WHAT IS 21 CFR?
REGULATION 21 CFR PART 11
by marketing on 2 de June de 2023
The acronym CFR refers to the "Code of Federal Regulations" regulated by the FDA (US Food and Drug Administration). Food and Drug Administration). The 21 CFR is the policy that regulates manufacturing standards for the pharmaceutical, cosmetic and chemical industries, medical device manufacturers and food companies.
Part 11 specifies criteria for ensuring the reliability of electronic records.
Part 11 specifies criteria for ensuring the reliability of electronic records.
HOW DOES 21 CFR PART 11 ARISE?
Once a digital records retention policy is in place, the benefits become equal to the risk factors.
Digital records allow information to be searched quickly, retrieval of records is streamlined and errors are greatly reduced by automating the collection of data.
On the other hand, digital documents do not always measure up to the reliability and authenticity of paper records. Digital data can be easily falsifiable and/or manipulated. 21 CFR Part 11 was created to establish clear rules on how to record, validate, store and exploit digital data.
Digital records allow information to be searched quickly, retrieval of records is streamlined and errors are greatly reduced by automating the collection of data.
On the other hand, digital documents do not always measure up to the reliability and authenticity of paper records. Digital data can be easily falsifiable and/or manipulated. 21 CFR Part 11 was created to establish clear rules on how to record, validate, store and exploit digital data.
ESSENTIAL POINTS TO COMPLY WITH 21 CFR PART 11
The checks carried out on installations that must comply with this regulation are very exhaustive. The systems must be safe and traceable. The following requirements are essential for compliance.
1. Validation
Internal procedures must be validated and systems must ensure that they are accurate and reliable.
Access must be controlled and security must be protected, only authorised personnel should operate and validate records. Unauthorised access must be detected and reported immediately.
Access must be controlled and security must be protected, only authorised personnel should operate and validate records. Unauthorised access must be detected and reported immediately.
2. Audits
Companies must be able to present complete records of each stage of the products manufactured. The system must record during normal operation, dates of creation, modification or deletion of files, names and any type of data relating to the product. Traceability is one of the most important points and the maintenance of copies for possible audits is essential.
3. Electronic signature
Companies must be able to present complete records of each stage of the products manufactured. The system must record during normal operation, dates of creation, modification or deletion of files, names and any type of data relating to the product. Traceability is one of the most important points and the maintenance of copies for possible audits is essential.
4. Retention of copies
It is mandatory to produce back-up copies of the records generated. These copies must be stored for the defined retention period. The format of the copies must be secure and reliable and must allow them to be reviewed in case of consultation or inspection.
WHAT AREAS ARE COVERED BY THE 21 CFR?
The 21 CFR regulations cover a wide range of issues related to the safety and efficacy of food and drug products, including:
cGMP
Good manufacturing practice for medicinal products and medical devices.
FOOD SECURITY
Food safety requirements, including labelling, packaging and handling.
MEDICAL DEVICES
Classification of medical devices and requirements prior to marketing authorisation and approval.
MEDICAMENTS
Investigational New Drug (IND) and New Drug Application (NDA) requirements.
ESSAYS
Requirements for the design and conduct of clinical trials.
CONTROL
Post-market safety reporting requirements.
WHAT MUST COMPANIES COMPLY WITH?
To comply with the 21 CFR regulations, companies must follow the specific requirements outlined in the rule that apply to their products or processes.
Here are some general steps companies can take to ensure compliance:
Here are some general steps companies can take to ensure compliance:
1. Take into account the regulations
Companies should familiarise themselves with the specific 21 CFR regulations that apply to their products or processes. This includes understanding the requirements for manufacturing, processing, packaging, labelling and storage of their products.
2. Quality sistems
Quality systems that meet the requirements of the applicable 21 CFR regulations must be established and implemented. This includes procedures for maintaining records, conducting audits, investigating and correcting any non correct any non-compliance issues.
3. Training employees
Employees must be trained and qualified to perform their work in accordance with applicable 21 CFR regulations. This includes training on good manufacturing practices, quality control and record keeping requirements.
4. Maintain documentation
It is important to maintain accurate and complete documentation of your activities, including manufacturing processes, test results and any deviations from standard procedures.
5. Inspections
Be prepared for inspections by regulatory agencies, such as the FDA. This includes ensuring that all documentation is easily accessible and that employees can answer questions related to their work.
VARPE PRODUCTS SUPPORT COMPLIANCE WITH 21 CFR PART 11
All equipment on a manufacturing line is important for compliance with 21 CFR Part 11 regulations. Varpe's checkweighing equipment, as well as its x-ray inspection equipment, all contribute to improving compliance with these regulations.
These are some of the points to which Varpe's teams contribute:
Record keeping
Varpe's equipment has the ability to record and maintain data for the required or specified time.
Acces
Different levels of access are available to ensure different responsibilities. In addition to the ability to register a large number of different users. In this way each user can have his or her access level defined.
Security
Staff have a separate user name and password, the code combination can be set on a mandatory basis. Each user can be given, modified, and/or blocked access authorisations to the system. Manual logout is allowed, as well as an automatic logout after a period of inactivity (to be set by the administrator).
Traceability
The system records all accesses, dates or any kind of changes during the manufacturing of the product. The records are available in a text file (not editable).
Storage
Varpe equipment ensures the storage of all production and maintenance related data, creating an automatic daily backup and weekly rotation. They also have the ability to send the data to an external server for secure storage.
Audit trail
The system shall detect and record any changes to data or users, specifying their content (date, time, user, changed field, old and new data).
Electronic records
Electronic records: all records created provide the required security as the data cannot be distorted, deleted or manipulated in any way.