Features & Benefits of Maintaining Laboratory e- records

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High laboratory throughputs coupled with efficient and secure exchange of data ensure a competitive edge for the leading laboratories.

What are Electronic records?

US FDA defines electronic records as any combination of text, graphics, data, audio, pictorial or any other information in digital form that is created, modified, maintained, archived, retrieved or distributed by a computer system

Benefits of maintaining e-records

e – records provide distinct benefits and time saving in data storage and transmission while overcoming human errors at every stage and under required security. The benefits can be outlined as :

• Improvement of efficiency of operations and ease of access to information
• Paperless workplace environment
• Additional protection of data in the form soft copies
• Saving on storage space requirements for documents
• Faster data analysis facilitates timely corrective and preventive action
• Multi-user access of data and multitasking benefits

Electronic signatures

An electronic signature is computer compilation of data of any symbol or series of symbols executed, adopted or authorized by an individual to be legally binding equivalent to the individual’s handwritten signature. It includes user IDs, passwords or cryptographically-based digital signatures.

• Signed electronic records authenticate the printed name of the signatory
• Safeguards ensure freedom from tampering
• Identification codes and passwords employed to secure integrity and security of passwords
• Audit trails lead to the signing person’s identification

Closed systems

Access is controlled by persons who were responsible for the content of the electronic record,i.e, authenticity, integrity, confidentiality and non-repudiation. Such access is contained within an organization’s local area network. A person whose electronic signature appears cannot absolve himself of responsibility of the record

Open systems

Access is universal as in case of Internet. Such documents should ensure authenticity, integrity, confidentiality and non-repudiation from point of creation to point of access. Additional measures should be taken such as encryption and digital signatures.

Benefits of data backup

There is always a lurking fear of data loss so data backup gives secure access to large volumes of data at the click of a mouse. It is a good practice to create backups daily

• All data should be backed up daily and transferred to a secure distant location to prevent accidental loss
• Irretrievable loss due to system failure can be prevented by a backup procedure
• Worksheets can be saved for a specified time to enable the construction of stored data
• Backups can be conveniently made on CDs

Guidelines for software upgradation

Advances in technology necessitate upgradation of softwares from time to time

Upgradation on computers which are integral part of instruments

• Software changes and upgrading must be recorded and validated before putting to routine use
• Software upgrades if installed by supplier should be entered in instrument maintenance record
• At time of repair service engineers should not be allowed to load any software modifications which are not authorized by laboratory management

Upgradation on computer systems managed by external agencies

• Software changes should be upgraded only against request made by authorized laboratory personnel
• Software updates under direct control of outside agency servers should be brought to the knowledge of laboratory management
• Laboratory management should authenticate such changes before these are implemented
• Outside agency should provide access to previous versions for validating earlier data if and when required

Electronic data security

Authentication, access control and auditing constitute the three supporting pillars for data security.

Authentication

• Authentication verifies the identity of users before they can gain access to data and perform transactions on electronic records through user id’s or biometric records
• Any new software should be authenticated before use in the laboratory
• Laboratory analysts should get their spreadsheets for calculation and data processing authorized by laboratory management before use.
• Spread sheets should be secured by authorized alterations through use of passwords
• All alterations should be traceable to the person making such changes and original values should be accessible

Access control

• Multilevel access is available to users
• Limited access at URL level to protect web-based resources such as domains, directories, departments, servers, etc
• Medium grained access to values associated with fields, application records, specific files, objects on we pages, etc
• Fine-grained authorization to access changes in organization policies and decisions
• Auditing traceability to user and not just the device
• Procedures to be adopted in event of alarm messages
• Alerts on failed login attempts while in progress
• Security on preservation of user locks to prevent fraudulent misuse
• End to end audit trails of all user activities

Introduction of advanced automated analysis techniques and e-maintenance of e-records can improve efficiency of laboratory operations and pave the way to your laboratory’s unstoppable growth.