What is Data Integrity?

  • Data integrity is a term used in fields such as information processing, and refers to data that is complete, consistent, and accurate. In the pharmaceutical industry, data integrity is primarily used to ensure patient safety.

    Data integrity itself is by no means a new concept. It is a concept that has been required in the past under Good Manufacturing Practice (GMP) and is, so to speak, common sense.

  • What is GMP?

    GMP is an abbreviation for "Good Manufacturing Practice" and refers to "standards for manufacturing management and quality control." GMP stipulates standards for manufacturing management and quality control from the procurement of raw materials to shipping. In particular, the standards for pharmaceuticals are called "pharmaceutical GMP."

Data integrity in the pharmaceutical industry requires that data comply with the "ALCOA Principles" and "CCEA" set out by the FDA and EMA.

  • About the ALCOA Principles

    Data integrity means that data is consistent and complete throughout its lifecycle, and that there are no gaps. "ALCOA" is the requirements that must be met to prove data integrity.
    The acronym "ALCOA" is an acronym for "Attributable," "Legible," "Contemporaneous," "Original," and "Accurate," and indicates the requirements that must be met.

Background to the demand for data integrity

  • The biggest reason why the pharmaceutical industry needs to address data integrity is to protect the safety of patients, who are the users of pharmaceuticals.
    If there are inconsistencies, missing data, or even falsification in pharmaceutical records, it could pose a threat to the health and even lives of patients. For this reason, companies must strive to ensure data integrity throughout the entire process, from research and development to manufacturing and sales.

  • 01

  • Illegal manufacturing has become a major social issue

In recent years, fraud resulting from improper handling of data, such as data falsification and tampering, has become a major social issue. As a result, the importance of data integrity, which has long been essential in pharmaceutical manufacturing, is becoming more widely recognized.
Especially since 2015, regulatory authorities around the world have issued a series of guidance focused on data integrity, and there have been reports of non-compliance being found during inspections and businesses being subject to severe penalties such as the revocation of their manufacturing licenses due to fraud.

  • 02

  • Guidelines from various countries and revised GMP ordinances in Japan

As mentioned above, in response to the increasing number of data integrity issues, regulatory authorities around the world are issuing a series of guidance on data integrity.
Guidelines issued by the MHRA in 2015, PIC/S and WHO in 2016, and the FDA in 2018 have all called for the need to address data integrity.
In Japan, data integrity measures in line with international standards are now required after joining PIC/S in 2014. Furthermore, the revised GMP ministerial ordinance will come into effect in August 2021, adding new requirements for data integrity and making measures mandatory.

  • 03

  • The advancement of IoT has brought about a paradigm shift

"Pharma 4.0" is the pharmaceutical industry version of the concept of "Industry 4.0," which has brought about great advances in factory automation. Based on this concept, smart factories using IoT are being developed in the pharmaceutical manufacturing industry. As a result, the management medium for GMP records is also shifting from "paper" to "computer systems." As electronic data recording becomes more widespread, new measures such as computerized system validation (CSV) and audit trails will become necessary, and the very nature of data integrity measures will have to be reconsidered. This paradigm shift in the world has reminded us of the importance of data integrity.

Why Data Integrity Isn't Moving Forward

  • Paper documents remain between the MES and the PLC.
    The existence of unique circumstances unique to Japan

    When promoting digitalization of production sites to ensure data integrity, it is essential that information held by lower-level systems, such as PLCs (control devices), be collected in a higher-level system, a manufacturing execution system (MES), so that the higher-level system can issue appropriate instructions to the lower-level systems.
    In manufacturing sites where a software platform has not been introduced between the MES and PLC, there are still many cases where manual intervention is required, based on paper instructions and work records.
    By integrating the MES and PLC systems through digitalization, recording, operation, and approval tasks can be automated and computerized.

  • Barriers preventing centralized digital data management

    Although digitalization is a simple term, in reality, in manufacturing sites where old and new equipment are mixed, replacing existing systems is difficult, and the reality is that you honestly don't know where to start.
    In reality, replacing all equipment to comply with data integrity standards will require time, money, and specialized know-how. Furthermore, the hurdle of "Computerized System Validation (CSV)" specific to the pharmaceutical industry will no doubt be high. This is why the selection of optimal software and the support of a system integrator who can accompany you are required.

  • What is Computerized System Validation (CSV)?

    Computerized System Validation (CSV) in pharmaceutical manufacturing is a set of regulations that require the verification and documentation of the optimum and validity of the development process for computerized systems used in the development and manufacturing of drugs, quasi-drugs, cosmetics, and medical devices.
    In implementing CSV, the Ministry of Health, Labour and Welfare has established the "Guidelines for Proper Management of Computerized Systems for Drug and Quasi-drug Manufacturers and Distributors." These guidelines are consistent with CSV guidelines such as GAMP5 and PIC/S in the US and Europe, and adopt the concept of the lifecycle of a computerized system from development to verification, operation and disposal. Systems that carry out operations related to the "Ministry Ordinance on Standards for Manufacturing Management and Quality Control of Drugs and Quasi-drugs (GMP Ministerial Ordinance)" and the "Ministry Ordinance on Standards for Quality Control of Drugs, Quasi-drugs, Cosmetics, and Regenerative Medicine Products (GQP Ministerial Ordinance)" must comply with the guidelines.

Utilize the most suitable software package to address data integrity and promote digitalization

  • As mentioned above, one effective option for data integrity and digitalization of production sites is to use software packages that are familiar with the pharmaceutical industry. The most obvious way is to replace the existing touch panel with a SCADA. If a complete replacement is difficult, you can also partially modify it so that only the settings, monitoring, and recording of important GMP-related parameters are performed from the SCADA.

    This will enable operations that ensure data integrity by focusing on GMP-related parameters, and by limiting the scope of changes to the computerized system to a certain portion, the effort required for validation will be significantly reduced.

    In addition, addressing data integrity not only improves product quality but also ensures safety, which ultimately leads to a virtuous cycle in which a company's social credibility is enhanced.

    We handle Siemens' MES packages "Opcenter Execution Pharma" and "SIMATIC SCADA SYSTEM" as systems and tools that can support data integrity measures.
    We can provide a wide range of support for data integrity, from replacing production equipment and systems to making the entire factory smart. If you have any issues with data integrity, please feel free to contact us.