Why Data Integrity is key concern for many organisations

Data Integrity is a key concern for many EAM users and features for ensuring the data integrity have been included in the core of the API PRO solution for many years. Especially the food and pharmaceutical industry has been facing increasing challenges in terms of documenting the production process closely to meet demands set forth by the Food and Drugs Administration (FDA) in the regulative, CFR 21 Part 11. 

The FDA is concerned about the validity and security of using digital processes in e.g. EAM software like API PRO as the key source of data and basis of analysis and decision-making concerning changes on equipment, maintenance procedures and production process. Furthermore, it is the view of the FDA that electronic records and signatures may easier be falsified than paper records and handwritten signatures, which is why CFR 21 Part 11 sets up strict demands which must be met to ensure that no falsification or accidental manipulation of records is done – and can be tracked and revealed in case that falsifications are made.

Compliance with the demands set forth in CFR 21 Part 11 has two aspects to it.

First of all, the system used to store and sign electronic records must meet several requirements set forth in the legislation which imposes demands on the structure, security and logging of electronic records.

Secondly, requirements which are intended to ensure the security and uniqueness of the electronic signature of any individual operating the system are imposed on the electronic signature. Both these aspects are technical requirements which the system being used in operating a plant under the rules of CFR 21 Part 11 must fulfill.

The API PRO Change Logging or Audit Trail module

The API PRO Change Logging or Audit Trail module ensures that any changes made to records are logged. In case of security of a given electronic signature being compromised for whatever reason, it is possible for the system administrator to deactivate the user account connected with the given signature. Electronic signatures in API PRO consists of a unique user name and a password. Each individual user has a unique login name, meaning that the electronic signature will be unique to one individual.

There is also a procedural component to achieving compliance. Certain standards in terms of operating procedures, user and data management must be implemented at the plant or company in question. OPTIWARE strives to assist our customers in establishing such routines through education on user and supervisor level. Click here to read more about our API PRO Academies

A validation process which addresses whether the requirements have been met – both technical and procedural – must be executed to ensure that actual compliance has been achieved. The aspects of the validation process both at OPTIWARE and at the customer site will be addressed in this paper.

It is important to note that actual compliance with CFR 21 Part 11 is the responsibility of the customer, not the supplier.

While CFR 21 Part 11 forces companies to an extent of administration which is beyond what was necessary to up-hold good manufacturing practices before, it also has benefits. The faster processing of data, better control of the plant, more extensive and available basis for analysis and the possibility to submit records to the FDA in electronic form are all things which improve the productivity of manufacturing plants.

OPTIWARE has skilled and experienced personnel, regarding FDA requirements and GAMP guidelines, and can therefore offer assistances, when performing the validation project. Several validation options can be provided, from handling the full validation project to provision of test plan templates. Get in touch with us and learn more