40 Years of Data Integrity & Audit Trails
The pharmaceutical industry is an industry built inherently on distrust.
The regulators distrust the manufacturers, the manufacturers distrust the employees. Employees distrust every other actor in the supply chain. And for good reason - to ensure the safety of vulnerable patients where a single slight misstep anywhere in the myriad of complex supply chains can result in life-changing consequences or even death
Therefore all pharmaceutical manufacturers must comply with good manufacturing practices while ensuring data integrity. Data integrity enables good decision-making by pharmaceutical manufacturers and regulatory authorities.
These rules and regulations laid down by the regulatory bodies dictating data integrity can be summed up by the ALCOA principle.
Data supporting the quality and safety of products must meet the ALCOA elements in order to avoid regulatory citations for data integrity issues
Attributable - The data generated or collected must be traceable back to the individual who generated the information.
Legible: The data recorded must be readable and permanent
Contemporaneous: The results, measurements, etc. must be recorded at the time the work is performed.
Original: Original or source data are the record
Accurate: The data recorded must be complete, consistent, truthful, and representative of facts.
Many of Many of the concepts for ALCOA have been captured in the regulations as far back as 1978.
The Alcoa plus principles now also state
Enduring: The data or information must be maintained, intact, and accessible throughout their defined retention period.
Available: The data or information must be able to be accessed at any time during the defined retention period.
Let’s compare ALCOA against blockchain - stored data is immutable permanent, it cannot be modified or deleted - It is almost if blockchain technology had been developed to meet the main data integrity requirements, according to the FDA's ALCOA concept.
Adapting to the growing use of computer systems in pharmaceutical manufacturing, FDA issued a guide, especially for the inspection of computer systems in pharmaceutical industries. The guide was first published in 1983 - that's almost 40 years ago.
Long before the enhanced audit trail features of blockchain were understood, these corresponding rules and regulations set out by these agencies result in layers of beau acracy.
Checking and rechecking of work due to fears over the accuracy and validity of the checks completed by third parties by external actors in the supply chain are commonplace. Data recorded by third parties is often dismissed due to this lack of trust
A common phrase throughout the industry is "We cant stand over that data"
But what if we could stand over that data?
Another regulatory requirement this time dictated by Annex 11 of the EU GMP Guidelines: 9 Audit Trails: ".
Each piece of equipment that generates data that is used in production or to make a decision relating to drug quality must provide a fully validated audit trail. A rough guess of 400 - 500 pieces of equipment all made by different manufacturers. All generating disparate audit trails that by law must be regularly reviewed. It’s another hair-pulling inefficient task.
Not having sufficient audit trails in place for the process has been the source of many product recalls
What if we could combine these disparate audit trails into a robust system that followed the ALCOA principles?
ServBlock allows for Data security, traceability, and trust between counterparties that current industrial complexes lack.
Reduce compliance risks and decrease disposition times through full and seamless integration with existing production, supply chain and laboratory systems. ServBlock presents the data to the sponsor company within the context of a role-based dashboard that can be configured to suit the needs of various manufacturing roles.