ERP for Pharmaceutical

The pharmaceutical manufacturing industry is a highly regulated industry with a lot of radical
changes happening in the recent past. To keep up with the constantly changing market trends,
changes in the healthcare sector, frightening global competition, Pharmaceutical companies need to
adapt faster and, at the same time ensure that the changes are complied and followed.

This is best done by the use of technology and systems. There are some specific​ ERP solution for
pharmaceutical industry​ which can help Pharma companies embrace these changes.

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Designed for Batch Manufacturing

The ​ERP system should be designed for the batch manufacturing and pharmaceutical industry and
not “customised” for it as there are a lot of inherent structural needs of a batch manufacturing that
cannot be addressed by a customisation , add-on or retrofitting an existing ​ERP solution​. ERP for
pharma companies are most suitable.

Quality Control & Traceability

Quality Control is the most important point for successful and effective ERP system. QC and QA in
Pharmaceutical ERP cannot be a separate “module” but tightly integrated with all processes of the
Supply chain and Manufacturing. In the Pharma industry the QC and QA should be omnipresent
across the entire ERP Pharmaceutical process.

Regulatory Compliance

Almost all of the facts that have to be recorded and accounted for in regulatory compliance can be
maintained in ERP system and its database(s). Financial accounting transactions are obvious, but
ERP extends the capabilities to traceability of products through their manufacturing and distribution
cycle.

The ERP software should be able to pass any system validation and for organisation catering to the
US FDA , it should have the capabilities to clear a USFDA 21 CFR part 11 validation.

Audit Trails

When and how was the data recorded, who approved it and when, did anyone change it. Granular
audit trails are mandatory for any system used in a highly regulated industry like pharma, healthcare
and food.

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Data security

Data is an important asset to any organization. The pharma manufacturing ​ERP software boasts an
array of security features such as access controls, data encryption, audit trails, electronic signatures
and passwords, among others.

Production as per cGMP norms

Your ERP solution should help you to achieve a compliance by aiding your manufacturing process
and ensuring the record maintenance are as per defined cGMP guidelines.

Online availability of data

Online availability of consolidated data is a big advantage when it comes to planning the sales
strategy and getting instant MIS for other business decisions. This is relevant to any company using
an ERP.

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© Proteus Technologies Pvt Ltd. www.proteustech.in