INFORMATION SERVICES

Life Sciences Manufacturing Process Documentation

Whether you’re in tech transfer or scaling up manufacturing, our Manufacturing Process Documentation service is here to streamline the development of your procedural documentation. To enable you to reduce human errors, easily onboard new hires, ensure GDP data integrity, and accelerate your product’s journey to market.

A specialised service ideal for...

Manufacturing Managers and Process Owners

Technical Transfer Leads

Documentation Managers

Regulatory Managers

Your Partner for Efficient Life sciences Manufacturing Documentation

Accelerate Your Product’s Journey to Market 

Whether you’re in tech transfer or scaling up manufacturing, we’re here to streamline the development of your procedural documentation. To enable you to reduce human errors, easily onboard new hires, ensure GDP data integrity, and accelerate your product’s journey to market. 

 

Supporting documentation and Quality teams, we work on paper and digital documents ranging from cleaning tickets and Batch Manufacturing Records (BMRs) to SOPs and Work Instructions (WIs) 

Due to changing regulations, process changes, and general content maintenance, engineers, technicians, and Quality professionals are required to tediously update and review large MS Word on a regular basis while also fulfilling their core duties. The sheer volume of documentation work can lead to employee frustration and extended review processes, which leads to Quality issues, increase in human errors, delayed production schedules, and sometimes spoiled batches 

Manufacturing managers and process owners

Our service takes the burden of documentation off your shoulders, allowing you to focus on core manufacturing activities. Ensure compliance, reduce errors, and get products to market faster.

Technical Transfer Leads

Simplify and expedite the transfer process with our specialised assistance. We eliminate bottlenecks, ensuring a smooth transition and reducing time-to-market.

Documentation Managers

Our expertise in documentation refinement, terminology, and formatting ensures consistent, high-quality documentation. Improve efficiency, reduce errors, and free up your team’s time. 

Regulatory managers

We help you compile and manage regulatory data effortlessly, reducing the time and effort required for regulatory compliance. Trust our specialists for accurate and compliant documentation. 

Our scaling service offering allows you take advantage of basic support right up to intelligent authoring solutions that can be powered by the latest AI technologies.

Option 1: Implementation of information design best practices.

Implement Information Design best practices to update, format and to re-design large documents such as BMRs to reduce human errors and speed up production.

Option 3: Writing, reviewing, and maintaining SOPs.

Working with the technical and quality teams, write, review and maintain SOPs to reduce the non-core workload and speed up document review processes and product manufacturing.  

Option 2: Review of procedural documents.

Review procedural documents such as SOPs to ensure they are clear and easily understood by the operators, which will minimise human error rates. 

 

 

Option 4: Adoption of digital and intelligent authoring solutions.

Moving to digital and intelligent authoring solutions to shorten the production time       

Why Choose TWi?

Achieve Industry Leadership Through Quality, Speed, Efficiency, and Collaboration.

Our specialist pharma writers, fast turnaround times, customisable engagement models, open and continuous communication, and unwavering commitment to process improvement empower you to achieve industry-leading document quality, reduced time-to-market, cost-effective operations, streamlined processes, and collaborative excellence.

a flexible, expert partner in life sciences manufacturing documentation

Only pay for what you need.

TWi’s outsourced documentation service can scale with the needs of your business as we often become an extension of the documentation or Quality teams where our content experts can be set-up within your IT environment, but you pay only for the work you need done. 

Ideal for companies facing challenges in:

Regulatory Compliance

Staying compliant in the rapidly evolving regulatory landscape is a daunting task for many life sciences companies. Our service ensures that your documentation is always in line with the latest regulations. We stay abreast of changes in regulatory requirements and adjust your documentation accordingly, minimising the risk of non-compliance.

Documentation Consistency

Consistency in documentation is vital for maintaining quality and clarity in life sciences manufacturing. Our service focuses on refining and standardising your documentation, from SOPs to Batch Manufacturing Records (BMRs). This approach reduces errors, streamlines training processes, and enhances overall operational efficiency.

Process Efficiency

Increasing process efficiency is vital for staying competitive in the life sciences industry. Our documentation services play a pivotal role in streamlining your manufacturing and technical processes. We help shorten production times and reduce bottlenecks. Our team works closely with yours to write, review, and maintain SOPs and other critical documents, reducing the non-core workload of your staff.

Partnering with Confidence

Increased Trust, Efficiency, and Business Success with TWi’s Life Sciences Manufacturing Process Documentation Service 

Rest assured, we have the expertise, understanding, and unwavering commitment to fulfil our promises. Our service minimises the need for SME assistance, ensuring a seamless and efficient partnership that empowers you to move forward confidently.