In a modern pharmaceutical laboratory one often feels how easy things would be if MS Excel ® offered regulatory compliance. Excel offers excellent functionality to meet most requirements, be it calculations, COA, on line data book or any other information. However lack of regulatory compliance severely limits the use of Excel. LabHawk is a unique solution which allows one to harness the power of MS Excel ® and at the same time meet regulatory compliance for electronic data including 21 CFR Part 11. LabHawk provides a security shell around MS Excel ® and generates audit trials, gives controlled access and elaborate user management. So all the flexibility of MS Excel ® is available with regulatory compliance.

The Rapid Extraction System from CambTEK, Cambridge, UK offers innovative automation in sample preparation for solid dosage forms like tablets, capsules, pellets, powders, gels, swabs, stents, beads etc. The RES uses turbulent fluidic flow and optional ultrasonic energy to extract samples. The samples are loaded in the flow cell and the system automatically performs extraction, filtration and dilution before dispensing in a HPLC vial, ready for analysis. The five solvent lines offer flexibility and mix choice of solvents. The 2 D barcode is used to track the sample right from extraction to disposal to comply with the regulatory norms. With this system one of the most cumbersome tasks of a laboratory is automated freeing the chemists for other jobs. This is apart from a host of advantages one gets from automation of sample preparation, some of which are listed below: Full traceability of samples from extraction to disposal by use of 2 D bar codes, compliant with latest requirements. Unattended operation of up to 30 samples. Fluidics and sonication provides equivalence to manual methods Comprehensive post extraction report allows for detailed OOS investigations. Eliminates manual variations to ensure consistent results irrespective of user or laboratory. Cleaner and safer environment as closed system results minimal solvent vapours. Easy to use and user friendly software.

One of the weakest links in regulatory compliance in a pharmaceutical laboratory has been handling the weighing done routinely. LWMS offers on line capture of weighing from analytical and other balances and record them in a data base. The weights can be assigned to particular samples or AR Nos and can be easily traced through LWMS. Weights of not only sample and standards but also those required for mobile phase preparation or any other purpose are captured and categorized accordingly. Provision for tracing for particular AR No or sample greatly eases review which can now be done on line. Weight printouts can be done away with. Some key features are : Online capture of weights and recording in Data Base for all types of weighing. On line review by filtering on AR No, sample name or any other keyword possible. Automatic transfer of weights to Chromeleon CDS. Extensive reports include balance log, user wise logs and many more. Flexible User Management and policies allows to configure the software to individual needs.   LWMS is a great step towards enhancing data integrity and achieving regulatory compliance.

In a modern pharmaceutical laboratory one often feels how easy things would be if MS Excel ® offered regulatory compliance. Excel offers excellent functionality to meet most requirements, be it calculations, COA, on line data book or any other information. However lack of regulatory compliance severely limits the use of Excel. LabHawk is a unique solution which allows one to harness the power of MS Excel ® and at the same time meet regulatory compliance for electronic data including 21 CFR Part 11. LabHawk provides a security shell around MS Excel ® and generates audit trials, gives controlled access and elaborate user management. So all the flexibility of MS Excel ® is available with regulatory compliance.

The Rapid Extraction System from CambTEK, Cambridge, UK offers innovative automation in sample preparation for solid dosage forms like tablets, capsules, pellets, powders, gels, swabs, stents, beads etc. The RES uses turbulent fluidic flow and optional ultrasonic energy to extract samples. The samples are loaded in the flow cell and the system automatically performs extraction, filtration and dilution before dispensing in a HPLC vial, ready for analysis. The five solvent lines offer flexibility and mix choice of solvents. The 2 D barcode is used to track the sample right from extraction to disposal to comply with the regulatory norms. With this system one of the most cumbersome tasks of a laboratory is automated freeing the chemists for other jobs. This is apart from a host of advantages one gets from automation of sample preparation, some of which are listed below: Full traceability of samples from extraction to disposal by use of 2 D bar codes, compliant with latest requirements. Unattended operation of up to 30 samples. Fluidics and sonication provides equivalence to manual methods Comprehensive post extraction report allows for detailed OOS investigations. Eliminates manual variations to ensure consistent results irrespective of user or laboratory. Cleaner and safer environment as closed system results minimal solvent vapours. Easy to use and user friendly software.

One of the weakest links in regulatory compliance in a pharmaceutical laboratory has been handling the weighing done routinely. LWMS offers on line capture of weighing from analytical and other balances and record them in a data base. The weights can be assigned to particular samples or AR Nos and can be easily traced through LWMS. Weights of not only sample and standards but also those required for mobile phase preparation or any other purpose are captured and categorized accordingly. Provision for tracing for particular AR No or sample greatly eases review which can now be done on line. Weight printouts can be done away with. Some key features are : Online capture of weights and recording in Data Base for all types of weighing. On line review by filtering on AR No, sample name or any other keyword possible. Automatic transfer of weights to Chromeleon CDS. Extensive reports include balance log, user wise logs and many more. Flexible User Management and policies allows to configure the software to individual needs.   LWMS is a great step towards enhancing data integrity and achieving regulatory compliance.