Implementing 100% Paperless Lab
About the Company
A leading South African pharmaceutical manufacturer, listed on the Johannesburg Stock Exchange.The Company manufactures, markets and distributes a wide range of healthcare products. The company is a leading supplier to both the private and public sectors of the market. Expansion into emerging markets has given the company a presence in sub-Saharan Africa and India.The company has invested in a manufacturing facility in Bangalore, India, which offers an alternative source of supply for the South African market. The company has more recently invested in a marketing operation based in Mumbai which has a nationwide coverage.
Objective of Paperless lab
- To improve workflow efficiencies by eliminating manual data entry where the data is transferred from system to system via manual input, using paper which is a slow and inefficient process and to eliminate the transcription errors.
- To redesign the current process and optimize it by removing the bottlenecks and issues with electronic ways of working which will have stringent controls, checks & balances through automation to meet the international quality regulations like GLP, GMP, 21CFR Part 11 and 17025.
- To design the LIMS environment integrating with all the other systems and instruments to create a 100% paperless lab.
- In the lab, data is captured in various stages of sample testing, the following are the few important stages.
- All test results performed by the analyst as per the specification.It has instruments of the like HPLC, UPLC connected to the network and PH meters, balances which are used during analysis of various samples. These instruments give results for tests performed, which are further used in the sample testing.
- The information like product code, batch number, batch size, sample quantity which are maintained ERP are used to generate a lot for sample testing before it is released for further activity. Once the COA for the sample is released, the usage decision is entered into the ERP system which will help in releasing or holding of the material for further production process.
- The review and approve names need captured in every stage of the sample testing from Specification to COA release.
- Deviations of the results during the sample testing need to be recorded and a CAPA need to be documented. All the audit observations need to be captured with action points.
- The specification documents, SOPs, methods, test techniqes need to be readily available when ever needed during the test analysis.
The following are the objectives laid out to implement a LIMS application
- Adhering to Compliance to regulations like GLP, GMP, 17025.
- Data Access and Security norms as per 21CFR Part 11
- Seamless Integration of 25 instruments in the lab with all desired regulatory checks
- Integration with ERP
- Integration with Quality Management systems and DMS.
- 100% Paperless Laboratory
Building a paperless lab
A Scalable, Hosted and Integrated solution – CaliberLIMS was suggested which will provide a holistic solution ensuring high data integrity and data security. This solution will adhere to Compliance to regulations like GLP, GMP, 17025 and Data Access and Security norms as per 21CFR Part 11.
Critical processes automated:
- Intimation for sampling of material from stores and production. Under test label printing.
- Sample Login through ERP with complete automation and controls.
- Sample registration and Sampling procedure of various Material inspections from various sources like Stores Production and warehouse.
- Assignment of tests concerned test categories like: Chemical Analysis, Physical analysis, Microbiological analysis etc.
- Protocol preparation and results evaluation and recording through Electronic worksheets.
Advanced seamless Bidirectional integration with CDS (chromatography Data Server) First of its kind in India.
- Inventory and Usage of Chemicals, Reference standards, Working standards, and also Instruments. Usage recording through integrated electronic worksheets.
- Results approval and certificate generation. On-line review process by multiple levels of supervisors.
- Material Usage decision and intimation to stores and Production.
- Approved label printing on the containers
- OOT and OOS trends
- Stage testing
Automation of these processes has saved enormous time and efforts. CaliberLIMS has helped the company to improve the through put, regulatory compliance, reduction of errors and obtaining quick reports for a timely decision and completion of the quality product manufacturing on time and now has the distinction of 100% paperless laboratory.
CaliberLIMS Implemented in one plant at Bangalore. After completion of the project, the company has been successfully audited by international regulatory bodies, with appreciation for the automation.
The company achieved zero deviations through the controls and automation.
- On Average 2000 samples /month have been released from Caliber LIMS.
- On a scale of 1 to 10. (1 as low and 10 as high) he has rated following parameters as follows.
- Errors are reduced. (7)
- Quality Performance is increased. (7)
- Planning of the team is improved. (7)
- Impressed with Sample Manager and Stability Management modules.