Logilab SDMS supports easy readability of data in PDF format and printing. Human Readable data is also a mandatory process as per 21 CFR Part 11.

Whenever there is a report generated by an instrument software, users can store this report in a human readable format.  Logilab SDMS provides a virtual PDF printer. Once the users have finalised the data inside the instrument software, Logilab virtual PDF printer can be used to generate a human readable PDF format of the report and then send to printer for printing on a paper if required.

• Fully automated secure file handling by SDMS scheduler
• Version control and version history maintenance of files
• Human readable data for 21 CFR Part 11 compliance by PDF export and print functionality
• Better organization and categorization of data by tagging
• Better data security and control of operations by user and password management
• Controlled collaboration by sharing data with authorised group of users
• Better tracking and easy trouble shooting by Audit Train
• Complete access control of all applications including non-compliant by CFR gateway extension
• Electronic data and electronic signature which are critical for 21 CFR part 11 compliance
• Central secured data base and file server
• Contemporaneous data capture

100% Data integrity can be ensured by implementing CFR Gateway solution which compliments Logilab SDMS in many ways particularly for non-compliant and non-standard systems and applications. Upon operating system boot, CFR gateway will be the first system that is loaded at startup. In this case, users need to necessarily login to gateway in order to access any other authorised applications. Any data created, modified or deleted by the user is fully tracked and sent to the server repository automatically. Even popular applications like word, excel, pdf, etc. can be used with high level of data integrity and version control.

The data files captured are stored as flat files in a secure FTP file server as an encrypted file name. Data access and viewing is controlled through user rights providing data security. The meta-data like data source, date/time, file size, checksum and user entered tags along with parsed and extracted data is stored in the database.

Full text indexing allows strong search facility ensures availability of required data instantaneously. Built-in integration tools allow you to integrate external systems as well.

Logilab SDMS ensures that users can verify the data that is captured from the instruments can go through a workflow process. Using the workflow tool users will be guided to follow the review and approval processes so that data errors can be avoided. 

Authorised users can place electronic signatures on appropriate records with the username, password and the reason with a date and time stamp is recorded. This will ensure that users can be fixed with the responsibility to carry out necessary checks during the data transaction process.

Scheduling certain type of files generated in Lab process using file type watcher. This will ensure filtering out of unwanted data or files.

Users can identify or provide additional metadata for instrument generated data by entering batch numbers, sample types, projects, sample ids.  This improves the accuracy of the data. The instrument data can be searched easily using the specific tag name.