Documentation

LSM Consulting specializes in large-scale standard operating procedure (SOP) gap analysis and remediation to maintain the highest levels of regulatory compliance, including: 

  • Comprehensive analysis against regulatory guidelines 

  • Development of process maps and procedural documentation 

Our SOP Remediation process starts with a full gap analysis to better understand your business needs, including which regulations you are required to follow and where vendors or partners may be handling certain aspects of your business and hold responsibility for related procedures. 

Next, we do a comprehensive assessment of your existing SOPs and documentation to assess whether revisions are needed to support your compliance with regulations or if there are gaps requiring the development of new SOPs or other controlled documents. Depending on the complexity and scope of the project, we can support development and execution of communication and change management plans to establish expectations up front with all key stakeholders and the organization as a whole.

Finally, we work closely with your functional area representatives to revise and develop SOPs in accordance with the approved remediation plan within the agreed-upon timelines. We have the flexibility to assemble a team of writers and editors, as needed, to support the most aggressive timelines. Our comprehensive project management approach ensures that you will have visibility to our progress every step of the way so that we can achieve successful outcomes, every time.

Our proven approach to developing controlled documents ensures clear, concise and accurate explanation of each process and the roles required to execute it as well as alignment with relevant regulations, documented job descriptions and training roles. 

CASE STUDY

A mid-sized biotech company came to us for urgent document remediation. They were facing a hard deadline that was about six months out, and after three failed attempts to remediate their SOPs using their available internal resources, they felt that they were in a “now or never” situation. 

To meet their needs, we brought in a regulatory expert. Our expert first assessed the biotech company to understand which of their processes were done in-house and which were conducted by vendors as well as the nature of their current business in order to determine exactly which regulatory guidelines applied to them. 

Based on our findings, we evaluated the company’s body of SOPs to determine where there were regulatory gaps. We assigned a risk value to each gap based on predetermined criteria to set priorities for the remediation. 

Once we had a sense of the volume of work needed, we assembled a team of technical writers who engaged the process owners to revise and, in some cases, create new SOPs based on the outcome of the regulatory assessment. We assigned a dedicated project manager to the project, who provided maximum support to the client by creating trackers, facilitating ongoing communications, identifying potential project risks and helping resolve them, and regularly sending out status updates.

Our robust communication plan helped the client engage stakeholders and monitor progress using the project dashboard we provided. LSM completed the project in just under six months, from start to finish, successfully remediating more than 100 company SOPs, many of which required significant revision.

LSM Consulting is a safety and training consultancy working in the pharmaceutical and medical device sectors. It has been operating in the United States serving international clientele since 2008.

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