The main focus of any IT company providing software solution to pharma segment is to deliver solutions that align with cGMP compliance requirements, a mandatory obligation of this sector to regulatory agencies. On this front, BatchMaster solution which also serves the pharmaceutical segment, was tested by a well-known third-party neutral organization ‘OnShore Technology Group’ against USFDA guidelines. OnShore Technology validated BatchMaster Manufacturing for SAP Business One at many of its pharma customers-sites. This validation will give a big boost to BatchMaster’s marketing efforts and will be instrumental in providing confidence to the new BatchMaster’s pharmaceutical customers. Now, these customers wishing to go for validation will need much less documentation for the same.
‘OnShore Technology Group’ – a new word in your dictionary? If yes, then here is a quick spotlight on it-
Onshore Technology is one of the leading provider of Enterprise Validation Management (EVM) solutions and services, to deliver Independent Validation & Verification (IV&V) services globally. It has a vast target market that covers industries like Biotech, Pharmaceutical, Chemical, Medical Devices, Nutraceuticals, Healthcare and Food & Beverages. It says, “If it’s not documented, it didn’t happen”. And, thus performs intensive testing of ERP’s various modules on the parameters of Good Manufacturing Practices.
Quick glimpse of how BatchMaster solution was validated-
OnShore Technology examined BatchMaster’s pharmaceutical-specific ERP product, BatchMaster Manufacturing for SAP Business One (BMM SAP B1), not only methodically but comprehensively at five independent pharmaceutical customer sites. They keenly inspected every aspect of an organization like raw data, documentation, protocols, final reports, QA inspection, job description, past records, samples, instrument calibration and inspection records.
Post examining, the OnShore Technology was fully satisfied with the performance of the product and certified it as a complete solution meeting FDA and cGMP requirements. Moreover, this enlightened BatchMaster’s aura with the eminent partnership with OnShore Technology.
What is BatchMaster Manufacturing for SAP Business One?
BatchMaster Manufacturing for SAP Business One is a complete, out-of-the-box Pharmaceutical-Specific ERP solution built on the strong foundation of SAP Business One. It can efficiently handle the needs of pharmaceutical manufacturers like bulk drugs, APIs, private label products, contract manufacturing, or consignment based manufacturing, etc. The product follows simple and cost-efficient process model and helps manufacturers to be in compliance with cGMP requirements. Moreover, every data change is documented to prevent data deletion by verifying e-signatures manifestation and cross-examining their authenticity and uniqueness.
For more details on this product visit: BatchMaster ERP For Pharmaceutical Industries