Vaccine production underlies strict pharma regulations related to data integrity, full traceability, and compliance, including 21 CFR Part 11 and ALCOA+. A core aspect of these regulations is organizing, managing, and reviewing relevant data from all the quality control checks that have to be performed, not only on the final products, but on all excipients and APIs used to formulate the products. AP Connect, our lab execution software, is helpful here. It connects your laboratory instruments to data management systems, giving you digital and error-free data flow. What’s more, it comes with a Pharma Edition with crucial features – like electronic signature and electronic audit trails – that fulfill all of your specific pharma industry requirements.
Explore our solutions for data integrity in more detail below.
In order to ensure safety and consistency, vaccine manufacturing sites are required to perform many quality control tests, not only on the final products, but on all excipients and APIs used to formulate the products.
Good data management practices influence the quality of all data generated and recorded by a manufacturing site. These practices, also known as the ALCOA+ principles for data integrity, should ensure that all data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available throughout the lifetime of the drug.
Anton Paar instruments used for quality control and characterization of the physical properties of excipients, APIs, and final formulations deliver data to the AP Connect software as part of fulfilling the ALCOA+ principles for data integrity.
The AP Connect software ensures data quality according to the ALCOA+ principles for data integrity by:
Instruments:
Webinar:
Paperless lab processes with digital records require tailored submission, review, and approval processes for a complete chain of responsibility.
To have them comply with the ALCOA+ principles for data integrity, most companies need electronic signatures on all pertinent electronic documents and data-sets.
The process of implementing and controlling such electronic signatures can be extremely complex, and regulatory agencies such as the FDA expect that electronic signatures are the equivalent of handwritten signatures, initials, and other general signings required by standard operating procedures.
Anton Paar instruments are equipped with electronic signature features on the instruments, which enables users to put a verified signature on data items that are “reviewed” or even “approved” after initial submission.
A combination and integration of an instrument with Anton Paar Connect Pharma allows for a well-tailored signature process and safe data storage in a centrally available SQL database.
The use of electronic signatures ensures that all electronic records will be traceable and equivalent to handwritten signatures – this way establishing a chain of responsibility.
The combination of an instrument and AP Connect Pharma lets you customize the review and approval actions according to your specific SOP.
These actions, just like later search and filter tasks, can even be managed remotely without the instrument present once the data has been exported to AP Connect. This provides insight into all data for audit purposes.
Instruments:
Webinar:
According to the FDA guidelines for data integrity, an audit trail is a chronology of the “who, what, when, and why” of a record. Audit trails are used to prevent data from being lost, changed, or obscured. This is especially important for complex pharmaceutical products like vaccines, which involve numerous steps in production – sometimes even distributed around several manufacturing sites or laboratories.
Creating, maintaining, and reviewing a system for compliant audit trails is a complex task, especially when using manual data integrity systems. A thorough check of the audit trail is a key part of any internal and external audit. Gaps here often indicate disregard and carelessness regarding well-defined production and check processes in manufacturing. Simple availability and searchability of the data are crucial.
Many Anton Paar instruments are equipped with an automatic and compliant audit trail log system that can be automatically exported to an SQL database using the AP Connect software Pharma edition.
Electronic audit trails automatically track the creation, modification, or deletion of data as well as actions at the record or system level that are then automatically generated and transferred to an SQL database for future review and additional comments, when necessary.
Anton Paar Connect Pharma ensures that all data is available all the time – if needed, even remotely. Advanced filter and search functions give a quick overview of data and actions connected to factors like instruments, users, measurement date and time, sample IDs, or methods.