Safe products are essential for the pharmaceutical industry. What is the role of change control in this? We explain.
Summary:
Our article explains why ERP is indispensable for approval processes in the pharmaceutical, medtech and biotech industries and how you can implement them.
Safety, quality, traceability: in the pharmaceutical industry, every step has to be right and documented seamlessly and audit-proof. The requirements of FDA 21 CFR Part 11 and ISO 13485 are strict and leave no room for maneuver. They demand control, transparency and security - supported by a system. The solution: a validated ERP system including an audit trail and electronic signatures.
In the pharmaceutical, medtech and biotech industries, documented approvals determine product approval, quality and company safety. This means that every step must be verifiable, tamper-proof and traceable, as well as auditable and legally compliant.
Audit trails and electronic signatures are not optional, but mandatory. Regulations such as FDA 21 CFR Part 11, EU GMP Annex 11 or ISO 13485 leave no room for maneuver: they require digital control, traceable data flows and validated systems.
The solution: a specialized ERP system that integrates audit trails and electronic signatures and supports validation - for compliance, process reliability and trust.
This US regulation governs the requirements for electronic signatures and digital documentation in regulated environments:
Annex 11 supplements the EU GMP guidelines specifically for IT-supported systems - with a focus on:
The international standard for quality management systems in medical technology places particular emphasis on
However, many companies in the pharmaceutical industry are still a long way from meeting the requirements as they continue to work in an analog way. This approach often leads to enormous effort and limited clarity, which is increasingly viewed critically by supervisory authorities.
Many deliberately opt for the analog approach due to the lack of reliable digital systems. However, in an industry characterized by precise requirements and strict regulations, this approach is becoming increasingly difficult to maintain.
Manual errors
Typing errors, duplicate entries and lost or incorrectly filed documents are expensive, time-consuming and can quickly become a problem in an audit.
Data silos
If quality, production and release data are distributed across different systems, it is easy to lose track of everything. Traceability? Not a chance.
Slow, non-transparent processes
Who released what and when? Without an audit trail, this remains unclear. This is particularly risky with multi-stage approvals.
No audit capability
Without a validated ERP system, there is a lack of audit-proof evidence. As this is crucial for audits, you will not be able to pass them, you will not receive any approvals and you will lose success on the market.
A specialized ERP industry solution not only manages data, but also controls pharmaceutical processes intelligently, transparently and traceably. It ensures seamless traceability, automated workflows, secure electronic signatures and end-to-end documentation - validated, compliant with FDA 21 CFR Part 11 and developed strictly in accordance with GAMP 5.
The most important functions:
Batch management
Traceability of substances, intermediate and end products in real time, batch-accurate and seamless.
Audit trail
Every relevant action is documented: User name, time stamp, action, reason for change are stored completely, unalterably and audit-proof.
Electronic signatures
Releases and approvals are digital, with secure authentication and clear assignment.
User & rights management
Only authorized persons have access to sensitive data and functions thanks to the role and authorization concept.
Quality controls
From incoming goods to the end product: flawless quality is a basic requirement for safe products. Test plans, limit values, deviations and measures are therefore managed digitally.
Long-term archiving & data integrity
The industry ERP stores audit trails, release data and quality certificates securely and permanently. The integrity of the data remains legally compliant for years and can be retrieved at any time.
Validation & GAMP 5 compliance
To ensure that you reliably meet the strict requirements, a suitable ERP industry solution is developed in accordance with GAMP5 best practices and is suitable for computer system validation.
The theory is one thing. But what does the practice look like? Here's an example.
The company's Qualified Person releases a batch. The system documents automatically:
Result: The release is traceable, secure, auditable and directly linked to the product batch. No paper, no doubt, no gaps.
In the pharmaceutical, medical technology and biotechnology industries, there is no regulatory future without digital traceability. Audit trails and electronic signatures are not just requirements, they are the digital backbone of your approval processes.
With the right ERP industry solution, you can master audits with confidence, speed up processes and ensure the long-term quality of your products.
Learn how our solution can make you audit-ready, efficient and future-proof!
Change control in the pharmaceutical industry – Beitrag öffnen
Safe products are essential for the pharmaceutical industry. What is the role of change control in this? We explain.
Success story: Hameln Pharma – Beitrag öffnen
Read how hameln pharma connects an external warehouse largely with a standard interface and saves time through automated processes.
Success story: Midas Pharma – Beitrag öffnen
Read the report to find out how Midas uses a direct warehouse connection to the external logistics provider and processes orders automatically.
