An essential element of effective quality management is timely access to accurate and complete quality data.
The ALCOA+ requirements set the standards for data quality, outlining the nine core elements of data integrity: Attributable, Legible, Contemporaneous, Original, Accurate (the five original ALCOA attributes) and Complete, Consistent, Enduring, and Available (the four additional attributes that comprise the “+”).
The ALCOA requirements are central to the U.S. Food and Drug Administration’s (FDA) Current Good Manufacturing Practices (CGMP). At a minimum, a life sciences manufacturer must meet these requirements to be compliant.
But it is extremely challenging for a manufacturer to meet ALCOA+ quality data standards if it is still relying on manual, paper-based quality management processes that breed inconsistency, errors and omissions.
Just think about the risks to data quality when multiple individuals are typing information into offline Excel spreadsheets and emailing these documents back and forth throughout the enterprise or drawing disparate data from disconnected systems and performing manual reconciliation and analysis in an attempt to uncover insights into quality performance.
Furthermore, the use of electronic systems isn’t enough to satisfy ALCOA+ requirements.
When a manufacturer relies on disparate, stand-alone systems that are not integrated and incapable of seamless data sharing, the resulting output of information is typically out of sync and outdated.
On the other hand, those manufacturers that have in place an electronic, enterprise-wide platform for quality management that integrates with key systems (e.g. ERP, LIMS, MES) and automates processes have the level of visibility, control and data integrity to meet or exceed ALCOA+ standards.
More importantly, with immediate access to comprehensive and accurate data, a manufacturer is able to not only maintain regulatory compliance but also identify and address issues faster to reduce costs, avoid recalls and protect patient safety.
Manufacturers with manual, paper processes MIGHT be able to comply with ALCOA+ if they spend a great deal of time, effort and resources on quality data management.
However, companies that use a centralized, cloud-based system like Sparta’s TrackWise Digital are much better positioned to achieve ALCOA+ compliance and reduce manual effort due to the nature of the system. Furthermore, they can use the data in the most efficient way to improve decision-making across their organizations.
Here are the ways that Sparta’s TrackWise Digital enterprise quality management system (EQMS) enables life sciences manufacturers to achieve this:
Because TrackWise integrates with many other systems that a quality team needs for enterprise-wide quality management (e.g. ERP, LIMS, MES), they can perform tasks in collaboration with relevant stakeholders (e.g. R&D, manufacturing, suppliers) within a single platform. This enables a manufacturer to achieve the following ALCOA+ elements:
- Original and Contemporaneous: A quality team can perform its tasks within the TrackWise Digital platform (e.g. development, approval, execution, documentation, etc.); therefore, the data is original and recorded contemporaneously (at the time the task is taking place).
- Legible, Accurate, and Attributable: With a single, electronic source of truth for quality management processes and data, where data from integrated systems flows seamlessly into the platform, there is no copying/pasting or keying in data from other sources, increasing data accuracy and ensuring legibility. Furthermore, TrackWise Digital captures the original data sources, making the information attributable to a specific system (e.g. manufacturing data from MES).
TrackWise offers a full audit trail with features that enable a manufacturer to meet multiple ALCOA+ data integrity requirements:
- Attributable: The audit trail includes user ID, old and new value, and time stamp. Whenever a new entry is made, or an existing entry is modified or deleted, TrackWise attributes the change to a user and records when and where the change was made.
- Complete and Enduring: The audit trail maintains a complete record of activity in the EQMS, including any reanalysis performed. Even when a change to a record is made, nothing is ever permanently deleted – users can access the audit trail to see a complete history of all activity.
- Contemporaneous and Consistent: Because the audit trail is always running in the background, it documents activity as it happens, ascribing a date and time stamp in chronological order.
- Available: With all information recorded and tracked within the platform, data is available for review, audit or inspection over the lifetime of the record.
Direct User Interface with Mobile Portability
As a web-based platform, multiple users, including third party suppliers, can interact with TrackWise on-site or remotely, performing tasks and sharing information for true enterprise-wide collaboration.
- Available: Quality data is always available to users through TrackWise wherever and whenever they need it.
- Attributable: TrackWise attributes actions to the particular user who performed them – from internal quality management team members to external suppliers – whether they are using the platform from their desktop or from a mobile device.
- Original and Contemporaneous: Because users can access TrackWise via mobile devices, they can record original information on tasks as they are taking place, whether that is within the four walls of the company or half way around the world.
- Accurate: Direct data input into the EQMS, anytime, anywhere, drives greater data accuracy, compared with users having to record details after the fact.
TrackWise offers reporting capabilities that enable users to track and trend quality data, identify patterns, and make decisions directly within their quality system.
- Available: With flexible reporting, TrackWise Digital users can access information relevant to their specific needs, from a high-level view of process performance to more granular on a specific corrective action, and delivered on a pre-set schedule
- Legible: TrackWise Digital enables the recording and reporting of information in human readable terms in accordance with 21 CFR Part 11 regulations.
Summary of ALCOA+ with TrackWise Digital (TWD)
In the second post of this series, we’ll examine how life sciences manufacturers are using TrackWise Digital to exceed ALCOA+ standards and leverage Industry 4.0 technologies (e.g. AI, ML, IoT) to make the fundamental shift from reactive to proactive quality management.