Electronic records and electronic signatures are important concepts in the pharmaceutical industry. Electronic records refer to any information that is created, stored, or processed electronically, such as documents, spreadsheets, and databases. Electronic signatures, on the other hand, are digital signatures that are used to sign electronic records.
In simple terms, electronic records are like digital files that contain important information for the pharmaceutical industry, while electronic signatures are like digital signatures used to confirm the authenticity and integrity of these digital files. They are both important tools for ensuring the accuracy and safety of pharmaceutical products.
The pharmaceutical industry is one of the most heavily regulated industries in the world. In order to ensure the safety and efficacy of pharmaceutical products, companies must maintain detailed records of their operations, from research and development to manufacturing and distribution. In recent years, the industry has increasingly turned to electronic record-keeping and electronic signatures as a way to improve efficiency, accuracy, and security.
However, electronic records are only as reliable as the systems used to create and store them. That's where electronic signatures come in. An electronic signature is a digital signature that is used to confirm the authenticity and integrity of electronic records. Electronic signatures can help to ensure that electronic records have not been tampered with and that they are legally binding and enforceable.
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In order to use electronic signatures in the pharmaceutical industry, companies must comply with strict regulatory requirements.
Handwritten signature:
An individual's penned name or legal mark is distinctively theirs and is used to verify the authenticity of the writing.
Digital signature:
you can confirm the integrity of the document you signed as well as the identity of the signer and the validity of your signature.
Electronic Record:
Data that has been created or utilized in some other way by a computer system.
Electronic Signature:
A collection of symbols used to sign documents in a computer system that is just as distinctive and legally binding as a handwritten signature. When an electronic document is signed, the information below must be accessible and connected to the signature:
- The printed name of the signer;
- Date and time of signature;
- Meaning of signature (such as that the content is accurate, the format is appropriate, or that the data calculations were confirmed). Each individual must possess a distinct electronic signature, and their identification must be confirmed.
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Password:
The following security measures must be in place for electronic signatures that use identification codes (such as user IDs) and passcodes/passwords:
- User ID and password combinations must differ for each user; they cannot be shared.
- No two users can have the same combination of the user ID and password – each variety must be unique
- Passwords must be checked, recalled, or changed from time to time
- Unauthorized attempts to access user IDs or
- passwords/passcodes must be detected and reported
Open System:
A computer system where user access is NOT controlled by the same people responsible for its contents.
Closed System:
A computer system whose user access is controlled by the same people responsible for its contents.
Validation:
Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
Biometrics:
Biometrics are means of identifying a person based on physical characteristics or repeatable actions. Some examples of biometrics include identifying a user based on a physical signature, fingerprints, etc.
Data Backup
- Data backup is the process of routinely saving computer system data to a secondary place.
- The FDA defines backup as a genuine copy of the original data that is kept securely throughout the records retention period. The backup file must contain the data (including any associated metadata) and be in the original format or a format compatible with the original format.
- This is not to be confused with backup copies, which may be made during normal computer operation and kept briefly for disaster recovery (in the event of a computer breakdown or other disruption). Such temporary backup copies would not meet the obligation to keep a data backup file.
Data Recovery:
Data Recovery is the process of restoring a file from this backup file location to general use.
Data Archiving:
Data Archiving is the process of removing older or less utilized data from a computer system in order to improve system performance.
Disaster Recovery:
Disaster Recovery is the process of recreating a computer system in the event of a serious system failure.
Rendering Records:
How an organization makes sure that all electronic records that an auditor might want to see and/or a copy can be provided in a language/format that humans (not just computers) can understand
Document Storage & Record Retention:
How an organization protects documentation and keeps it readily available for as long as it’s required to be stored.
System Access:
How an organization ensures that only the right people have access to each computer system.
Audit Trails:
How an organization ensures that a complete history of an electronic record is automatically captured by a computer system, retained in the system for the right amount of time, and viewable by humans.
Device Checks:
How an organization verifies that equipment being used for regulated purposes is functioning properly
Personnel Qualifications:
How an organization makes sure only trained and qualified people perform functions on or within the system.
Document Control:
How an organization controls documents related to system operation and maintenance and preserves the complete history of changes made to these documents
Legacy system:
The legacy system is an old method, technology, computer system, or application program relating to a previous or outdated computer system. This can also imply that the system is out of date or in need of replacement.
Copies of Record:
- You should provide an investigator with reasonable and useful access to records during an inspection.
- We recommend that you supply copies of electronic records by:
- Producing copies of records held in standard portable formats when records are maintained in these formats, Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML)
- Generating copies of records and any corresponding requirement
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Quality Assurance
