TEAM OF PHARMACEUTICAL DOCUMENT SPECIALISTS, FOCUSING ON EXPERT GENERATION AND QUALITY DRIVEN REVIEW ENSURING COMPLIANCE, PRECISION AND OPERATIONAL EXCELLENCE THROUGH THE PROJECT LIFECYCLE.
ORS
At ORS, we specialise in providing comprehensive technical documentation that supports the operational, engineering, and quality needs throughout the pharmaceutical project lifecycle. Our documentation services are designed to ensure that every aspect of your project is accurately captured, defined and agreed.
Our team of experienced technical writers collaborate to deliver key pharmaceutical documentation in line with your business needs. With a strong focus on operational excellence and adherence to global quality standards, ORS helps ensure your projects and processes are well-documented, compliant, and efficient.
Whether it’s supporting start-up processes, validating equipment, or ensuring stakeholder alignment, we deliver documentation that enhances transparency, reduces risk, and facilitates pharmaceutical compliance. ORS is committed to driving quality and operational success by delivering precise and well-structured documentation at every critical phase of your pharmaceutical project.
SERVICES
Expertise in Document Generation
At ORS, we understand that well-structured, clear, and compliant documents are critical to the success of pharmaceutical operations. Our team excels in generating a wide array of technical documents. With deep industry knowledge, we ensure that each document is generated with precision, reflecting the latest standards and regulatory expectations, while tailored to the specific needs of your processes and projects.
Thorough Document Review
A robust review process is integral to maintaining accuracy and compliance. At ORS, we conduct meticulous multi-layered reviews for every document, ensuring consistency, clarity, and alignment with regulatory and quality standards. This ensures that any errors or inconsistencies are caught and corrected, minimising any risks to project or process.
User Requirement Brief
User Requirement Specification
Exceptions & Clarifications Report
Design Qualification
Validation Master Plan
Quality Risk Assessment
System / Change Impact Assessment
Concept Design Report
Software Impact Assessment
Change Control
Factory Acceptance Test
Installation Qualification Protocol
Operation Qualification Protocol
Performance Qualification Protocol
Validation Report
Method Statements
Risk Assessment
FMEA
Risk Management Plan
Product Impact Assessment
Standard Operating Procedure
Master Batch Record
Process Gap Analysis
Training Policy & Plan
GMP Training Material
EXPERTISE
At ORS, we bring a wealth of expertise across the pharmaceutical project lifecycle. Our team consists of 20+ years of combined pharmaceutical experience resulting in a deep understanding of industry requirements. With hands-on experience in technical operations, manufacturing processes, and quality assurance, we ensure that your documentation meets not only regulatory standards but also operational best practices.
TECHNICAL PRECISION
Accuracy is non-negotiable in pharmaceutical documentation. Our technical writers and subject matter experts ensure that every report, protocol, and technical document is written with precision and clarity in line your business requirements. We focus on translating complex technical and engineering concepts into clear, compliant, and actionable documentation that supports both operational efficiency and regulatory compliance.
COMMITMENT TO QUALITY
At ORS, we hold ourselves to the highest quality standards. Our quality experience ensures that all documents are thoroughly reviewed, formatted, and verified to meet industry best practices and regulatory requirements. Whether it’s GMP protocols or validation reports, we are committed to delivering documentation that supports the highest level of operational and product quality.