Data integrity is mandatory for the regulated healthcare industry. A significant increase in the number and types of data integrity issues that have been cited in regulatory inspections by both US FDA and MHRA investigators.
Drug makers must need to ensure the data integrity intact. Being pharma focused automation solution provider we offer pharma business Process automation solutions helps in addressing the serious data integrity Issues by offering 21 CFR part 11 compliance software that manages the data records accurate, complete, intact, and maintained within their original context.
A strong focus in Pharma domain made us to build 14 ready to use apps to cater the need of QC, QA and Production Areas. Our 21 CFR Part 11 compliance solutions is in use at 8 FDA approved and 2 WHO approved Units.
AmpleLogic Pharma automation solutions ensures that adequate controls to prevent unrecorded data changes. To name few
- Biometric based authentication helps in avoiding common Login Information Used by multiple individuals.
- Workflow based Print control option with AD Integration helps in avoiding printing or recording critical information on personal computers
- Pharma QMS Software ensures the data integrity compliance in the pharmaceutical industry
- Batch Record Issuance software ensures the data integrity compliance in the Batch # generation, Batch Master copy issuance and control, Batch document Ratifications
Our solutions implemented at US FDA, MHRA and WHO approved Manufacturers in the following Lifesciences Segments
- API (active pharmaceutical ingredients) and formulations manufacturers.
- Advance Intermediates and Fine Chemicals Manufacturers
- Biotechnology and R&D
- Biosimilars manufacturers
- CRAMS (contract research and manufacturing services) Companies
- Small Volume Parenteral (SVPs)
- Medical device Manufacturers