impact of this?

•An analyst reprints a worksheet to record new, passing data and discards the previous worksheet that contained failing data. What’s the potential impact of this?

•An old instrument has a single logon/ password. What’s the potential impact of this?

Importance/Consequences of Data Integrity? ALCOA Plus USFDA Guidelines

•If the integrity of the data generated has not been maintained, there is no confidence in the product.

•Data integrity issues could impact the quality and efficacy of our products and safety of the person at the end of the supply chain.

•Possible consequences of Data Integrity failures:

•Recalled product on the market that leads to mistrust and confusion for the person at the end of the supply chain

•Stopping manufacturing of product, that can lead to product shortage or no product in the market

•Lose the trust of Regulators who ensure our products are safe and effective

Understanding the requirements for Data Integrity

Understanding the Requirements for Data Integrity

•Now that we know what data integrity is and understand some of the risks related to data integrity, let’s review some ways we can protect data.

•We will review key data quality attributes that support data integrity for both electronic systems as well as paper records, and understand our responsibilities in regards to these attributes.

•All recorded GMP Data (electronic or paper based) should follow Good Documentation Practices.

•Good Documentation Practices are standards governing the creation, control, distribution, use, retention, and disposal of GxP documents and records.

Regulatory Authority Expectations , ALCOA Plus USFDA Guidelines

Regulators expect companies to strictly control all GxP data and can therefore demonstrate high levels of data integrity

Take away messages from warning letters:

Regulators are including Data Integrity as a kex topic within their inspection process.

Regulators expect to see data integrity controls in both laboratories and manufacturing areas.

Trends in data integrity issues across the industry has led Regulators to issue guidance on expectations. These can be easily remembered by the acronym ALCOA.

Scenario 1


While collecting samples, Ken (initials KST) mistakenly left the sample site blank. Quickly after completion of the task, Ken realized his oversight but because the batch record was now being used by other employees, he could not make an annotation.

Ken decided to note the sample site on an available piece of paper with the intention to add the missing information once the batch record became available.

During the end of shift review, Ken’s blank entry was noted by a team member and the batch record was returned to him to address the missing sample site.

  Which ALCOA attributes are missing or at risk?

•Primary Issue: Missing information/Sticky Note

◦Risk Attributable, Contemporaneous, Original, Accurate

•Secondary Issue: Inconsistent sample volume

◦Risk Accurate

 For the missing ALCOA attributes, what would be an appropriate course of action to ensure data integrity is maintained?

•It is not appropriate to record GMP data on a non-GMP source (e.g. scrap paper).

•STOP and talk to your manager and Quality about the situation.

•We must retain the original data which in this case is the scrap paper. If there is no additional evidence available, e.g. electronic record, the scrap paper should be retained with the batch document.

•Before retrospectively entering data (or asking others to do so), think through the situation and determine what supporting documentation is needed.

•Review the current process and see how the situation can be avoided in the future (e.g. not removing the batch record from the area before all data is entered).

Lesson Learnt

STOP and rapidly speak to your manager and Quality if unsure about how to

handle missing or incomplete data.         

Scenario 2

Ahmu is an experienced operator but today has been asked to help with storing bulk product, a task that he is trained on but does not perform regularly.

Ahmu completed all steps as directed in the batch record and documented all required information as he completed each step. However, it wasn’t until he had transferred the bulk material to the container that he realized a second signature for the weight was required prior to the transfer.

This weight was taken by an ‘off line’ scale so the weight was not captured anywhere else.


Which ALCOA attributes are missing or at risk?

             Primary Issue: Lack of Verification

              Risk Contemporaneous, Accurate

             Secondary Issue: Inconsistent entries

              Risk Accurate

For the missing ALCOA attributes, what would be an appropriate course of action to ensure data integrity is maintained?

•Ahmu needs to involve his supervisor immediately and discuss the situation with Quality to determine the impact of missing this verification step.

•There may be a need to raise a deviation as this could be a critical step and the procedure was not followed.

•A standard format should be in place for all data entries.

•First line leaders should evaluate the tasks required and prioritize the team’s actions based on capabilities and proficiencies.

Lesson Learnt

Review procedures and documents prior to performing an unfamiliar task to see if/when additional support is required.

Scenario 3

Alicia was asked to complete Mixing Step B that a co-worker had been working on.

Alicia reviewed the step and noted that the only action required of her was to record the mixing end time and calculate the elapsed time, ensuring it has mixed for a minimum of 15 minutes.

Alicia stops the mixing after the required 15 minutes and was about to record the stop time in the batch record when she realized the time on the wall clock and the time within the system are a couple minutes off. Alicia does not know which clock was used to capture the initial start time. Additionally, her co-worker had also already signed and dated the performed by box as she started the mixing step.

Which ALCOA attributes are missing or at risk?

             Primary Issue: Multiple time sources

              Risk Accurate

             Secondary Issue: Previous Operator already signed step

              Risk Attributable, Contemporaneous

 For the missing ALCOA attributes, what would be an appropriate course of action to ensure data integrity is maintained?

•If possible, check with the co-worker that started the mixing – confirm what clock was used. If the co-worker cannot remember, then immediately escalate the situation to the supervisor to determine what to do.

•Alicia must co-sign the “Performed By” within the batch record for the activity she performed. There are situations where multiple employees work on the same task/activity, we must have the information to identify all the employees that performed that task.

•Alicia must notify her supervisor to remove the potential of this issue happening again. Consider removing the wall clock if there’s no need for it or clarify which clock should be used in the procedure.

•Need to look at the document design to identify ownership of each task/data. For tasks that can be broken up between employees, design documents to accurately capture who started the task and who finished it.

Lesson Learnt

Minimise the sources of variability and include your name if you help perform a task.

 Scenario 4

Audrey, a lab analyst, is making a correction to a document (highlighted below) she completed during her analysis that day.       Her lab maintains all documentation electronically which requires her to scan and save the document as an attachment within the Laboratory Information Management System (LIMS).

When Audrey sits down at the lab terminal she notes that another analyst is still logged into the computer and has the program that she needs opened to make her update.

Which ALCOA attributes are missing or at risk?

             Primary: Employee not logged out of program

              Risk Attributable

             Secondary: Corrected data obscuring initial entry

              Risk Legible, Original

For the missing ALCOA attributes, what would be an appropriate course of action to ensure data integrity is maintained?

•Audrey should not perform the task under someone else’s login ID. She must either log them out or use another terminal.              If the system does not allow a user to log out someone else, contact system admin or supervisor to log the user out.

•IT may need to be involved to provide an appropriate solution (e.g. have the system automatically log out a user after a set period of idle time).

•The proper way to correct a written data entry error is to put a single line through the entry, provide an explanation, and initial and date.

•She should consult her supervisor and Quality to find out how to address the issue with the obscured data. Data must always be legible.

Lesson Learnt

Always log out when you move away from work terminals and never obscure any of the original data.

Scenario 5

Simon is assisting another employee perform a regular facility check.Per site SOP, these checks are required to be conducted in a particular order and documented using a bound facility maintenance log book.

They are running behind schedule and they decide that the checks can be done faster if they split up the tasks. As a result, several pages are removed from the log book so that they can both perform checks simultaneously.

At the end of the day, Simon looks to return his completed pages to the facilities log book, however, the other employee has already left for the day. Simon decides to secure the documents in his locker and leaves for the day.

 Which ALCOA attributes are missing or at risk?

•Primary Issue: Removed pages from bound notebook/Stored in locker

◦Risk Original

•Secondary Issue: Maintenance checks not performed in order

◦Risk Accurate

For the missing ALCOA attributes, what would be an appropriate course of action to ensure data integrity is maintained?

•A deviation may need to be raised as tasks were not completed sequentially as per required procedure.

•Notebooks are bound to ensure the integrity of the data being recorded. Never remove pages from bound notebooks.

•Putting GMP documents in private lockers or removing them from premises could result in them being lost. Without records to confirm critical steps, products could be considered by Regulators to be adulterated.

•Speak up and raise the time constraint concerns with the supervisor so that the task can be appropriately scheduled or resourced.

Lesson Learnt

Continuous improvement is good, however ensure that changes to ways of working are controlled properly and seek advice from the appropriate groups before implementing             (e.g. Quality).

Next Steps

Data Integrity Culture

There are 6 key enablers to ensuring a good Data Integrity culture is in place:

1.Blame free environment - openness and transparency

2.Simple processes and procedures that are clearly understood

3.Leaders listen and act on issues/concerns raised

4.Mistakes are seen as a learning opportunity – focus on the problem      not the person

5.Supervisors/First Line Leaders are present in the local area

6.Everyone is focussed on quality – not just supply

Take a few minutes to reflect and discuss these points. Can you answer ‘yes in place’ to each of them?

If not, talk to your leaders after this awareness session about how they can be improved in your area.


•Following the ALCOA principals is essential whether you are dealing with paper or electronic data.

•It is important to always follow procedures as it ensures the integrity of the data.

•If you perform an operation that does not allow the recording of data in real time, escalate this to your line manager.

•The impact and effort of remediating a data integrity issue afterwards is always greater than doing it right the first time or dealing with mistakes openly and honestly when they occur.

•Data integrity is important to demonstrate that products have been manufactured and tested according to approved processes. If we get it wrong, we risk losing the trust of the person at the end of the supply chain and the Regulatory Authorities.

•The person at the end of the supply chain relies on us to be responsible when handling our data

Awareness Review

1.Why is Data Integrity (DI) important?

•Regulations require our data is accurate, reliable and traceable throughout its lifecycle

•Need an approach to Data Integrity (DI) that prevents issues, ensures compliance and builds trust

2.What are 3 consequences of poor Data Integrity?

•Loss of trust from person at end of supply chain

•Recall / Stopped Production could lead to interruptions in supply

•Regulatory observations/sanctions

3.What are the Data Integrity requirements?






Key messages about ALCOA Plus USFDA Guidelines

Think about data integrity in your area of work and identify any gaps or potential risks. Discuss with your line manager how to close any gaps.

Remember the ALCOA acronym and apply the principals in your daily work.

•By keeping the ALCOA principals in the forefront of our minds when dealing with data, we can prevent data integrity issues and maintain compliance so that we can supply safe and effective products to us to person at the end of the supply chain.

•Keep in mind that there is a person at the end of the supply chain that relies on us and our data!

To Get a More detailed Idea About ALCOA you must Understand DATA Integrity and Its Effect on ALCOA , Read about DATA Integrity Here



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