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Top Six Reasons Why Compliance Management Is Essential In The Pharmaceutical Industry


With the unstoppable expansion of the Pharmaceutical industry, the need of a strong compliance management becomes all the more indispensable. Adhering to the regulatory compliances in every process of a pharmaceutical company, from start to finish is a long and exhaustive process. Not only the process is time-consuming, but it is expensive too. The costs incurred in obtaining FDA approvals and the expenditure in producing consistent high-quality products is significantly large. In order to overcome such drawbacks and keep pace with the increasingly pushing demand, one needs to deploy compliance management software in their respective pharmaceutical companies.

One reliable and end to end complete solution that can reduce compliance complexities is Enterprise Resource Planning (ERP) software. The effective and efficient compliance capabilities of an ERP aid in crisis management and targets broader risk management programs. With it, the companies are able to look holistically across the strategic, operational and other production activities. It not only optimizes the decision making, but also mitigate risks. When the compliance is met within the entire supply-chain, the result is greater focus on operational flow and impactful marketing activities to boost sales.



1. Facilitates Detailed Documentation
Extensive, detailed documentation is essential to the pharmaceutical industry. These details help to establish the transparency and resolve issues quickly. Documentation includes information about the regulations that companies must comply with, the details of systems installed, vendor’s details, QC specifications, reports, and inventory movement. ERP is capable of generating this all alone in a systematic manner along with printing Batch Manufacturing Records, where-used reports and product labels.

2. Raises Quality Standards
The need for quality maintenance is critical in a compliance-regulated environment for pharmaceutical companies. ERP provides a comprehensive framework for managing product innovation with solid product data management, along with quality process controls. It helps to prevent errors or failures before they occur by detecting them at an early stage. Non Conformance and Corrective and Preventive Actions (CAPA) are conducted in case of a failed QC test, which reduces the chances of recall or reworking a batch. The feature of Adverse Event reporting can be used during Audits and as a reference in the future. As quality issues are caught and addressed more quickly, the saved time and efforts obviously contributes towards the company’s bottom line. Moreover, the execution of QC becomes a cake walk with convenient sampling plans and stability testing. Batch monitoring activities and periodic Inspection plan under electronic execution eliminates chances of rework and rejections.

3. Offers Unmatched Traceability
Having in place a clear, effective and broadly communicated compliance program helps you signal the auditors that compliance is the top priority for your company. It shows your commitment to doing business the right way, to the highest ethical standards. When you are able to track and trace your products bi-directionally, the recall becomes easier than ever and the capability to take action faster. By demonstrating your expertise in the field of all the relevant laws and regulations, your brand name creates a powerful impact in the market. Customers, employees and vendors seeing this commitment gain feeling of trust in you and such trust breeds brand loyalty.

4. Ensures Security of Electronic Records
Data security is crucial in manufacturing, whether it’s regarding formulas, material substitution or sensitive reports and customer order details. One increasing concern is controlling breach of data security. ERP systems provide a complete set of security features including access controls, data encryption, and server based processing.

  • Data Encryption – ERP Security features give you visibility to transactional data
  • Audit Trails – Keeps records about all the revisions with their date and time in the master database.
  • Electronic Signatures -Secured transactions by an authorized operator maintains the security of transactions. It also creates a summary and detailed log of all transactions for audits.

5. Supplier Management and Qualification
With procurement from a verified and certified source turned mandatory in the Pharma industry, ERP ensures purchasing of material from certified vendors and keeps records for the best buy in the future. Along with maintaining vendor details like discount price and special offers, ERP also prompts when their certification is about to expire, ensuring compliance to the rule.

6. Enhanced Customer Experience
When quality, documentation, and traceability is taken care of well by ERP, the manufacturer is able to focus on other key factors of a business like customer management. The customer responsiveness is improved due to transparency in the system and the information is furnished on a blink of an eye. Pharma ERP also streamlines sample management and enables tracking customer complaints in an efficient manner.

A good compliance program can have significant, positive and noteworthy benefits on business operations. The advantages are many and vary with the nature of the business, but the above top six business benefits of compliance in the pharmaceutical industry are most prominent and cannot be overlooked. Implementing ERP helps in handling compliance in the pharmaceutical industry, which open doors for greater business opportunities within the country and outside too. It even keeps the warning letter, recall notices and other unwanted situations, bringing about huge benefits in the long run. So gear-up for compliant manufacturing and operations with an ERP that’s built specifically for the Pharma industry.



Sanjay Panjwani

Sanjay Panjwani is the Managing Director at BatchMaster Software, the leading provider of enterprise software solutions for process manufacturing industries. He’s on a mission to solve business challenges through innovation in ERP solution suites. You can connect with him on LinkedIn.