Sitrof Technologies

Life Sciences companies—document and information-intensive businesses—operate under continual scrutiny from both domestic and international regulatory authorities.

Sitrof brings dozens of years of experience implementing content management and business process automation solutions for clients in the life sciences.

Mounting business pressures in pharmaceutical, biotechnology, medical device, health care, clinical services and other related industries require companies wring ever greater returns from their operations. In this unforgiving environment it is vital that organizations maintain compliance with governmental regulations such as the FDA's 21 CFR Part 11, the US Health Insurance Portability and Accountability Act (HIPAA), and other industry standards--efficiently and effectively.

Document Management Systems Implementation

Sitrof provides large and small life sciences, pharmaceutical and biotech firms with a full pre-start to finish, no bloatware, enterprise document management solutions. Sitrof provides needs analysis, product evaluations, recommendations, systems design, installation, integration with existing systems and validation, saving companies millions of dollars and mitigating risk. By blending top vendors solutions with Sitrof's decades of expertise in Document Management for Life Sciences, Sitrof helps organizations streamline document collaboration, approval, publishing, storage, archive and records retention while maintaining compliance.

Migration, Consolidation and Upgrades of Legacy Document Management Systems

Mergers and acquisitions permeate the life sciences industry, increasing the need to migrate and consolidate mission critical information and computer systems. Sitrof's depth and breadth of knowledge in all of the industry leading document management systems and content migration platforms, makes Sitrof the perfect choice. Content migrations and consolidations save organizations the hard costs of maintaining support contracts on multiple versions of legacy systems, retiring obsolete hardware, as well as softer savings in rapid retrieval of documents, reduced compliance risk due to multiple copies, re-deploying staff, or growing the business without increasing staff.

21 CFR Part 11 Compliance Modules for Document Management Systems

The industry-leading Document Management platforms do not arrive Part 11 compliant, so organizations are faced with two choices: write their own custom software to ensure compliance and doing the validation in-house, or turn to a trusted, experience adviser like Sitrof. Sitrof provides industry tested compliance modules for all of the major DMS Platforms including EMC Documentum, Microsoft SharePoint and Xerox DocuShare as well as systems validation services.

Secure Document Exchange

Life Sciences companies regularly collaborate with external partners, whether it's legal counsel, CROs. Documents such as contracts, informed consent, and protocols require authoring, review, and approval from individuals inside and outside the company. As the life sciences industry increases outsourcing efforts and the amount of unstructured content generated skyrockets, the need for affordable, secure document exchange becomes imperative. Failure to have a reliable, consistent, and compliant approach to document exchange and collaboration with relevant parties can result in unnecessary delays and additional costs. Sitrof offers peer-to-peer, secure document exchange with security and costs benefits over the traditional methods of sharing documents (email, fax and FTP). The ideal peer networking solution requires minimal end-user training and greatly reduces administration, resources, and maintenance from a central IT infrastructure, lowering overall costs and accelerating the investment payback.

Workflow Automation and Business Process Reengineering

Pharmaceutical companies face a growing challenge of managing their Standard Operating Procedure (SOP), marketing and regulatory documents. With the typical volume of documents increasing at 20% per year, paper-based approaches are very labor-intensive, expensive and error prone. Sitrof has decades of experience implementing workflow and document management systems to decrease review and approval times, reduce copying and shipping costs and provide better reporting capabilities thus streamlining the entire process.

Computer System Validation

For FDA-regulated companies, the cost of validation activities is now a major contributor to the both the initial and total cost of ownership of every system. Sitrof 's proven track record of executing validation projects that withstand FDA cGxP audits, whether Sitrof installed the initial system or not, makes us the perfect choice for validation services or providing your company with the necessary information to validate the systems in house.