Quality and Compliance issues have started casting their shadow on India Inc., particularly, the Indian manufacturing sector. Sadly, newspapers almost every day are clogged with cases of recalls, events of medicinal tragedies, license cancellations, and likes. While sometimes these are genuinely an outcome of a company’s negligence, at others it may just be a defamation strategy by the competitors. That said, the truth is that many companies from the Pharma and Food & Beverages sectors of India are not being approved and accepted in global markets due to lack of emphasis on regulatory compliance – something that is indispensable for the bigger market countries.
This is the time for Indian process manufacturers to take a paradigm shift. Everything from health and consumables to services and utilities are under consumers’ and governing body’s scanners. Reasons: globalized markets, increasing consumer awareness and growing access to information through internet and media. Staying compliant is no more just a business choice, but a necessity to stay afloat and competitive.
So while it is placed in for a good reason, keeping abreast with countless regulations and managing compliance reporting can be a daunting task. In fact, as per a survey carried out by Deloitte and European Union in the year 2010, it was rated amongst the ‘Top unpleasant things that CFOs have to do’*. However, following and instituting them gives you a winning edge over your competitors and helps you win customer’s trust in the long run. What many companies don’t realize is that following compliance manually or through spreadsheets just ruins the purpose, makes the process even more complex, and increases the chances of hefty fines.
Step into the world of Enterprise Resource planning (ERP), which is like a backbone of enterprise transactions, planning, and operations. It enables a real-time access to information and automation of all your processes. This, in turn, ensures that your regulatory reporting requirements are not just met, but exceeded. As per a recent research, ERP implementation results in 58% improved regulatory compliance with their customized set of features and functionalities that include:
Compliances differ for industries.
Chemical companies have to follow the OSHA Hazard Communication Standards , GHS, and SARA Title III reports,
- Food & Beverages (F&B) companies have to abide by the FDA, Bio-Terrorism Act, and the HACCP.
- Pharmaceuticals are concerned with cGMPS, GxP, GAMP, FDA, and 21 CFR Part 11.
With the advent of verticalized or industry-specific ERPs, meeting these regulations is no more a time-consuming or toll-taking job.
One of the elementary requirements of regulatory compliance is the ability to trace lots and finished goods. ERP permits it for the entire supply chain from procurement to deliveries and vice-versa. ERP enables this through the functionality such as bi-directional lot/serial traceability and approvals for storage and transfer movements, which results in an improved customer responsiveness.
The need for quality maintenance is critical in a compliance-regulated environment, and it is mandatory in the entire supply chain and manufacturing processes too. ERP provides a comprehensive framework for managing product innovation with solid quality data management, along with quality process controls. ERP also Non-conformance, process inspections and tracking customer complaints in an efficient manner. The result is better products because quality-related issues are caught and addressed more quickly.
Data security is always a priority, be it regarding formulas/recipe, material substitution or sensitive reports, or customer order details. One increasing concern is controlling the breach of data security. ERP provides a complete set of security features including access controls, data encryption, and server-based processing.
In the industries like pharmaceuticals and cosmetics where approvals need signature verification, this feature of ERP is extremely useful. It supports secured transactions by an authorized operator along with the facility of digital signatures in the form of scanned text or images.
Revision, Versioning & Audit Trail
Formulas and their modification and substitution are highly important for any industry. ERP system keeps records about all the revisions along with their date, time and the reason for modification in the master database. Any addition, deletion, and modification in the database, triggers a mail to all the stakeholders, ensuring complete control over all the mission-critical data. Moreover, it allows creating a summary and detailed log of all transactions for audits.
Compliance Reports & Labels
Reporting has always been a matter of concern for companies in front of regulators and auditors. ERP streamlines your data processing, storage, and reporting functionality so that you can build the trust of regulatory auditors by delivering the regularly requested information quickly and correctly. The functionality of printing the labels in suitable formats with ingredient and allergen reporting makes it a must have for all the process manufacturing companies.
Improved visibility and better access controls
The major element of regulatory compliance is the visibility and transparency of business processes. ERP sanctions it for various processes, i.e. from acquiring the materials for production through final delivery to the customer, it enables tracking material flow, steps involved, precautions taken, practices followed, etc. to meet compliance guidelines. With ERPs, the key information is available in real-time for analysis, and reporting is faster.
Benefits an ERP can bring are many, but handling regulatory challenges is one such benefit that cannot be ignored to excel in your domain today. It can bring about the much-needed transparency, for your customers, auditors, and the governing regulatory bodies. Results: Improved brand image. Business. Repeated Business.