In today’s competitive economy, pharmaceutical and biotech companies are looking at faster ways for bringing innovation to market. Companies are trying to quickly create generics for eroding patents, introducing new brands or acquiring biotech companies for supplementing their existing product lines. Speed-to-market and the cost of doing the research in-house in developing new products, are key concerns which have resulted in a growth in laboratory outsourcing. 

While this is good news for the outsourcing facilities, it increases the competition among labs for contracts. Therefore, such labs not only need to have demonstrated experience, instrumental capabilities, and knowledge of key personnel relevant to the project, but their approach and commitment to quality and some certifiable level of compliance – GMP, GLP, ISO 17025, etc.  In order to grow and thrive, many of these contract labs are turning to automated quality management systems to integrate disparate processes, increase laboratory-wide transparency, meet regulatory requirements, optimize efficiency, cut costs and reduce potential risks.

Pilgrim Software helps contract laboratories meet, or exceed, their customers’ expectations by automating, streamlining, and effectively managing processes required to develop and maintain safe, high-quality and competitive products for those customers. With Pilgrim’s solution you:

Ensure Compliance
Contract laboratory facilities face increasing frequency of industry, quality, and safety challenges along with ongoing customer pressures.  The key in providing science-based, cost-effective services is to be in full compliance to various regulatory (GMP, GLP, ISO, USP, among others) requirements and have an effective and constant feedback loop with the customer.

Pilgrim’s integrated, closed-loop solution helps ensure compliance with these regulations, thereby minimizing risk, avoiding costly errors, and securing reputation. Its pre-built tools enable electronic signatures and automate regulatory recordkeeping, and help your company conduct safety and compliance monitoring through document management and SOP enforcement, nonconformance handling, corrective and preventive actions (CAPA), change management, internal audits, training, eLearning and employee certification, and even equipment calibration.

Reduce Cost
As the growth of the contract laboratory industry presses on, new economic pressures are rendering in-house, non-integrated and manual management systems ineffective or even obsolete.  Those systems frequently require paper-and labor-intensive processes and result in a lack of data visibility.  Impacts include higher IT administrative and overhead costs, less IT productivity, ineffective resource utilization, and a lack of communication with the contract customer. 

Pilgrim’s solution integrates people, processes, products/services and systems under one automated enterprise solution. This provides for timely data across the laboratory operation, reduces risk, and reduces the labor requirements by eliminating paper-intensive processes, and lowers administrative and overhead cost.   

Improve Efficiencies & Boost Productivity
Contract laboratory organizations are pressured to do more with less -- tighter budgets and less time. They are hindered by constraints resulting from inefficient document handling, communication with internal staff and the customers, identifying and resolving problems in product development and introductions, service delivery, managing supplier quality, maintaining equipment and ensuring a trained workforce.

Pilgrim’s solution enables contract laboratory facilities to meet or shorten timelines and drive down costs while being flexible and responsive to their customer’s changing needs.  It helps the lab keep current with changing regulatory requirements, and to prioritize projects and issues based upon risks and commitments.  Pilgrim’s solution provides resource management of key personnel needed at the right time with the right training for the right client.  Additionally, contract labs can easily establish and maintain effectiveness metrics, and developing audit and communication schedules back to the client to ensure work is progressing according to those agreed-upon metrics. 

Resources

White Papers

• Making the Grade: Quality Competence in Outsourced Formulation Labs (136.83 kB)
• FDA GLP Inspections - A Handbook to Preparing for a Successful Inspection: Part I (Excerpt)
• GLP vs. GMP Regulations: A Review of Their Intended Purposes and Requirements (Excerpt)
• FDA FAQ on Good Laboratory Practice