Sushil Bapat, Vice President – International Business, Labindia Analytical Instruments, gives an insight on effective CFR which ensures that companies and organisations implement good business practices
Computerised systems are widely used in the pharmaceutical industry for early development, clinical trials and manufactures. An effective CFR ensures that companies and organisations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and allows any handwritten signature to be replaced by an electronic one.
21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) guidelines on using electronic records and electronic signatures (ERES). The scope of 21 CFR Part 11 includes operational areas of pharma, biotechnology or medical devices company such as: — manufacturing, maintenance and laboratory. Leading pharma, drug discovery and development companies are aggressively investing in quality management systems through initiatives that assurance compliance with company and regulatory procedures and guidelines provide release and approval of all cGMP documentation, including Standard Operating Procedures (SOPs).
Labindia complies with CFR requirement in provision of 7’’ touch screen high resolution display with user interface and interactive software for ease of operation, LAN (Ethernet) connectivity facilitates data backup on network shared folder (optional), audit trail for all activities with search facility, report generation and printing, unlimited user ID’s with alphanumeric entries of user name, password and role-based privileges selection. Multi-level roles with password protection – admin, manager, supervisor and user, user authentication is performed for each and every operation done by user, PDF report file, electronic instrument log book eliminates the paper-based equipment and facilitate logbook, USB printing eliminates the need of serial port to connect with instruments. The user can take printout on any local or network printer as well, electronic signature functionality, manual archive and restore facility and usb backup available.
21 CFR Part 11 states that records must be checked for accuracy dated and signed. These were seen as regulatory blocks on the pharma road to the digital world. Moving to fully electronic data handling promised huge cost savings from improved efficiency and reduced physical handling and storage compared to traditional paper records, as well as increased security, traceability and transferability of data. It is not just in the manufacturing (GMP) area that electronic data handling offers noteworthy benefits. The amount of data generated in analytical laboratories operation under GLP is significant, and since this data requires review and approval signatures, 21 CFR Part 11 promises major improvements in workflows and data handling.
Labindia Analytical Instruments
H.O.: 201, Nand Chambers,
LBS Marg, Thane (West) – 400 602.
Tel: +91- 22- 2598 6000/ 2598 6110
E-mail: [email protected]