21 cfr part 11 compliance checklist

Thus, companies in the health sector have increasingly invested in the automation of processes and the use of electronic records to replace paper. Such change guarantees the integrity of the information generated through automation. In other words, they must always represent reality, inviolable and stored in a secure environment, in addition to being produced automatically and free from any flaws.

 

However, to validate the system, it is necessary to observe if it has some important characteristics, such as:

 

Individual access with login;

Password for time control of sessions;

Protected data;

Possibility to copy the data or print it;

Have a password recovery or change policy that allows for an audit.

These are essential items that need to be in the system. This ensures that the validation will be effective.

 

Qualification of systems

Qualification is an important pr

ocess when validating systems. It is the sum of actions created to document and attest that systems, equipment and facilities lead to the expected results. Qualification is an integral part of the validation process, but the individual steps of the qualification process do not signify the validation of a process.

 

Thus, to have a controlled process, it is necessary to validate and qualify the system. And before the validation process, the equipment must be authorized and calibrated.

 

A company's quality system, to be considered complete, must contain an equipment qualification or process validation. In this way, when a qualification is carried out well, it avoids rework and reduces deviations. At the same time, it optimizes time and allows for a continuous improvement program to be carried out.

 

First, before starting the qualification activities, it is up to the manager to assess which qualification strategy will be followed. Every 21 cfr part 11 compliance checklist company needs to define the path to follow, and this must be recorded in the validation master plan (PMV).

 

For Anvisa, the documents must follow the PMV and must be auditable. In other words, in case of an audit, these documents must be available, and they are;

 

Project Qualification (QP)

The Design Qualification protocol checks all documentation. Its objective is to analyze if the equipment meets the requirements requested to be installed and operated and if it complies with the user specifications (URS - User Requirements Specifications ). It also checks if it corresponds to the Good Manufacturing Practices standards required by the company.

 

Installation Qualification (QI)

Set of actions taken to certify and document that any facilities, systems and equipment are properly installed and/or function correctly. It also checks if they lead to the expected results. Qualification is often a part of validation, but the individual qualification steps alone do not constitute a process validation.

 

Operational Qualification (QO)

Set of operations that establish, under specified conditions, that the system or subsystem operates as expected, in all operational ranges considered. All equipment used in performing the tests must be identified and calibrated before being used.

 

Performance Qualification (QD)

Documented verification that the equipment or system presents consistent and reproducible performance, in accordance with defined parameters and specifications, for extended periods. In certain cases, the term “process validation” may also be used.

 

What is 21 CFR Part 11?

In March 1997, the US Food and Drug Administration (FDA ) issued regulations that established the criteria for accepting electronic and handwritten records and signatures executed on electronic documents. These rules also apply to pharmaceutical companies, biotechnology companies, biological product developers and other industries regulated by the FDA.

 

These laws are codified as Part 11 of Title 21 in the Code of Federal Regulations, or 21 CFR Part 11. It is divided into three subparts:

 

General Provisions

The General Provisions section discusses the scope of regulations, when and how they should be implemented, and defines some of the key terms used in the regulations.

 

electronic records

The Electronic Records section sets out the requirements for administering closed and open electronic records keeping systems. It also discusses signature manifestations and the requirements for linking signatures to registrations.

 

electronic signatures

Finally, the Electronic Signatures section is divided into three parts: general requirements for electronic signatures, electronic signature components and controls, and controls for identification codes/passwords.

 

It is also necessary to remember that electronic signatures are authentications with modern encryption systems. This ensures the identity of the person and the system has its reliability attested to in the document.

 

Since its original publication, 21 CFR Part 11 has generated a significant amount of confusion among medical device manufacturers and other industry professionals who may use electronic records. The FDA issued a guidance document in August 2003 to clarify the scope and implications of various parts of the regulations.